ACADEMIC SENATE: SAN DIEGO DIVISION, 0002 UCSD, LA JOLLA, CA 92093-0002 (858) 534-3640 FAX (858) 534-4528
May 11, 2020
PROFESSOR JAMES McKERROW, Dean Skaggs School of Pharmacy and Pharmaceutical Sciences
PROFESSOR JOSEPH MA, Professor of Clinical Pharmacy Skaggs School of Pharmacy and Pharmaceutical Sciences
PROFESSOR WILLIAMS ETTOUATI, Health Sciences Associate Clinical Professor NS Skaggs School of Pharmacy and Pharmaceutical Sciences
SUBJECT: Proposed MS in Drug Development and Product Management (online)
At its May 11, 2020 meeting, the Graduate Council approved the proposal to establish an online self- supporting degree program leading to the MS in Drug Development and Product Management. The Graduate Council will forward the proposal for placement on an upcoming Representative Assembly agenda.
Please note that proposers may not accept applications to the online program or admit students until systemwide review of the proposal is complete and the UC Office of the President has issued a final outcome. The Program may continue to accept applications and admit students to the existing in-person offering of the degree program.
Sincerely,
Lynn Russell, Chair Graduate Council cc: M. Allen J. Antony S. Constable R. Continetti M. Corr K. Hershon K. Oegema R. Rodriguez D. Salmon
Proposal for a Master of Science Degree in Drug Development and Product Management
PROPOSAL FOR A SELF-SUPPORTING PROGRAM OF GRADUATE STUDIES
MASTER OF SCIENCE DEGREE
In
DRUG DEVELOPMENT AND PRODUCT MANAGEMENT
(ONLINE)
May 4, 2020
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Proposal for a Master of Science Degree in Drug Development and Product Management
Contact Information
Submitter: James McKerrow, MD, PhD Dean UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Associate Vice Chancellor for Health Sciences UC San Diego 9500 Gilman Dr. Mail Code 0657 La Jolla, CA 92093 (858) 822-7801 [email protected]
Faculty Director: Joseph Ma, PharmD, FCP Professor of Clinical Pharmacy UC San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 9500 Gilman Drive, Mail Code 0714 La Jolla, CA 92093-0714 (858) 822.3485 [email protected]
Program Managing Director: Williams Ettouati, PharmD Director, Strategic Academic Program Development, Support Team Managing Director, Master’s Program in Drug Development and Product Management Health Sciences Associate Clinical Professor, N.S. UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Dr. Mail Code 1177 La Jolla, CA 92093 (858) 699-5489 [email protected]
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Proposal for a Master of Science Degree in Drug Development and Product Management
Table of Contents Executive Summary ...... 5 1 Introduction ...... 8 1.1 Program aims, objectives and features ...... 8 1.2 Historical development of the field ...... 9 1.3 Timetable for development of the program ...... 9 1.4 Relationship to existing UC San Diego and UC programs ...... 10 1.5 Contributions to Diversity ...... 11 1.6 Interrelationship of the program with other University of California Institutions ...... 16 1.7 Department which will administer the Program ...... 16 1.8 Program evaluation plan ...... 16 2 Program ...... 20 2.1 Undergraduate Preparation for Admission ...... 20 2.1.1 Admissions Requirements ...... 20 2.2 Foreign Language ...... 21 2.3 Program of study ...... 21 2.3.1 Specific Fields of Emphasis ...... 21 2.3.2 Plan Master II ...... 21 2.3.3 Unit Requirements ...... 21 2.3.4 Required Courses (Listed by Number of Units, Course name and number) ...... 22 2.3.5 Masters II Comprehensive Exam (Final Examination) ...... 22 2.3.6 Licensing or certification requirements ...... 22 2.4 Field Examinations ...... 23 2.5 Qualifying Examinations ...... 23 2.6 Thesis or Dissertation ...... 23 2.7 Final Examinations ...... 23 2.8 Special Requirements ...... 23 2.9 Relationship of master’s and doctor’s programs ...... 23 2.10 Special preparation for careers in teaching ...... 23 2.11 Sample Program ...... 23 2.12 Normative Time from matriculation to degree ...... 23 2.13 Online Delivery ...... 24 2.13.1 Teaching and Learning Commons ...... 24 2.13.2 Technical support ...... 26 2.13.3 Accessibility for Students with Disabilities ...... 26
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2.13.4 Online Course Design ...... 27 2.13.5 Academic Integrity in Online Exams ...... 28 2.13.6 Student Advising ...... 28 2.13.7 Learning Analytics and Assessment ...... 30 3 Projected Need ...... 30 3.1 Market assessment ...... 30 3.2 Placement estimates, and enrollment projections ...... 32 4 Faculty ...... 33 4.1 Steering Committee ...... 33 4.2 Core Faculty ...... 36 4.3 Voluntary Faculty ...... 41 5 Courses ...... 42 6 Resource Requirements and Impact on the Academic Unit ...... 49 6.1 Development Costs Associated with Movement to Online Delivery ...... 50 7 Graduate Student Support ...... 54 7.1 Financial Assistance ...... 54 8 Governance ...... 55 9 Changes in Senate Regulations Required ...... 55
Appendices:
A. Program and Pace of Study B. Market Assessment C. Admissions Criteria and Scoring Rubric D. Course Approval Forms E. Financial Projections / Cost Analysis F. Letters of Endorsement G. Catalog Copy H. Suggested UC and external reviewers I. DDPM Student Program Evaluation J. Student Historical Data K. Faculty Vitae
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Executive Summary Pharmaceutical products are developed with the intent of providing value to the health and welfare of society worldwide. The process for developing safe and effective products is a costly and high-risk venture. Likewise, the task of managing utilization and the cost of these products, once marketed, is an enormous challenge for health plans and systems. As a result, pharmaceutical companies, biotechnology companies, and managed care systems require extensive interdisciplinary planning and collaboration to ensure success. Most academic preparation for individuals working in these environments focuses on individually distinct professions, like pharmaceutical science or medical research, rather than on the breadth of knowledge required to understand the greater obstacles associated with drug development, utilization management, and processes that allow for collaborative innovation.
In 2017, a Master of Science degree program in Drug Development and Product Management (MS in DDPM) was approved as an on-site program at UC San Diego. The program has three central aims: first, give experienced professionals insights into the process of successful drug product development and deployment; second, to endow students with requisite knowledge and skills to collaborate effectively in the ongoing management of drug products; and third, to provide a solid, practical knowledge to bridge to employment opportunities in pharmaceutical, biotechnology, or managed care industries; or related regulatory agencies such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The second MS in DDPM program cohort at UC San Diego is currently attending courses in person for the 2019 -- 2020 academic year, with the third cohort now being recruited for the 2020 --2021 academic year.
The proposed online MS in DDPM is based on the existing in-residence MS in DDPM program at UC San Diego with some modifications. We propose that the program be offered online to make it more globally accessible, and more accessible to professionals who will continue to work while pursuing the degree. Online learning, also referred to as e-learning, is clearly a growing trend, with annual revenues reaching $107 billion in 2015, and projected to grow to $325 Billion by 20251.
Distinctive features of the program include instruction by faculty who possess scholarly understanding and industry experience; a case-based and project-oriented approach to learning; options in professional focus; online course delivery; exposure to international student colleagues with varied professional backgrounds; and the opportunity to learn from industry experts who serve as guest lecturers and course co-chairs.
The modality of instruction will be online beginning in the fall quarter of 2022. Recorded lectures and online learning activities will be introduced to supplement the teaching and learning process (“hybrid” or “flipped” format). Confidence regarding market, faculty, curriculum, and student placement has been established during the initial two years of the MS in
1 https://www.forbes.com/sites/tjmccue/2018/07/31/e-learning-climbing-to-325-billion-by-2025-uf-canvas- absorb-schoology-moodle/#411588163b39
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DDPM.
The UC San Diego Research and Assessment Hub in the Teaching and Learning Commons will work closely with the MS in DDPM team to design the course level and program level assessment plan to ensure the highest standards of instruction and learning outcomes for the MS in DDPM degree program.
This degree is consistent with the campus priority to recruit more graduate-level professionally oriented students, and thus more competitively serve the biotech and pharmaceutical industries so closely tied to the work at UC San Diego. This degree program benefits greatly from participation in curricular development from organizations across Health Sciences, including the Center for Drug Discovery Innovation at the Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS). UC San Diego Division of Health Sciences is committed to creating a globally accessible graduate program in drug development and product management, and be a key part of the translational research process, helping reinforce that UC San Diego is a world- class center for clinical and translational research.
All UC San Diego Graduate Division and Graduate Council requirements for master’s degrees will be met by this program. No GRE exam will be required as the target audience is working professionals; instead, work experience, letters of recommendation, candidate statements and prior academic achievements will be considered for admission. Work experience in a relevant field will be required. The program will strive to recruit students with diverse professional backgrounds including scientific, medical, and business management.
The degree requires 36 total units of online study over a minimum of three quarters. All students must pass a Master’s Examination to earn the MS in DDPM degree per UC San Diego Senate requirement 700-C.
The program will maintain a ratio of one advisor for no more than twelve students. Suitable university and industry advisors will be recruited to assist the program’s core faculty advising team in this important student advisory role.
The program is fully self-funded. Based on a market assessment and anticipated student placement, the program leadership is confident it can enroll 65 new students in the inaugural year of online offering and increase the number of students in the cohort each year during the stabilization phase until year 5 when enrollments will be capped at 110 students. The budget meets all direct and indirect financial commitments, including assigned assessments for the division, the relevant vice chancellor, and the office of the chancellor. This program will be managed by SSPPS, which will have control over curriculum, faculty selection and review, admissions, and student evaluation. Additionally, SSPPS will provide oversight of program directors, selection of learning objectives, curriculum topics, and relations with industry and employers in order to ensure the effort is well coordinated and supportive of overall Health Sciences strategy.
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Administrative support for the program will be provided by UC San Diego Extension under the direction of SSPPS. The MS in DDPM program will be designed and implemented utilizing resources available through the Strategic Academic Program Development (SAPD) initiative, with the Education Research and Assessment Hub in the Teaching and Learning Commons providing guidance and direction for developing the courses and program for the online degree. UC San Diego Extension will support the admissions process, program administrative policies, financial management, and provide instructor and student services. UC San Diego Extension has extensive experience in administering self-supporting professionally oriented degree programs at UC San Diego.
Once approved for online delivery, the MS in DDPM will be offered exclusively online and the residential MS in DDPM will be discontinued with the graduating 2021 – 22 cohort in June 2022.
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1 Introduction 1.1 Program aims, objectives and features Pharmaceutical products are developed with the intent of providing value to the health and welfare of society worldwide. The process for developing safe and effective products is a costly and high-risk venture. Likewise, the task of managing utilization and the cost of these products, once marketed, is an enormous challenge for health plans and systems. As a result, pharmaceutical companies, biotechnology companies, and managed care systems require extensive interdisciplinary planning and collaboration to ensure success. Most academic preparation for individuals working in these environments focuses on individually distinct professions, like pharmaceutical science or medical research, rather than on the breadth of knowledge required to understand the greater obstacles associated with drug development, utilization management, and processes that allow for collaborative innovation.
The proposed online master’s degree program in Drug Development and Product Management (MS in DDPM) has three aims: first, to give experienced professionals insight into the process of successful drug product development and deployment; second, to endow students with requisite knowledge and skill to collaborate effectively in the ongoing management of drug products; and third, to provide a solid, practical bridge to employment opportunities in pharmaceutical, biotechnology, and managed care industries or related government agencies such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Distinctive features of the program include instruction by a combination of faculty who possess scholarly understanding and industry experience; provide a case-based and project-oriented approach to learning, with options in professional focus; online course delivery; exposure to student colleagues with varied professional and international backgrounds; and connections with employers featured as course chairs and guest lecturers.
Once approved for online delivery, the MS in DDPM will be offered exclusively online and the residential MS in DDPM will be discontinued with the graduating 2021 – 22 cohort in June 2022.
The proposed online degree program will be led by faculty from the Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS), and faculty from the School of Medicine may also participate. This online degree program will not affect the existing graduate degree programs because faculty participating in this program will be teaching via overload and compensated accordingly. Additionally, professionals from industry with advanced degrees (MD, PhD, PharmD, JD, and MBA) will serve as instructors for a variety of courses. A list of current program faculty participating,
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including their teaching and/or advising commitments is included in section 4.0 of this document. In addition, a letter from Dr. Joan Heller Brown, head of Pharmacology at the School of Medicine, endorsing the creation of the program can be found in Appendix F of this document.
1.2 Historical development of the field Scientific advances have led to drug discoveries that save and/or improve human lives. The cost to develop a new prescription drug from discovery through market approval is estimated to be $2.6 billion, a 145% increase from 2003 to 2014.2 These high development costs contribute to the high costs of new products. For example, Alirocumab, a drug approved in 2015 to treat high levels of LDL cholesterol, is priced at nearly $15,000 per year.3 In addition, new medications offering breakthrough benefits are expensive for both healthcare systems and patients.
Professionals with the knowledge and skills to manage processes across the spectrum of drug discovery to drug approval and marketing are needed in order to develop safe and effective drugs. Efficiencies in development can allow for a cost- efficient drug development process. After a drug is approved, and the company is recouping their high development costs, knowledge of the post-approval research and marketing space is required to help manage worldwide drug utilization and cost to health plans and systems.
Unfortunately, development of these skills is often left to the employer through on- the-job training. To fill this gap, we have created a professionally oriented graduate degree program in DDPM to meet the needs of employers. These professional graduate programs provide students with the practical knowledge of industry dynamics allowing them to advance professionally at an accelerated rate. In a recent study by the Education Advisory Board, Academic Affairs Forum, an evaluation in 2015 found the fastest growing segment of higher education is the professional master’s degree focused on specific job knowledge and skills that help students obtain either a new job or advance in an existing department.4
1.3 Timetable for development of the program We propose to offer the MS in DDPM program in a fully online format to a global audience in fall of 2022. This degree was first offered fall 2018 as a residential UC San Diego degree program. Through the initial phase of the program, which has its second cohort currently attending courses in a face-to-face format with students in residence at UC San Diego, the MS in DDPM steering committee now better understands the teaching requirements of the students and program. This
2 (http://cen.acs.org/articles/92/web/2014/11/Tufts-Study-Finds-Big-Rise.html) 3 (http://www.latimes.com/business/la-fi-agenda-specialty-drugs-20150921-story.html) 4 EAB, Understanding the Changing Market for Professional Master’s Programs, 2015.
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knowledge has been used to design a better online program that will introduce a series of recorded lectures and online learning activities that will achieve the desired learning process (“hybrid” or “flipped” format).
Approval and introduction of the online MS in DDPM program does not affect the campus enrollment plan because it will be entirely self-funded. The online MS in DDPM program does, however, strongly contribute to the UC San Diego strategy of growing graduate enrollment through new master’s degree programs with global reach.
The proposed timeline for the evolution of the online program is as follows: Review and endorsement by SAPD (November 2018 approved) SSPPS CEP review and approval (February 2019 approved) SSPPS Dean’s review and endorsement (February 2019 approved) Health Sciences Faculty Council review and approval (March 5, 2019 approved) Health Sciences Vice Chancellor (March 2019 approved) UC San Diego EVC administrative review and approval (April 2019 approved) UC San Diego Academic Senate (Graduate Council) review (March 2020) System-wide and CPEC, and OP review (March 2020) WASC proposal review (January 2021 – March 2021) Recruit first cohort of 65 online students (March 2021 – 2022) Application and admissions (late spring 2022) Begin first fully online courses (fall of 2022) Graduate first cohort and track job placement (summer and fall of 2023)
1.4 Relationship to existing UC San Diego and UC programs UC San Diego has both the depth and breadth in the field of drug discovery and product management to support a MS in DDPM. SSPPS, which was created in July of 2000, has a current enrollment of 250 PharmD students. The school offers an innovative curriculum taught by a diverse and experienced health sciences faculty who are closely aligned with the clinical, research and academic programs of the School of Medicine.
Creating a globally accessible graduate program in drug development and product management will contribute to the recognition of UC San Diego as a world-class center for clinical and translational research, since drug development and management is a key part of the translational research process. The MS in DDPM also fulfils a high campus priority to recruit more graduate-level professionally oriented students, and more competitively serve the science industries so closely tied to the work at UC San Diego. A letter from Gary S. Firestein, MD, Dean and Associate Vice Chancellor of Translational Medicine at UC San Diego (CTRI), further delineating the
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importance of this program to UC San Diego can be found in Appendix F of this document.
Furthermore, the MS in DDPM is interdisciplinary and spans the breadth of drug development within a pharmaceutical company and beyond to the management of drug products within healthcare systems. The MS in DDPM program is particularly competitive on its Entrepreneurship and Intellectual Property course. The interdisciplinary nature of the MS in DDPM program makes it relatively unique among programs with its blend of courses covering regulatory science, clinical sciences and pharmaceutical business. A letter of endorsement from Michael K. Gilson, MD, PhD, Professor and Chair in Computer-Aided Drug Design and Co- Director, UC San Diego Center for Drug Discovery Innovation supports this program as furthering the mission of the University of California and can be found in Appendix F of this document.
UC San Diego faculty, students, and administrators actively collaborate with the professional community to solve scientific and professional challenges. The MS in DDPM complements this approach. For example, the SSPPS Applied Pharmacoeconomic and Outcomes Research Forum, now in its 10th year, is an example of an initiative that facilitates problem-solving for cost-effective drug development and management across stakeholder groups, including pharmaceutical/biotech, managed care organizations, government agencies, medical centers, and academia.
The effect of the MS in DDPM on other programs at UC San Diego will be minimal. For example, the Rady School of Management offers innovation coursework that is purposely broad to allow students to explore innovation in a wide variety of industries, and it emphasizes the application of analytical frameworks to validate the market potential of any type of new product idea, as opposed to the specific process- oriented framework to launch and manage drug products covered in this proposed program. In fact, the proposed MS in DDPM program will serve as an academic complement to the work at the business school and will further solidify UC San Diego’s commitment to the biotechnology, pharmaceutical and managed care industries.
Any other programs at UC San Diego related to biology, pharmacology, or biotechnical topics are primarily scientific in focus, and thus serve a different purpose, target market, and industry need.
1.5 Contributions to Diversity The MS in DDPM program leaders are dedicated to equity, diversity and inclusion and are committed to enhancing accessibility for all students. As a professional degree program, we are preparing students for success in top organizations and companies. These organizations and companies thrive by hiring talented individuals from various
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backgrounds, and accordingly we strive to include members of diverse communities in our cohort so their perspectives and experiences will enrich the program.
Our outreach and marketing strategy is based in equity, diversity and inclusion. Certain marketing and outreach efforts will be made to directly target underserved communities through organizations such as the Society for Advancement of Chicanos/Hispanics and Native Americans in Science (SACNAS), which is inclusive in its membership. According to the SACNAS website, 40% of its members are pursuing careers in Life Sciences (https://www.sacnas.org/). We will utilize LinkedIn and other social media to market to diverse groups such as Women of Color in Pharma (https://wocip.org/). Lastly, the program will collaborate and align its goals with the Graduate Division’s diversity and inclusion outreach efforts, such as the Annual Biomedical Research Conference for Minority Students (https://www.abrcms.org). The UC San Diego Extension Marketing team will help direct marketing and outreach efforts to reach diverse populations.
The DDPM program leadership is committed to diversity and inclusion, and we have set our diversity goals to align with or exceed by 20% of what the pharmaceutical/biotech industry currently reports in their most recent data about employed URM in these industries. According to the most recent data available from the U.S. Bureau of Labor Statistics (https://www.bls.gov/cps/cpsaat18.htm), 7% of the pharmaceutical and medicine manufacturing workforce is comprised of individuals identifying their race as Black or African American and 16% identifying their ethnicity as Hispanic or Latinx. Women represent 39.4% of this workforce according to the 2019 report. The first DDPM cohort was comprised of 67% women, while the second cohort comprises 72% women (see Feb 6 Memo response for statistical breakdown by year). Six percent of the first student cohort self-reported as URM, while the current student cohort self-reported at 20% URM. We are pleased that the representation of women in the program is well above industry percentages, and that the URM from year one to year two more than doubled.
Traditional minority groups in America have reported that lack of support, linguistic differences, and study skills as key factors for gaps in learning in an online environment. However, factors such as flexibility, time convenience, and self- confidence positively influenced academic performance5. Our faculty actively vest in the success of all students, and faculty and staff have and will participate in diversity trainings and other related trainings provided by campus (https://blink.ucsd.edu/HR/training/roadmaps/diversity-inclusion.html and https://commons.ucsd.edu/what/edi.html) to expand our diversity fluency). These
5 Yeboah, A.K. & Smith, P. (2016, December). Relationships Between Minority Students Online Learning Experiences and Academic Performance. Online Learning, Volume 20(4).
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efforts will allow us to track and respond to the needs of our students in order to facilitate success.
The admissions committee conducts a holistic review process that considers the work experience of each applicant, letters of recommendation, and an applicant’s statement of intent about why this master’s degree program will help advance their career. Subsequently, for any potential applicant, an in-person or teleconference interview is conducted. We do not require the GRE with the understanding that the GRE test scores may not reveal the potential of an applicant, and that it is often associated with impeding the academic advancement of URM.
Marketing efforts to meet our diversity goals: To help increase access and opportunities for URMs to enroll in the DDPM program, key tactics will be to expand communication, marketing, and recruitment efforts. Marketing the program relies on a team of knowledgeable and diverse individuals who consider inclusion at each stage of the marketing process from inception to distribution. To reach our goal of a diverse and inclusive student population, our Digital Marketing Team targets potential students in three central areas: those in the scientific, medical, pharma, business management, or legal backgrounds who need specialized drug development and product management skills for career growth; those looking for advancement in pharmaceutical and managed care industries or related government agencies, such as the U.S. Food and Drug Administration or the European Medicines Agency; those who are looking to get out of the lab and into management positions.
Inclusive Advertising: A core component behind our advertising strategy is inclusion. As some level of audience targeting is required during audience creation in digital advertising, we build audiences focused on interest- based behavior, education level, work experience, and job titles. We avoid exclusions based on race, gender, religion, sexual orientation, income, and political views. This strategy allows us to target potential students based on their interest and program readiness.
Inclusive Creative: In our marketing pieces, we use imagery that represents our current student base as well as those who we are actively recruiting. This includes women and other underrepresented minorities.
Diversity Plan: specific efforts to reach our diversity goals Our recruitment and marketing efforts target companies, associations, and LinkedIn groups (several listed below) that will help us attract diverse students. Many companies have stated commitment to diversity and inclusion (see web links). o Women Leaders in Pharma https://www.linkedin.com/company/women-leaders-in-pharma/ o Women of Color in Pharma https://wocip.org/ and
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https://www.linkedin.com/company/wocip/ o National Hispanic Medical Association https://www.linkedin.com/company/national-hispanic-medical- association/ o The National Biotechnology & Pharmaceutical Association (NBPA) (national, independent, non-profit professional membership organization for African-Americans and Blacks in the life sciences and pharmaceutical industry) https://www.linkedin.com/company/national-biotechnology-&- pharmaceutical-association/about/ o Biotech & Pharma Professionals Network https://www.linkedin.com/company/biotech-&-pharma-professionals- network/about/ o Roche https://www.roche.com/careers/for_employees/diversity.htm o Glaxco Smith and Klein https://www.gsk.com/en- gb/responsibility/our-people/inclusion-and-diversity/ o Kaiser https://www.kaiserpermanentejobs.org/diversity-and- inclusion/ o Pfizer https://careers.pfizer.com/en/diversity-inclusion o J&J and JLabs https://www.jnj.com/about-jnj/diversity We will collaborate with UC San Diego’s Graduate Division and the School of Medicine to ensure program representation at the following conferences and job fairs: o National McNair Conference and McNair Scholars Research Conference https://www.aap.ucla.edu/about-aap/overview/ o GEM conference http://www.gemfellowship.org/ o National Indian Education Association (NIEA) http://www.niea.org/programs/convention-and-trade-show/ o Biomedical Engineering Society (BMES) https://www.bmes.org/annualmeeting o American Indian Science and Engineering Society Once approved for online delivery, the MS in DDPM will be offered exclusively online and the residential MS in DDPM will be discontinued with the graduating 2021 – 22 cohort in June 2022. o SACNAS http://sacnas.org/what-we-do/conference/ o Northern California Forum for Diversity in Graduate Education https://www.caldiversityforum.org/ o Annual Biomedical Research Conference for Minority Students https://www.abrcms.org/ o OSTEM conference https://ostem.org/page/8th-annual-ostem- conference We will advertise to graduates of UC and CSU schools in appropriate majors and in collaboration with Graduate Division. This is an online degree, and we are recruiting beyond California to potential students who have already
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completed their undergraduate degrees and have worked for several years. Nevertheless, we feel it is important to reach out to the diverse undergraduate population so that they will be informed of career and educational opportunities after their graduation. Pre-degree summer training programs are not applicable for the online degree program. Yet, it is fully our intention to increase retention and success of diverse students and will refer them to virtual campus resources as appropriate (The Commons, Black Resource Center, Women’s Center, LGBT Resource Center, Cross-Cultural Center, Raza Resource Centro, etc., all offer virtual services). A mechanism within industry to provide tuition support for qualified employees already exists. UCSD and the MS in DDPM program regularly collaborate with these employers, and the Outreach Manager assists with coordination of third-party payments when tuition is paid by the companies. We will provide targeted financial aid, as financial considerations are often a barrier for students to attend the program. Scholarships are awarded based on merit and factors that enhance diversity in the program. These scholarships will help reduce financial barriers and improve access to the program for students from underserved communities. Additionally, the online program format will enable students to pursue the MS in DDPM without the costs associated with relocation and loss of income. Once matriculated, students may be allowed to change their pace of study with the permission of the Program Faculty Director. Flexible completion dates and part-time enrollment will be approved of on a case by case basis and will be coordinated with the assistance of the MS in DDPM Program Coordinator.
The following information will be featured on the program website and program marketing collateral:
What is EDI (Equity, Diversity, and Inclusion) at UC San Diego?
Diversity refers to the variety of personal experiences, values, and worldviews that arise from differences of culture and circumstance. Such differences include race, ethnicity, gender, age, religion, political views, language, abilities/disabilities, sexual orientation, socioeconomic status, and geographic region.
Equity is the guarantee of fair treatment, access, opportunity, and advancement for all students, faculty, and staff, while at the same time striving to identify and eliminate barriers that have prevented the full participation of marginalized groups.
Inclusion is the act of creating environments in which any individual or group can feel
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welcomed, respected, supported, and valued.
1.6 Interrelationship of the program with other University of California Institutions UC San Diego features Centers and Institutes such as the Center for Drug Discovery Innovation (CDDI) that help connect researchers with promising projects with the information and capabilities needed to make real scientific advancements. These collaborations work across UC campuses. For example, the UC San Diego Center for Translational Computer-Aided Drug Discovery & Project Management is fundamental in helping scientists create new molecular entities to target novel drugs and create new and innovative potential drug therapies.
In addition to cross campus collaborations, the UC San Diego Health Sciences has robust relationships with internationally recognized pharmaceutical and biotechnology companies, managed healthcare systems, and government agencies. Surrounding the UC San Diego campus are numerous research and development companies devoted to biotechnology and pharmaceutical development, including many developed by or with UC San Diego faculty. Furthermore, San Diego County ranks third in the state of California for life-science jobs.6 The San Diego region hosts five healthcare systems and is one of the more progressive geographic regions for research and patient care.
1.7 Department which will administer the Program This program will be managed by SSPPS which will provide direction over curriculum, faculty selection and review, admissions, and student evaluation. Additionally, SSPPS will provide the oversight of program directors, selection of learning objectives, curriculum topics, and relationships with industry and employers in order to ensure the effort is well coordinated and supportive of the overall Health Sciences strategy. Under the direction of SSPPS, UC San Diego Extension will support student recruitment and the admissions process, develop and execute program administrative policies, oversee financial management, and provide instructor and student servicing.
1.8 Program evaluation plan To ensure the highest quality program, the MS in Drug Development and Product Management program will be subject to regular review by the SSPPS Committee on Education Policy (CEP) with special attention to program changes since this is a new program with new courses.
The program leadership will submit an evaluation plan to the Academic Senate for review as recommended for new online degree programs on an annual basis during
6 https://www.sandiegouniontribune.com/business/biotech/sd-me-biotech-report-20171115-story.html
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the first five years following establishment. This is explained in more detail below and will include: 1. completion rates for individual classes 2. completion rates for the degree program 3. average time for degree completion 4. demographic information 5. each statistic in 1-4 broken down by demographic category 6. course, and professor response surveys, including student comments and peer instruction reviews 7. an evaluation from Digital Learning in the Teaching + Learning Commons 8. financial data
The MS in DDPM team will work with the Education Research and Assessment Hub in the Teaching + Learning Commons to develop course-level and program-level assessment plans. The assessment plans will determine: • The student learning outcomes for each course and for the program • The evidence that will be collected to determine learning effectiveness • How the evidence will be used to improve the courses and program
While the MS in DDPM program is currently offered as a residential MS program, once it is offered online it will benefit from frequent reviews and modifications. Program evaluation will include the following elements: (1) All program courses and faculty will be evaluated by each student. Results will be reviewed with the faculty and the program steering committee for the purpose of continuous program quality improvement. The evaluation tool is designed in the UC San Diego licensed Qualtrics. (2) Students will be encouraged to provide feedback to their academic advisor on a regular basis regarding individual courses and/or the overall learning experience. (3) Student performance will be carefully evaluated to ensure program instruction is effective and to ensure students are meeting program objectives and expectations. Student performance data will also be used to help determine necessary course or program improvements. All courses in the program will use the standard letter grading system. (4) The program will maintain ongoing communication with alumni to monitor and report employment and professional achievements. (5) The program will adhere to the standard Academic Senate program review cycle.
In addition, we have developed metrics that will be used to define program success in our assessment plan. The metrics and goals have been selected based on how they contribute to the program objectives. These metrics are placed in the context of an evaluation framework, such as that proposed in the 9/9/19 draft prepared by the Commons in consultation with the Executive Vice Chancellor’s office.
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Below are the goals that the DDPM program has for the following metrics of success, which will be tracked and reported annually (also see Appendix J MS in DDPM Student Historical Data):
1. Completion of degree. We will track the completion of the degree for all enrolled students, including time to complete the degrees (# of quarters, leaves of absence, etc). This is described in the proposal Section 1.8 Program Evaluation plan on pages 14-15. We are pleased to report that for the first cohort, 100% of enrolling students completed the degree.
2. Placement/Employment of graduates (current, expected online, goal). This metric will continue to be coordinated by the DDPM Outreach Manager who tracks alumni progress. The current status of the alumni of 2019 is included in question 10 of this memo.
3. Diversity of students (current, expected online, goal) is and will be tracked annually. We track the demographics and admissions statistics of our students based on self-reported information from the application (see Feb 6 memo attached page 1-2 for breakdown for the 2018-19 and 2019-20 cohorts). Anticipated enrollment in the online program can be found in the proposal pages 26-27, Table 1 Projected Enrollment. Expected differences in enrollments of the residential compared to online is that we expect a significant international demand for the online, as well as additional students from outside of California, compared to the residential program.
4. Networking-related connections (alumni, faculty, guest lecturers; student reported). Networking opportunities will be coordinated and tracked by the DDPM Outreach Manager. Our goal will be to conduct at least two networking events annually that bring together current DDPM students, alumni, faculty, and invited guests from the local biotechnology and pharmaceutical industries. We also aim to feature at least 20% of the lectures with guests from industry across all DDPM classes to provide students with opportunities to network. Finally, the DDPM Strategic Advisory Board will continue to be comprised of leaders and executives who can facilitate additional networking opportunities for our students and graduates.
5. Internal (Self) evaluations. Faculty with staff do and will conduct annual internal evaluations to track perceived strengths and weaknesses, successes and needs. A detailed critique of the in-person DDPM program was provided in the February 6 memo in response to Question 1c. In brief, the strengths of the program lie in the curriculum, specifically in the drug development and product management content. The inclusion of both domains of knowledge was a strength compared to competing master’s programs whereby the sole
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domain of knowledge was in drug development. To date, our program has a strong value proposition providing students scientific drug development applicable skills and biotech specific management skills in marketing, entrepreneurship, and business development. Another strength was the quality of individuals who served as course chair(s) and guest lecturer(s) as several of them were employed locally in the pharmaceutical/biotech industries and provided content expertise. A weakness that we observed over the 2018 – 2019 academic year was periodic student absences from courses. The primary reason for the absences was mainly related to work schedules and other issues that prevented students from being able to attend the in- person DDPM course in the evening. The successes of the program were student and faculty satisfaction with small group discussion and the utilization of case studies for assessment. One area identified for improvement is the ability to attract and recruit candidates who reside outside of Southern California and have strong biotech experience. We will continue to monitor our ability to attract strong talent from across the U.S. and internationally.
6. Annual student response surveys: For the in-person program, qualitative evaluations were provided by students. For the online program, we have developed a 20-item program evaluation survey to be completed by student at the end of the program. The program evaluation survey will utilize a Likert- based scale and will have open-ended questions. We will assess help and support for student learning, resources to support learning, and evaluation of student learning. The open-ended questions will assess program likes, dislikes, and suggested improvement. Responses marked as “Agree” and “Strongly Agree” via the Likert-based scale will be considered favorable remarks. See Appendix I.
7. Financial information. The self-funded program reconciles the budget annually to ensure program revenues do not exceed expenses. Any surpluses are reinvested into the program. A detailed budget is attached in Appendix E.
The program leadership anticipate a growing demand for the online MS in Drug Development and Product Management degree as the pharmaceutical and biotechnology fields continue to expand. However, as a self-funded program, SSPPS should discontinue the online program if enrollments numbers fail to produce a revenue stream that exceeds expenses three years in a row. Of note is that the current residential program will have reserves in the second year. Reserves will be reinvested into the program. If the normative time to completion of the degree, class completion rate, and degree completion rate exceed what is acceptable by UC San Diego Graduate Division, the program leadership will reexamine admissions policies. It is the intention of faculty to only admit students that have the aptitude for and will clearly benefit from earning the MS degree, and to commit the resources necessary to help students succeed. With stringent admissions policies, attrition rates should
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be low. Faculty from SSPPS and School of Medicine are fully engaged, and the program has had no issue recruiting industry professionals with advanced degrees to chair courses. Given San Diego’s booming biotech industry, we do not anticipate future difficulties with faculty involvement.
2 Program 2.1 Undergraduate Preparation for Admission All UC San Diego Graduate Division admissions requirements will be met by this program, including possession of an undergraduate degree. The GRE exam will not be required as the target audience is working professionals; instead, work experience and achievements will be considered. A minimum of one to two years of work experience in a relevant field will be expected. While the admissions committee will consider applicants with a variety of undergraduate degrees, stronger candidates will be those with degrees in the sciences (chemistry, biochemistry, biology, and physics), business, finance and marketing.
2.1.1 Admissions Requirements Applicants will be required to submit a statement outlining their intended career focus (i.e., “statement of purpose”) during the program, and a description of any current or potential employer relationships they already have. The statement should also describe their plan for leveraging the degree to achieve their career goals and how the degree will help develop their professional networks. These required components of the statement of purpose will be explained to the applicants on the program website and within the application.
Three letters of reference, including at least one from a relevant employer, will be required as well. The program will strive to strike for a student cohort balanced between scientific, medical, business management, and legal backgrounds. Diversity of the students’ backgrounds is an important priority for this program. Active recruitment efforts will include ensuring a diversified student base in terms of professional, academic, international and ethnic backgrounds.
Two faculty members of the MS in DDPM steering committee will interview all qualified applicants by video conference prior to offering admission. The interviews will be conducted through ZOOM calls. A scoring rubric will be used for admissions, and factors noted during the interview process will be taken into consideration, in Part Four of the scoring rubric (see Appendix C).
Appendix C includes a scoring rubric (currently used during the admission process for the UC San Diego Crest/MAS programs) that will be used for all program applicants. The rubric takes into account all of the elements described above, and also reflects the consideration of factors obtained during an interview with each qualified applicant (i.e., scoring 70 or better) as part of the overall admissions
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process. The program will not allow revenue considerations to influence admissions decisions. Admissions decisions will be based upon educational background and performance, professional experience, letters of recommendation, clarity of career goals and networks, and the interview.
An admissions committee of core faculty will review all applicants and make all admission recommendations. The members of the admission committee will receive training provided by UC San Diego to address issues such as implicit bias. The demographics of each cohort will be evaluated to ensure there is a good balance of males, females, URMs, and representatives from various and relevant industries.
2.2 Foreign Language There is no foreign language competency requirement to qualify for this program. As all instruction will take place in English, international students from non-English speaking countries will be required to submit a TOEFL score of at least 85 for admission to be consistent with the current minimum UC San Diego requirement https://grad.ucsd.edu/admissions/requirements/international-students/english- proficiency.html.
2.3 Program of study This degree will be a Master of Science in Drug Development and Product Management. Although this program is professional in nature, comparable programs throughout the country (see section 3.1 Market Assessment - degrees associated with science-based professions like drug development usually expect a science background. Once approved for online delivery, the MS in DDPM will be offered exclusively online and the residential MS in DDPM will be discontinued with the graduating 2021 – 22 cohort in June 2022. The content and quality of the online program is expected to be the same as the in-person, on-campus program; only the delivery of the program will change. The term “online” will not be used in the degree name or in describing programs as “online” on University transcripts.
2.3.1 Specific Fields of Emphasis Drug Development and Drug Commercialization, and Drug Utilization
2.3.2 Plan Master II A comprehensive exam will be administered at the end of the final quarter of study
2.3.3 Unit Requirements The program requires successful completion of 36 total units over three quarters (12 units per quarter). All 36 units are necessary for graduation, and all courses are required. There are no elective courses. Students are expected to maintain a minimum GPA of 3.00. The list of courses and pace of study is outlined in Appendix A of this document.
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As the program matures, course content could be refined based on the preparation and career interests of admitted students, as well as the expressed needs of employers. Any changes to the program plan would be presented to the Graduate Council for review and approval at that time.
2.3.4 Required Courses (Listed by Number of Units, Course name and number) (1) Opportunities in Pharma, Biotech and Managed Care (DDPM-200R) (3) Pharmacotherapy and Diseases (DDPM-201R) (4) Pharmaceutics for Small Molecules and Macromolecules (DDPM-202R) (4) Pre-Clinical & Clinical Regulatory Submissions and Strategy (DDPM-203R) (4) Clinical Trial Development from Phase 0 to Phase 3 Studies (DDPM-204R) (4) Principles of Marketing Strategy, Product Value, and Life Cycle Management (DDPM-208R) (4) Biologics and Biosimilars Drug Development (DDPM-210R) (4) Managed Markets - Post Marketing Drug Utilization Management (DDPM- 211R) (4) Health Outcomes Evidence (DDPM-213R) (4) Business Development, Entrepreneurship, Corporate, and Intellectual Property Strategy (DDPM-214R) Comprehensive Exam No units of research may be applied to meet degree requirements.
2.3.5 Masters II Comprehensive Exam (Final Examination) Per UC San Diego Senate requirement 700-C, all students must pass a Master’s Examination to receive the degree. The 84-item examination will be administered at the end of the final quarter of study in the program. The exam will be in a written format, covering material presented throughout the program. Some case analysis and practice-based problem solving will be inserted in the exam to allow students to demonstrate their ability to integrate curriculum in an applied manner. All testing of students, remotely via online learning, will be done in the presence of a proctor (described in Section 2.13.3). The Steering Committee of the program (see 4.0 Faculty) will appoint an evaluation committee at the beginning of each academic year to construct exam questions and to conduct the student evaluation process. The committee created a rubric for scoring qualitative questions and apply the rubric in evaluating and grading each exam. The examination questions will be reviewed internally by the Managing Faculty Director, Program Faculty Director, and two full- time SSPPS faculty members who comprise of the MS in DDPM Steering Committee. Passing of this examination is required for graduation and degree conferral.
2.3.6 Licensing or certification requirements There are no licensing or certification requirements in connection with the program.
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2.4 Field Examinations No field examinations are required. 2.5 Qualifying Examinations No qualifying examinations are required.
2.6 Thesis or Dissertation No thesis nor dissertation required.
2.7 Final Examinations A final examination is required as described in section 2.3.2 and 2.3.5.
2.8 Special Requirements No special requirements over and above the Graduate Division minimum.
2.9 Relationship of master’s and doctor’s programs There is no duplication between the courses of the SSPPS PharmD degree and this degree program; they meet separate needs for separate student profiles.
2.10 Special preparation for careers in teaching As a professional, terminal degree program, there is no special preparation for careers in teaching.
2.11 Sample Program The program consists of 36 total units over three quarters, thus the normative time to complete the degree is one academic year. Each student is assigned a full-time load (12 units) of coursework each quarter. Students have access to the courses 24/7 and most of the course work (video lectures, readings, discussion forums) is done asynchronously. There will be some synchronous group discussions and project work, which will be scheduled in accordance to the with respective time zones and availability of the individual students. This overall flexible schedule allows students to maintain a job while pursuing the degree. The program and pace of study is provided in Appendix A of this document.
2.12 Normative Time from matriculation to degree The program is designed to be pursued full-time and completed in three consecutive academic quarters (Fall, Winter, Spring). We anticipate that most students will be career advancers working in some capacity while completing the program and the flexibility of the online format will help to accommodate these students’ schedules. Students may advance to candidacy and receive the degree only in their third (last) registered quarter in the program.
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2.13 Online Delivery The pharmaceutical and biotechnology industries conduct business across national boundaries and cultures as a matter of necessity, and recruits and selects professional talent accordingly. The program must attract promising individuals who are well versed and embedded in the cultures and professional nuances of the communities served by the pharmaceutical industry around the world. Highly desirable employees working for companies with global operations cannot easily leave their jobs or take on the financial burden of not only program tuition and fees but also living expenses in the San Diego region. Therefore, the ability for the program to extend its reachability is critical for meeting the educational needs of working professionals and for its overall sustainability and success.
2.13.1 Teaching and Learning Commons The MS in DDPM online program will be designed and implemented utilizing resources available through the Strategic Academic Program Development (SAPD) initiative. The Teaching and Learning Commons will support the MS in DDPM by providing expertise in curriculum design, student academic success and program assessment. Within the Teaching and Learning Commons, the Digital Learning team has experienced instructional designers who will assist the faculty in adapting the course curriculum to student centered online learning on our campus Learning Management System, Canvas, using the best pedagogical learning theories to ensure successful learning outcomes. Each online course will be administered on this system utilizing state-of-the-art technology supported by our Education Technology Services. Student teams will collaborate through the Canvas collaboration tools, while also utilizing integrated Slack channels and Google Drive.
Services provided by the Teaching + Learning Commons to support online learning include: Course and program development o Learning outcomes and curriculum mapping o Instructional design and digital pedagogy support o Quality Matters rubric review o Accessibility compliance review Course instruction o Training on LMS and digital technologies o Monitoring learning analytics for student engagement and performance Student support o Online student readiness: a self-paced tutorial to prepare students for success in online learning o Online orientation module: Intro to LMS, course structure, etc. students complete before start of program o Online tutoring support: content tutoring, learning strategies, writing support
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Course Assessment and Improvement o Providing data on student retention and performance, and student feedback on course and evaluation of IA and instructors o Using assessment data to iterate on course design
We consulted with the Director of Digital Learning at the Teaching and Learning Commons at UC San Diego. All online courses proposed and taught as part of this program will adhere to the following quality instructional practices. These practices reflect the research-based, Quality Matters standards for the design of high-quality online courses. https://digitallearning.ucsd.edu/_files/StandardsfromtheQMHigherEducationRubric. pdf. Course design and accessibility: o Course has clear structure, organization and navigation o Course objectives, assessments and activities are aligned o Course syllabus is learner-centered o Course design adheres to universal design standards o Course accessibility is addressed (i.e. videos are captioned, courses content and visual elements meet ADA standards) Learning Outcomes: o Course learning outcomes are clearly defined, measurable and stated in syllabus (or in the beginning of modules) o Course learning outcomes are aligned with program learning outcomes o All course learning outcomes are assessed o Instructional Materials: Instructional materials contribute to achieving the stated learning outcomes o A variety of instructional materials is used in the course o All activities and assignments have clear instructions on how to participate, when responses/submissions are due, and how the activities are assessed (e.g. clear rubrics) o Instructional materials and tools promote learner engagement and active learning o Instructor materials obey copyright laws Assessment: o Course grading policy is stated clearly at beginning of course o The assessments used are sequenced and varied and provide timely feedback o The course provides learners with multiple opportunities to track their learning progress o Academic integrity and plagiarism policies are clearly stated o High stake assessments are designed to achieve academic integrity Learner Interaction, Engagement, and Support: o The instructor’s plan for interacting with learners during the course is
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clearly stated o Instructor engages actively and frequently throughout the course o Learning activities provide multiple opportunities for student to student interactions that support active learning o The course instructions provide a clear description of the technical support available o The course instructions provide information about student services and institutional resources.
2.13.2 Technical support Educational Technology Services supports the instructional technology needs of UC San Diego faculty, staff and students. The following resources and services will support the online degree program:
The UCSD IT Service Desk (https://blink.ucsd.edu/technology/help- desk/service-desk) offers technical and EdTech support to the campus community via phone, email and in-person from 7 am – 10 pm weekdays and 12pm – 3 pm weekends. Hours may be expanded as online education expands. The EdTech Support team (https://edtech.ucsd.edu) provides dedicated expert support for instructors and support staff. Phone, email, and walk-in support is maintained from 8am-4:30pm weekdays. The team also offers regular 1:1 and group training for instructors. All support requests are logged, tracked, and managed via our IT Service Desk ticketing system (https://ucsdservicedesk.service-now.com/its). This ensures rapid response and solutions in a timely manner. Extensive self-serve documentation for EdTech needs is available 24/7 via the knowledge base (https://ucsdservicedesk.service-now.com/its?id=kb_view)
2.13.3 Accessibility for Students with Disabilities Partnering with the Teaching and Learning Commons’ instructional designers for online course design is critical for meeting the Electronic Accessibility standards established by UCOP (https://www.ucop.edu/electronic-accessibility/). The following accommodations for online learners, as recommended by the UC San Diego’s Office for Students with Disabilities, are already offered by UC San Diego’s Teaching and Learning Commons: The online program will meet the Electronic Accessibility standards established by UCOP https://www.ucop.edu/electronic-accessibility/ Program websites will refer prospective and current students to the UC San Diego Office for Students with Disabilities https://osd.ucsd.edu/ as a resource All videos will be captioned. This will not only accommodate students with hearing impairment, but also greatly help international students and those
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for whom English is a second language. Verbal descriptions will be provided to assist the visually impaired. For example, the lecturer will read aloud the mathematical equation being discussed. All videos will be screen reader accessible. Voice navigation and voice dictation will be available for those unable to type (accommodated upon request). For those with color blindness, the use of colors red and green will not be used to signify nor prompt priority or action The student will have the option to enlarge font size for online content All PDFs will be accessible
Additionally, the campus has adopted Quality Matters (QM) Standards as the benchmark for ensuring high quality online courses. Courses that meet QM Standards reflect critical design components that facilitate engagement and support student success. The Instructional Designers are certified in Quality Matters and accessibility and will work with the faculty to make sure each course is compliant.
2.13.4 Online Course Design Instructional Designers (IDs) from the TLC’s Digital Learning Hub will work in partnership with each course chair(s) to help them design and build the online courses. The term “course chair” and “instructor” may be used interchangeably to describe the role and responsibilities of an individual who serves in this capacity.
As is being done for the current in-person program, for the proposed online program, course chair(s), will provide oversight in the creation of course content, composing course goals and objectives, determining methods of student assessment(s), and the selection of lecturers to provide didactic, expert instruction. The course chair(s) is the subject matter expert and is responsible for the course content, assignments and assessments. Course chair(s) define what students consume and interact with during the course. With the exception of the Managing Director and Faculty Director, most faculty do not have experience teaching in the online modality. The IDs have expertise in pedagogical techniques and learning tools in an online setting and provide guidance to the faculty on how students will interact with and access their content. They will assist with the development of multimedia components, creating digital learning assets and building the course on the learning management system as needed. Throughout the instructional design process, each component will be aligned with learning outcomes and designed to provide faculty with analytical and anecdotal feedback that informs student performance and engagement. The IDs will also provide pedagogical and technical training for faculty and program staff on how to use the LMS and integrated technical tools when they teach their courses.
The course content will include the following components.
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Video lectures: Asynchronous - Recorded lectures by the faculty course chair(s) and guest lecturers who may incorporate PowerPoint presentations. All video lectures are closed-captioned. Formative assessment may be incorporated into video lectures. The lectures will be comprised of 5 to 10- minute segments, with polling questions following each segment. These polling questions will allow the student to gauge their understanding of the lectures as they proceed and offer the opportunity to revisit the lecture as needed. Each lecture will have a final quiz at the end to assess the student’s comprehension of the material presented. Readings: Students are assigned documents to review Discussions: Asynchronous – Students are prompted to engage in discussions regarding course content. Discussion threads are facilitated by faculty course chair(s). Automated formative quizzes: Ungraded short practice quizzes allow students to get feedback on their learning throughout the course, as well as polling questions that help students track their understanding of the lectures. Graded assessments: Exams and project work. Team projects: Synchronous -Students work in teams using virtual collaborative workspaces. Students present results of team projects to faculty course chair(s) during synchronous sessions. Peer review assignments: Students provide feedback on another student’s assignment often using an attached rubric. Video communication: Synchronous - Students engage in synchronous video communication with other students and with the faculty course chair(s). Video communications can also be recorded and shared.
2.13.5 Academic Integrity in Online Exams High stake assessments will be administered using ProctorU. ProctorU provides live and automated online proctoring services to ensure security of identity and exam integrity for online midterms and finals. ProctorU authenticates student’s identity using a photo ID through a webcam and requires a room scan of the test environment. During the exam, Proctor U monitors and records the student (through a webcam) and computer desktop (using desktop monitoring software) to catch any inappropriate physical or online activity. The course team specifies the rules (e.g. no phones, no calculators, no visiting websites, etc.). ProctorU reports any suspicious activity to the instructor to make the final integrity decision.
2.13.6 Student Advising Starting an online degree program can be intimidating to students who are new to the online modality and unfamiliar with current technology, virtual communication and independent, self-motivating learning. Digital Learning has developed an online readiness self-assessment that students will take upon acceptance to the online degree program. This self-assessment will provide strategies and information on how
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to get technical support, how to build an online learning network and effective study habits in an online environment. Additionally, upon admittance to the degree program, students will get access to a short online orientation course which will welcome them to the program, provide information about the instructors and program support staff and allow them to introduce themselves to their classmates. The orientation course will also provide an overview of the Canvas Learning Management platform and the structure of program.
Academic advising is critical to student success. The program will maintain a ratio of one advisor to twelve students. As the program approaches the planned “steady state” enrollment level of 110 students, at least 10 advisors will be needed to maintain this ratio, and we currently have 16 active advisors. Suitable university as well as industry advisors will be recruited and compensated to assist the program’s core faculty advising team in this important function.
During orientation, students will be assigned an academic advisor based on their academic and career goals and will interact with their advisor throughout their course of study in the program. Academic advising will consist of periodic conversations with each student via a combination of email and desktop teleconferencing tools (e.g., Google Hangout, FaceTime, GoToMeeting, ZOOM). In addition to these forums, the program will explore software that allows real-time participation and communication for interaction between faculty and students. Basecamp and Microsoft Team are other technologies for online collaboration. Advisors will be guided in conducting these interviews through assessment rubrics, checklists, and student achievement data provided by program directors in order to track student progress and identify any performance concerns.
In addition, the introductory course, DDPM-200R - Opportunities in Pharma, Biotech and Managed Care focuses on understanding the pharmaceutical, biotechnology and managed care landscape at a strategic level by examining many of the emergent topics facing the medical industry today. Each week students will learn skills that are required to have a successful career in the pharmaceutical, biotech and managed care industry, and develop a personal Strategic & Tactical Career Plan (STCP). Advisors will refer to the student’s individual STCP during advising sessions to help guide the student through the program and to help them consider career options.
The online courses will be designed with multiple opportunities for students to collaborate and support each other, as well as connect with the instructor and degree coordinator. The discussion forums will be monitored by the instructors on a regular basis to catch any difficulties or confusion students are sharing regarding the course content.
Administrative advising will be provided by UC San Diego Extension under the direction of SSPPS. The Graduate Coordinator supports student services and is a
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liaison with various UC San Diego departments, including Graduate Division, Student Billing Services, Financial Aid and the International Students & Programs Offices. Should a student require a refund or decide to withdraw from the program, the Graduate Coordinator will provide assistance.
2.13.7 Learning Analytics and Assessment The LMS provides robust data on student progress and engagement with course materials. Instructors are able to track in real time how students are performing and demonstrating their learning. Additionally, the built-in gradebook helps instructors assess student learning in relation to the course learning outcomes. Instructors can use the data to track student progress and to discuss during their Zoom office hours and/or one on one meetings with students.
Tracking student performance of each course is the responsibility of the faculty course chair(s) and includes multiple methods of assessment, including but not limited to quizzes, midterms and/or final examinations, case-based study review, group presentations, and individual presentations. Successful completion of each course will be recorded as graded coursework and completed credit units on the student’s academic transcripts. Every course in the program requires the letter grade option so students maintain a GPA, and the program will adhere to a minimum GPA of 3.0 (Graduate Division policy).
3 Projected Need 3.1 Market assessment During the fall of 2018, the UC San Diego Center for Research on the Regional Economy performed an assessment of the market for a program such as the one being proposed. The assessment includes a review of government projections for job opportunities in this field, examination of comparable or substitute programs of study, surveys and interviews with potential students and employers, and an analysis of the probable return on educational investment for individuals who complete the program. The complete assessment is included in Appendix B of this document.
The assessment’s key findings are as follows:
The proposed online MS in DDPM is geared towards individuals who need to have managerial, regulatory, clinical, marketing, post market utilization, and legal knowledge regarding the drug development process. This program is intended for experienced professionals with a bachelor’s degree and/or advanced degrees to gain managerial and collaborative skills in order to effectively monitor the multiple facets of the drug product development process from “bench to bedside” in the workplace.
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Based on data from comparable programs and survey responses, the MS in DDPM leadership plans to target potential students who are looking at advancing within their careers. Most comparable programs prefer students to have 2 to 5 years of professional experience. Additionally, university leadership may want to focus on recruiting students from a specific industry. The following report provides an analysis of three potential industry segments: 1) Life Sciences and Biotechnology, 2) Pharmaceutical and 3) general health industry segments. Students will likely enroll from all three industry segments, however, by focusing on a specific industry the MS in DDPM leadership can ensure that the target student population’s educational programmatic preferences are addressed.
Comparable programs range from 18 months to 2 years of instruction, with the vast majority being 2 years in length. Students’ preferences were evenly split in terms of their preference for a 1- or 2-year program model. However, the preferred program length did vary when looking at students employed in specific industries.
The Return on Investment (ROI) for career advancers varied depending on the program length. Regardless, both the one- or two-year program models provided a reasonable ROI within the next ten years of a student’s career.
Overall, moving forward with the MS in Science in DDPM appears to be a viable option in terms of employer and student appeal. The majority of employers found the degree would be useful or very useful. Similarly, the majority of potential students also expressed finding the degree appealing or “maybe” finding it appealing, with very few individuals not finding it appealing. Based on this research, in the United States there are eight comparable master’s programs that exist proving that there is a market for this degree.
In addition to the market assessment, a number of industry leaders have been consulted regarding the proposed program. They have heartily given their endorsement of the concept and effort. Specific letters of endorsement from many of these individuals can be found in Appendix F of this document.
The MS in DDPM program will potentially have a competitive edge over other current drug development graduate programs. First, students will have the opportunity to complete the program in one year, compared to 18 to 24 months with other programs. The flexibility of online learning will make the program competitive, especially for students want to continue working while pursuing the degree. Second, only Rutgers University’s Clinical Trial Science program is online focused at this date, although there is a rapidly growing trend of top-tier universities (e.g. Harvard, MIT, UC Berkeley, etc.) offering other degree programs online. Third, the additional competitive edge of the MS in DDPM program will be its early position in offering the MS degree via online. Moreover, the reputation and prestige of UC San Diego and its Health Sciences department are internationally recognized. Fourth, this program will
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have been executed based on learnings from the face-to-face version of the program. Finally, this MS in DDPM program will be using speakers from multiple companies reinforcing to a global audience UC San Diego’s place as a collaborator with multiple pharmaceutical, biotechnology and managed care stakeholders in drug development.
3.2 Placement estimates, and enrollment projections The prestige of UC San Diego, in particular the globally renowned Health Sciences, makes the MS in DDPM degree highly desirable to international employers. Employers recognize UC San Diego as one of the top research and teaching universities in the world, and a degree from UC San Diego will greatly enhance the students’ ability to secure upward mobility by being hired in a new firm and/or being promoted within their existing organization. As employers increasingly are seeking employees trained across disciplines, the interdisciplinary nature of the MS in DDPM program provides strong confidence that students will find career placement upon completion of the program.
Regarding program enrollment projections, based on the initial market assessment and the strength of anticipated student placement, the program is confident it can obtain 65 new students the first year providing we have a lead-time of 6 to 9 months for marketing the program. The program will slowly expand during the stabilization phase, and cap at 110 students annually. Projections for global online format enrollment is outlined in Table 1.
Table 1: Projected Enrollment through Year Five (Steady State)
Cohort Year 1 Year 2 Year 3 Year 4 Year 5 Total/FTE Students 65 75 110 110 110
The flexibility of taking courses online allows students to remain in full-time employment, even if their work requires traveling. The mix of online students is anticipated to be local students, students from outside the region, including both U.S. and international. We anticipate a significant international demand for the online MS in DDPM degree program. Analysis of current application numbers for the residential MS in DDPM currently offered shows that 77% of prospective student inquiries are from outside the United States, predominantly from countries in Asia, Latin America as well as Africa.
We will select the most qualified students, regardless of where they come from, for the online program. However, given the experience in similar UC San Diego Extension programs and our experience with offering courses through Coursera, we expect at least one third of online students to be international. Local students may find the online format preferable in accommodating a full-time or part-time work schedule. We expect the international applicant pool to include candidates
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primarily from Europe and Asia based on the predominance of drug development activities in these regions.
4 Faculty The program relies upon a combination of current clinical and adjunct faculty, supplemented by rotating speakers from industry. The anticipated course coordination load for existing faculty will be modest (one to two courses per year in most cases), so that it will not negatively impact current duties, but specific statements from many of the faculty regarding the impact of this program on their overall workload are included with their CV in AppendixJ of this document. The term “course chair” and “instructor” may be used interchangeably to describe the role and responsibilities of an individual who serves in this capacity. We note the suggestion to ensure instructional guidelines and labor regulations are in compliance with duty allocation and terminology. The SSPPS committee on educational policy has approved the program (letter in Appendix F).
The Managing Director and Faculty Director for this proposed degree program have experience offering online courses. Since September 2016, Professors Ettouati and Ma have offered courses on Drug Development, Drug Discovery, and Drug Commercialization on the Coursera platform. These course information sites were visited by nearly 170,000 prospective students, with more than 40,000 enrolling in the online courses. All faculty involved in the online degree program will receive training from the Teaching + Learning Commons on effective pedagogical methods for online instruction and technical training on the use of the Canvas Learning Management System. The faculty will also have access to Digital Learning’s Guide to Online Teaching – a series of self-paced, online modules on a plethora of topics, including how to effectively engage students, creating inclusive communities, academic integrity, assessing student learning, and much more.
All faculty participation in the program will be funded directly from the program. The program budget also includes support for assistance to a course coordinator.
The curriculum vitae of each faculty member committed to participate in the program can be found in Appendix K of this document (separate file).
4.1 Steering Committee The MS in DDPM Faculty Steering Committee is responsible for reviewing applications, interviewing candidates, and nominating qualified candidates to the Graduate Division for admission. Faculty course chair(s), with oversight from the steering committee, will be responsible for creation of course content, composing course goals and objectives, determining methods of student assessment(s), and the selection of lecturers to provide didactic, expert instruction.
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The following individuals will serve as Steering Committee members, overseeing all elements of the curriculum, faculty selection and performance, student advising, admissions and industry relations. They will also coordinate courses, teach, serve on the admissions committee, and advise students. Members of the Steering Committee serve for a three-year term, which may be repeated. They are appointed by the Dean of the SSPPS.
Joseph D. Ma, PharmD Faculty Director Professor of Clinical Pharmacy UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS)
Dr. Ma’s role in the program as the Faculty Director will be to provide oversight of faculty selection and performance, as well as academic policy and decisions, including student evaluation. In addition, he co-teaches a course in clinical development and co-chairs a course in Biologics and Biosimilar development. Dr. Ma is a Professor of Clinical Pharmacy in UC San Diego’s SSPPS. He received his undergraduate degree from UC Irvine, his Pharmacy Doctorate from UC San Francisco, and completed a post- doctoral fellowship in clinical pharmacology at Bassett Healthcare, Cooperstown, NY.
His current research interests are evaluating in vivo drug metabolizing enzyme activity and opioid pharmacokinetic variability. He has published over 60 peer- reviewed articles and is coeditor of a textbook Pharmacogenomics, An Introduction and Clinical Perspective. His current clinical practice is the Doris A. Howell Pain and Palliative Care Service at the UC San Diego Moore’s Cancer Center, where he specializes in symptom management. Under a collaborative practice agreement, he is able to assess, initiate, stop, and/or adjust therapy for the management of pain and other physical symptoms with independent prescriptive authority in accordance with California code 4052. Prior to joining UC San Diego, Dr. Ma worked at Amgen in early clinical trial development where he was responsible to help develop drugs to IND and manage proof of concept clinical trials.
Williams S. Ettouati, PharmD Managing Director, Associate Clinical Professor UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS)
Dr. Ettouati’s role in the program as the Managing Director will be supervising day-to- day operations (including program related student interactions) and recruiting student mentors. He will be the primary contact with industry advisors and employers. In addition, he teaches three courses: one four-unit course in pharmaceutical marketing and product management, one one-unit course in business development and entrepreneurship, and one two-unit course in career planning.
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Dr. Ettouati is currently Director, Strategic Academic Program Development Support Team, Director, Industry Relations and Development and Health Sciences Associate Clinical Professor at the SSPPS at the University of California San Diego. Dr. Ettouati’s role as Director Strategic Academic Program Development Support Team is to work with faculty across UC San Diego and help create novel educational programs. Dr. Ettouati's role at the Skaggs School of Pharmacy and in the Health Science School of Medicine is to develop and secure strategic collaborations, ranging from drug discovery to corporate sponsored fellowships for PharmD students with pharmaceutical and biotechnology companies.
Before joining the SSPPS, Dr. Ettouati spent twenty years in the pharmaceutical and biotechnology industry in senior leadership roles (e.g. CEO, President & Co-Founder, Director, Chief Business Officer). Dr. Ettouati has proven and extensive experience encompassing multiple functional disciplines in pharmaceutical executive management, in areas such as business development, licensing, marketing and new product planning strategy in biotech and pharmaceutical companies.
Jeremiah Momper, PharmD, PhD Associate Professor of Clinical Pharmacy UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS)
Dr. Momper will participate in academic policy decisions and matters of program marketing and design strategy as a key member of the program steering committee. He will also teach classes in regulatory sciences.
Currently, he is Assistant Professor of Clinical Pharmacy in SSPPS where his research is focused on mechanistically understanding alterations in drug disposition and response in special populations. Studies investigating pharmacokinetic- pharmacodynamic relationships of antiviral nucleotide analogs in transplant recipients with opportunistic infections are ongoing. In addition, Dr. Momper is pursuing the application of novel clinical pharmacology tools, such as physiologically based pharmacokinetic modeling, to support scientific decision making during pediatric drug development. Prior to joining UC San Diego, Dr. Momper worked at the FDA and completed the Commissioner’s Fellowship Program (2011 – 2013) at the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Felix K. Yam, PharmD, MAS, BCPS, BCCP Associate Clinical Professor of Pharmacy UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS)
Felix K. Yam, PharmD, MAS, BCPS, BCCP is an Associate Clinical Professor at UC San Diego’s SSPPS. He received his PharmD degree at the University of Rhode Island College of Pharmacy and Master of Advanced Studies (MAS) in Clinical Research at
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UC San Diego. He completed post-graduate residency training programs at the University of Kentucky and Cedars-Sinai Medical Center. Dr. Yam was a recipient of the American Foundation for Pharmaceutical Education (AFPE) Fellowship Award in Pharmacotherapy. He holds board certification in pharmacotherapy and cardiology.
Dr. Yam is a clinical pharmacy specialist in cardiovascular disease and internal medicine. His clinical practice is at the Veterans Affairs hospital in San Diego where he cares for patients with complex cardiovascular disorders including heart failure, hypertension, hyperlipidemia and atrial fibrillation. At the School of Pharmacy, Dr. Yam is the Director for Advanced Pharmacy Practice Experiences and he teaches in the cardiovascular therapeutics course for third year pharmacy students.
His primary research interests include investigations into novel therapies for heart failure and evaluating the use of remote monitoring technologies to improve patient outcomes. He is a principal investigator on studies evaluating medication regimen complexity, medication adherence and the impact of multidisciplinary care models on improving outcomes in patients with heart failure. He is an active co-investigator on industry sponsored clinical trials evaluating novel heart failure treatments.
4.2 Core Faculty The following individuals will coordinate courses in the program, teach, serve on the admissions committee, and may serve as student advisors.
Brookie Best, PharmD, MAS Professor of Clinical Pharmacy and Pediatrics Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) and Department of Pediatrics, UC San Diego-Rady Children’s Hospital San Diego
Dr. Best’s role in the program will be to teach or co-teach a course in Pharmaceutics for Small Molecules and Macromolecules, and to give lectures in areas related to her expertise in Phase 1 and 2 clinical studies, pharmacokinetics, and designing dosing regimens in various patient populations, including infants, children, non- pregnant adults, and pregnant and lactating women. She is a Professor of Clinical Pharmacy and Pediatrics and the Associate Dean for Pharmacy Education at UC San Diego’s SSPPS, and the Department of Pediatrics, School of Medicine (SOM)-Rady Children’s Hospital San Diego. She completed a Bachelor of Science degree at UC San Diego in Chemistry with an Emphasis in Chemical Education. She received her PharmD degree from UC San Francisco and completed residency training in Pharmacy Practice at the UC San Diego Medical Center. Dr. Best was an NICHD/NIH Fellowship recipient in Pediatric Clinical Pharmacology Research and completed a Master of Advanced Studies (MAS) in Clinical Research at UC San Diego.
Dr. Best specializes in pharmacokinetics – the processes by which a drug is absorbed, distributed, metabolized and eliminated by the body – and
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maternal/fetal and pediatric clinical pharmacology research. Her research efforts have focused on studying anti-HIV drugs in pregnant women, children and non- pregnant adults. She also studies drugs used to treat Kawasaki disease, the leading cause of acquired heart disease in children. She has specific interests and expertise in maternal-fetal clinical pharmacology, therapeutic drug monitoring of antiretrovirals, and penetration of antiretrovirals into the central nervous system. Dr. Best’s research program encompasses projects with key statewide, national and international HIV/AIDS and pediatric pharmacology collaborative research networks.
Hubert C. Chen, MD Chief Medical Officer, Metacrine Inc. and Medical & Scientific Advisor, Pfenex Inc.
Dr. Chen will co-teach the course in Biologics and BioSimilars Drug Development. Dr. Chen is a Physician-scientist with 12 years of research & development experience in multiple therapeutic areas in the biotech industry, and six years of basic research, clinical care, and teaching experience in academia. Dr. Chen’s experience as an executive at Amgen and in start-up enterprises demonstrated proven ability to work in a fast-paced, matrix environment, both as a strategic leader and a “roll-up-the- sleeves” tactician. Dr. Chen led and supervised multiple projects through key stages of research and development, including target selection (two programs), clinical candidate nomination (seven), IND submission (nine), clinical proof-of-concept (four), and phase 3 start-up (two). Dr. Chen is Board certified in both Internal Medicine and Endocrinology, Diabetes & Metabolism. Dr. Chen is currently Chief Medical Officer at Pfenex Inc.
Raphael Cuomo, PhD, MPH, CPH, FRSPH Research Scientist, UC San Diego
Dr. Raphael E. Cuomo, PhD, MPH, CPH, FRSPH is a public health scientist and academic administrator. He has published numerous academic papers in leading biomedical journals, and he is the recipient of several awards for his scientific contributions. Dr. Cuomo has completed training with the World Health Organization, Harvard University, and Yale University. Dr. Cuomo is board certified in public health by the US-based National Board of Public Health Examiners, and he is a Fellow of the UK-based Royal Society for Public Health. He has also been an active member of several professional public health organizations, including the American Public Health Association, the American College of Healthcare Executives, and Academy Health.
Dilesh Doshi, PharmD Senior Director, Population Health Research, Janssen Scientific Affairs
Dilesh Doshi, PharmD has over 20 years of experience in the pharmaceutical industry
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as a Health Economist. Dilesh has a Bachelor of Science in Chemistry from Central Connecticut State University and a Doctor of Pharmacy degree from University of California, San Francisco. He has completed a 2-year postgraduate fellowship in health economics at Thomas Jefferson University in Philadelphia, PA. He has worked in Global and US Health Economics & Outcomes Research groups at SmithKline Beecham, AstraZeneca, and Johnson & Johnson. He also holds a voluntary faculty appointment as Assistant Clinical Professor in the SSPPS at the University of California, San Diego. Currently, Dilesh is the Senior Director for Population Health Research at Janssen Scientific Affairs.
Dilesh has been recognized nationally as a subject matter expert in health economics as evidenced by invited speaking engagements at National and International conferences such as BIO 2017 and World Congress Population Health Summit. He has over 70 conference presentations and peer reviewed publications including book chapters, manuscripts, white papers, and posters. He is also a member of several external organizations that shape the future of healthcare such as the Accountable Care Learning Collaborative and the Health Management Academy’s Population Health Collaborative.
William M. Evans, JD Director, Patents, Ionis Pharmaceuticals, Inc.
William M. Evans, JD has been a Director of Patents at Ionis Pharmaceuticals in Carlsbad since 2011. He is responsible for drafting and prosecuting patent applications relating to antisense compounds, nucleotide purification and synthesis, and siRNA compounds. He manages an extensive worldwide patent portfolio. He negotiates and drafts license agreements, MTAs, and CDAs, along with managing post-grant proceedings in the U.S. and Europe. He prepares Orange Book listings and analyzes patent term extension for FDA approved products. He performs freedom to operate and patent landscape searches and provides guidance on company policy related to electronic notebook maintenance and record keeping.
William completed a joint BS in Chemistry/BA in History, as well as a MS in Chemistry at UC San Diego, and earned his law degree from the University of San Diego.
Caroline Forrester, PharmD Clinical Specialist, MedImpact Healthcare Systems Dr. Caroline Forrester is Clinical Pharmacist the Managed Care/Pharmacy Benefit Management Industry. She has experience in Drug Information, Drug Utilization Analysis, Formulary Strategy and Management, Pharmacy and Therapeutics Support, and Prior Authorization review. Dr. Forrester completed a PGY-1 Managed Care Pharmacy Residency at OptumRx and is currently a Clinical Specialist at MedImpact Healthcare Systems. Her therapeutic areas of interest include autoimmune biologics and biosimilars.
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Katie Lyons, PharmD President, Trajet Consulting, Inc.
Katie Lyons, PharmD has over 20-years of experience within or around academia and the pharmaceutical industry. Dr. Lyon’s academic experience includes research, full- time, part-time, adjunct and lecture faculty positions. Her experience in the pharmaceutical industry with Amgen and other biotech companies spans both Medical Affairs and Regulatory Affairs. It encompasses experience as a Medical Liaison within Medical Communications and Promotional Regulatory. Currently, Dr. Lyons is President with Trajet Consulting, Inc., a Medical and Promotional Regulatory Consulting Firm that strives to provide strategic-minded solutions that consider the regulatory environment while meeting the business objective.
Cindy Evans Nguyen, JD, PharmD Attorney, Pharmacist, UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS)
Cindy Evans Nguyen, Esq. is a California licensed attorney and legal consultant to companies in the biotechnology, healthcare, and pharmaceutical industries. She began her career as an intellectual property attorney counseling clients in a wide variety of trademark, copyright, and patent matters. She has also served as in-house legal counsel for Cytori Therapeutics and Intercept Pharmaceuticals, providing counsel in contract negotiation, corporate governance, clinical trial development, regulatory compliance, medical affairs, product development, and intellectual property licensing. She has lectured on intellectual property protection and pharmacy law and ethics at UCLA School of Law and at UC San Diego School of Pharmacy.
Cindy completed her undergraduate degree at Harvard University and earned her law degree from the University of California Los Angeles School of Law. She received her Doctor of Pharmacy degree at the UC San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences.
Chantal Reed, PhD Assistant Clinical Professor UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) Director, CMC Project Management, Gossamer Bio
Dr. Reed’s role in the program will be to teach or co-teach a course in Pharmaceutics for small molecules and macromolecules and to give lectures in areas related to her expertise.
Dr. Reed has a PhD in Bioengineering and is currently a pharmaceutical executive and
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volunteer faculty at SSPPS. Her research focused on the complexation of synthetic, pH-responsive polymers with proteins in order to enhance the endosomal release of targeted biomolecules, thereby increasing their therapeutic efficacy in the area of drug delivery and product quality for antisense oligonucleotides, small molecule.
While working with biotech companies, her responsibilities included developing novel formulation research to qualify new dosage forms appropriate for specific therapeutic indications and routes of administration. She focused on novel (liposomal and polymeric) dosage forms, aseptically prepared parenteral solutions and nasal sprays. She designed and led animal studies to ascertain the effectiveness of novel formulations. In addition, her responsibilities included optimizing transfection conditions in new and difficult cell types, including primary cells, investigating cell- type specific parameters which affect the efficiency of in vitro transfection.
Niels Vande Casteele, PharmD, PhD Assistant Professor, UC San Diego School of Medicine, Department of Medicine
Dr. Vande Casteele obtained his Bachelor of Science in Pharmaceutical Sciences and Master of Science in Drug Design and Development at the University of Leuven, Belgium. He performed research in the field of Molecular Biology at the Institute of Medical Sciences, University of Aberdeen, Scotland and in the field of Immunology at Sanquin, University of Amsterdam, the Netherlands. He obtained his PhD in Pharmaceutical Sciences entitled “Optimizing anti-TNF therapy in inflammatory bowel disease patients, a step towards personalized dosing” at the University of Leuven, Belgium. After completing a postdoctoral fellowship, he was appointed as a faculty member of the School of Medicine at the University of California, San Diego. His research efforts focus on clinical pharmacology of biologics used in the treatment of chronic inflammatory diseases, with an emphasis on bioanalytical method development, therapeutic drug and immunogenicity monitoring in relation to treatment outcomes, and clinical drug development.
Dr. Vande Casteele also holds a position of Director, Precision Medicine at Robarts Clinical Trials, Inc. where he oversees the development, validation and operationalization of clinical and translational research tools to support sponsor- and investigator-initiated studies to ascertain efficient (early phase) drug development.
Dr. Vande Casteele has published over 50 peer reviewed research articles and book chapters, and has received awards for his research contributions from distinguished professional organizations such as the European Crohn’s and Colitis Organization (ECCO), the American Gastroenterological Association (AGA), the Belgian American Educational Foundation (BAEF), the Flemish Association of Gastroenterology and United European Gastroenterology (UEG) association.
Farrah Wong, PharmD
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Farrah Wong, Senior Director, Commercial Formulary Contracting Strategy, OptumRx
Dr. Wong is senior director of Commercial Formulary Contracting Strategy at OptumRx, one of the largest pharmacy benefit managers in the United States. Her primary responsibilities include formulary management and strategy, forecasting, and trend assessment. These initiatives drive the development and implementation of effective strategies that focus on clinically sound and affordability measures.
Dr. Wong has over 10 years of experience as a pharmacist in the managed care and clinical setting. She earned her PharmD degree from the University of Southern California and BS degree from the University of California, Los Angeles.
4.3 Voluntary Faculty SSPPS Voluntary Faculty (VF) are appointed and monitored by SSPPS. Individuals who provide significant teaching by way of chairing or co-chairing a course to our students are eligible for a voluntary faculty appointment at SSPPS. With the exception of a single course (DDPM211 Managed Markets, Post Marketing, Drug Utilization Management), all MS in DDPM courses involve a UC San Diego faculty member as either chair or co-chair, with whom Voluntary Faculty will work. Individuals must be teaching students within the next 12 months to qualify for a Voluntary Faculty appointment. Applicants complete an appointment request form and provide an updated CV or resume. The application materials are reviewed and approved by a SSPPS Faculty committee. If approved, the duration of the appointment is for a period of 3 years. Afterward, the individual must reapply and undergo the same process of submitting application documents to be reviewed and accepted by SSPPS faculty.
The term “Voluntary Faculty” is formal terminology utilized by UC San Diego Health Sciences for the Skaggs School of Pharmacy & Pharmaceutical Sciences (SSPPS) and the School of Medicine as per the UC San Diego Policy and Procedure Manual (PPM) 230-279 (http://adminrecords.ucsd.edu/PPM/docs/230-279.html). An appointee must have a doctorate in a clinical discipline. Since our MS in DDPM includes individuals with a Medical Doctorate, Pharmacy Doctorate, and/or Doctor of Philosophy in the healthcare/medical field, utilization of PPM 230-279 was selected. Furthermore, the UC San Diego SSPPS has further differentiated within the Voluntary Faculty Appointment either an Affiliate Faculty appointment or a Non-Salaried appointment (https://pharmacy.ucsd.edu/sites/pharmacy.ucsd.edu/files/docs/faculty- residents/Volunteer-Process-FAQ%20(1).pdf).
The MS in DDPM VF are involved as course chairs or co-chairs in designing courses to reflect the needs of the Pharmaceutical, Biotechnology and Managed Care industries and are a vital part of creating a highly innovative educational program. Our VF work in synergy with our Core SSPPS Faculty to define student learning objectives, develop
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related student assessment strategies, and provide teaching and learning activities.
Our MS in DDPM VF are MDs, PharmDs, and PhDs who are healthcare professionals or professional executives with years of work experience in industry. They provide not only real-world drug development and management practical expertise, but in addition, provide networking opportunities to our students. Our VF engagement may also provide career guidance and student mentoring. VF in this program bring critical contributions to teaching and learning of our students. Our VF are an integral part of MS in DDPM program and help create an exceptional culture for student success.
Individuals who are not employees of UC San Diego and who provide significant teaching by way of serving as course chair are eligible for the SSPPS Affiliate Faculty appointment. For the MS in DDPM, course chairs are required to obtain an SSPPS Affiliate Faculty appointment. Invited guest speakers who provide didactic instruction in a specific course (and who have no course chair responsibilities) have the option to apply for an Affiliate Faculty Appointment within SSPPS.
5 Courses The full list of courses outlined in section 2.3.4 that will be taught in the program follows. All of the courses listed have been developed for the classroom-based program and will need to be developed for the online platform specifically for this program. The listing indicates the course coordinator and details regarding the content of the course. Parameters regarding course length, units of credit, etc. can be found in the Academic Senate course approval requests included in Appendix D of this document.
The curriculum has been developed to focus on drug development and product management. For example, animal toxicity studies for Good Operating Practices (GOP) and Good Manufacturing Practices (GMP) are highlighted in the regulatory course since these studies are part of an IND filing. Supply chain and product quality management will be covered briefly, noting that the program is not purely focused on manufacturing. Pre-clinical pharmacokinetics and pharmacodynamics (PK/PK) studies are covered in the regulatory course as these are part of an Investigational New Drug (IND) filing. In addition, the Clinical Development course will cover clinical PK/PD.
In addition, because the program is self-funded, state tuition payments are not applied. Consequently, although courses in the program are open to any admitted UC San Diego graduate student, separate fees must be assessed to that student (or a sponsoring department).
DDPM-200R - Opportunities in Pharma, Biotech and Managed Care (Ettouati, W.) The Introduction: Opportunities in Pharma, Biotech, and Managed Care course is a fall quarter, one unit course focusing on understanding the pharmaceutical,
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biotechnology and managed care landscape at a strategic level, examining many of the hot topics facing the medical industry today. Each week students will learn skills that are required to have a successful career in the pharmaceutical, biotech and managed care industry. To familiarize students with the scope of issues and decisions that managers in pharma, biotechnology, and managed care face as their companies progress, professionals and executives from these industries will talk about their background, how they got to where they are today in their careers, and challenges they face in the current industry environment.
Course Objectives: Introduce critical skill sets that are essential for success within this industry Provide an overview of a broad range of post MS career opportunities Develop a personal Strategic & Tactical Career Plan (STCP)
Students will learn and hear from industry executives about the wide range of career opportunities that exist from clinical trials to managed markets. In addition, the course will introduce skill sets that will form a foundation for students to apply and hone throughout the curriculum.
DDPM 201R Pharmacotherapy and Diseases (Yam, F) This course will provide students an introduction to the pathophysiology and pharmacotherapy of the most common chronic human diseases. The course is designed to introduce pharmacotherapy concepts to students with a wide variety of academic and health science backgrounds. An emphasis will be placed on discussing therapeutic challenges encountered by healthcare providers and patients in the real- world setting. The goal of this course is to provide students with a body of knowledge that enables them to consider real-world therapeutic challenges when participating in the drug discovery process.
Course Objectives: Describe the pathophysiology of select human diseases (e.g. neurologic, cardiovascular, cancer, pulmonary, endocrine, infectious diseases, and autoimmune disorders). Understand how pharmacologic therapy is used to achieve the desired therapeutic goals and health outcomes for common conditions. Describe the current treatment gaps and barriers to achieving optimal health outcomes for select human diseases. Identify common therapeutic challenges encountered when treating human disease (e.g. side effects of drugs, impact of pharmacogenetics on response to drugs, non-adherence to drug therapy). Apply knowledge of pathophysiology and pharmacotherapy to the drug discovery process (e.g. drug development, clinical trial design, post-marketing surveillance, and product management).
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DDPM-202R - Pharmaceutics for Small Molecules and Macromolecules (Best, B., Reed, C.) This course examines the tools used to assess the systemic bioavailability of drugs, delineates the processes determining drug absorption, summarizes the physicochemical properties of a drug, and presents pharmacokinetic principles used to predict the time course of a drug.
Course Objectives: Examine the systemic bioavailability of drugs following various routes of administration and the bioequivalence of drug products. Delineate the physiologic processes determining the rate and extent of drug absorption. Summarize the physicochemical properties of a drug and the formulation factors influencing the rate and extent of drug absorption. Present the pharmacokinetic principles used to summarize and predict the time course of drug in the body. Understand the process used by companies to take a newly identified drug candidate to a commercial product pre-formulation, excipients, manufacturing, and packaging. Be able to evaluate and select an appropriate dosage form, including: understanding the chemical, physical chemical and physiologic, barriers that must be considered in the design of the dosage form, understanding the processes used to manufacture the dosage forms, being aware of the critical factors associated with the integrity of dosage forms. Become familiar with devices and formulations being used to effectively administer drugs.
DDPM-203R - Pre-Clinical and Clinical Regulatory Submissions and Strategy (Momper, J) This course provides an overview of the common regulatory filings during pre-clinical and clinical development. Using a case study format, the student will gain an understanding of the regulations governing pharmaceutical and biologic products in the United States and globally. This course provides an overview of the common regulatory filings during pre-clinical and clinical development, including Investigational New Drug Applications and New Drug Applications. Students will gain an understanding of the regulations governing pharmaceutical and biologic products in the United States and globally. The process of writing multidisciplinary reports and submissions to regulatory agencies is reviewed. Generic drug regulation is also covered.
Course Objectives: Describe the timeline of regulatory submissions to move drug products and
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biologics toward approval. Examine key elements for successful regulatory filings, including INDs, BLAs, NDAs, sDNAs. Understand the role of project managers and other regulatory professionals in the drug development process. Describe interactions with regulatory agencies during drug development in the United States and abroad. Understand rules and regulations pertaining to advertising and promotion. Understand harmonization of the drug development process from a global perspective.
DDPM-204R - Clinical Trial Development from Phase 0 to Phase 3 Studies (Ma, J.) Students will learn the process of drug development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market. At the completion of this course, the students will be able to have a better understanding of early stage clinical drug development. Students will learn the process of drug development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market. It also includes legal and ethical regulations that apply to drug development.
Course Objectives: Provide an understanding of all the stages of drug development clinical trials such as Phase 0, Phase 1, drug-drug interaction, drug-food interaction, and bioequivalence trials. Identify outcomes and/or endpoints differences between a Phase 0 Phase 1 vs. drug-drug interaction vs. bioequivalence trial. Incorporate study design methods for consideration in the design of clinical protocols to access safety, tolerability, and efficacy in multiple therapeutic areas. Understand the challenges and bias related to the conduct of clinical research and/or clinical trials. Develop clinical plan from POC trials Phase 2 to pivotal trial Phase 3
DDPM-208R - Principles of Marketing Strategy, Product Value, and Life Cycle Management (Ettouati, W., Lyons, K. and Doshi, D.) This course will provide an overview of pharmaceutical marketing and principles for cost-effective analysis. The marketing section of the course will cover the marketing mix considerations; strategies for gathering customer insights through market research; how marketing has evolved from a linear system to an interconnected system; interaction and considerations for marketing with other internal departments or external agencies. The principles for cost-effective analysis section of the course will cover the types of analyses necessary to develop a body of evidence to demonstrate product value through understanding of analysis types, critique of
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cost-effectiveness evidence and conducting cost-effectiveness analysis.
Course Goals & Objectives: Students will engage with speakers on a wide range of marketing and cost- effectiveness strategies utilized in the pharmaceutical industry. Students will be introduced to form a foundation for students to apply in a career within either marketing or health economics. By the end of the course, students will be able to identify and have developed key skills related to: What pharmaceutical marketing means in today’s environment? Provide an in-depth understanding of purpose and development of a marketing strategy Understanding of key market research principles and practices and learn to analyzing markets and develop relevant strategy The role of brands and how to build them Utilizing key strategic tools Identifying a product differential position Understanding of the role and power of segmentation Driving successful strategy implementation Evaluating marketing effectiveness Learn the importance of Portfolio Management, as well as life cycle strategic plan to maximize product revenue Prepare a drug marketing plan and implementation mix Conducting cost effectiveness analysis Assessing the strengths and weaknesses of cost-effectiveness studies Illustrate basic types of analyses that contribute to product value evidence Examine requirements for value evidence by payers across major global markets Understand the role of cost-effectiveness analyses throughout the drug development and marketing process
DDPM-210R - Biologics and Biosimilars Drug Development (Ma. J., Chen, H., Vande- Casteele, N.) This course explains how biologics are developed and commercialized as therapeutics, explores how the process differs from the traditional pharmaceutical approach for small molecules, and outlines the challenges and opportunities for producing more affordable generic equivalents, also known as biosimilars. The Biologics and Biosimilars course has three key objectives: (1) explain how biologics are developed and commercialized as therapeutics, (2) explore how the process differs from the traditional pharmaceutical approach for small molecules, and (3) outline the challenges and opportunities for producing more affordable generic equivalents, also known as biosimilars.
Course Objectives:
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Define basic concepts of recombinant DNA technology and terminology. Describe key phases of biologics research and development, from target identification through the end of clinical testing and regulatory approval. Compare and contrast the biologics process with that for small molecule pharmaceuticals. Explain the scientific and regulatory challenges that have limited the development and approval of follow-on equivalents of biologics, or biosimilars. Review recent advances in analytical and regulatory sciences that facilitate the development of biosimilars. Highlight regulatory pathways available for biosimilars approval in the US, Europe, and other key geographic regions. Outline opportunities and areas of uncertainty for the development and commercialization of biosimilars. Explore how biosimilars development and approval will influence pharmaceutical patent life cycle and portfolio strategies.
DDPM-211R - Managed Markets - Post Marketing Drug Utilization Management (Forrester, C. and Wong, F.) This course provides an overview of U.S. Managed care system and will teach how to navigate the system to successfully launch new drugs in a managed care environment. This course provides an overview of U.S. FDA regulations governing drug and biologic development and post-approval marketing. Practices in information access, submissions, FDA inspections, and quality guidelines (GLP, GCP, GMP) will be covered.
Course Description: This 4-unit course will provide insights to the various types of managed markets, how they are structured and the tools used in each to provide high quality, effective and affordable prescription drug benefits. The course will also use case studies to evaluate methods of positioning products in various managed markets to achieve market access, capture market share and improve product profitability
Course Objectives: Have an awareness of managed markets and their function in the United States health care system. Have a basic knowledge of the various parties who determine prescription drug benefit design along with their goals and motivations. Demonstrate a basic understanding of the prescription drug formulary development process and its regulation along with its impact on drug product management. Understand the basic tenets of contracting for drug product placement in managed markets.
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Proposal for a Master of Science Degree in Drug Development and Product Management
Recognize common and emerging managed care drug product utilization controls and tools. Understand current drug pricing methods, the parties each benchmark impacts, their strengths, weaknesses and their applications to various managed market components.
DDPM-213R - Health Outcomes Evidence (Cuomo, R.) This course examines the breadth of data and study types that build evidence of a product’s value from potential estimates during the early development stages through to post marketing actual value realized over time in various populations. This course examines the breadth of data and study types that build evidence of a product’s value from potential estimates during the early development stages through to post marketing actual value realized over time in various populations.
Course Objectives: Review common sources of health outcomes evidence including clinical, economic and humanistic outcomes Examine the application, strengths and weaknesses of value evidence data from Phase 2, 3 and 4 clinical trials Describe common analysis techniques and strategies for assessing product value using pharmacy and medical claims utilization data Describe modeling methodologies, including regression, decision analytic, and Markov techniques, commonly used to examine product value post marketing Discuss appropriateness, limitations and strategic utilization of different types of data and analyses across the drug development and management continuum
DDPM-214R - Business Development & Entrepreneurship, Corporate & Intellectual Property Strategy (Ettouati, W., Nguyen, C., Evans, W.)
This course will be split into three parts:
First: Building a Biotech Company This course will provide students with a clearer understanding of the opportunities and challenges on how to build a biotech company. The most successful biotech entrepreneurs all possess these two components, a clear vision and passion. Entrepreneurial passion is not an emotional characteristic, but a driving desire to accomplish something they firmly believe in, and will do, no matter how difficult the challenge. Being a visionary involves identifying something others cannot see and communicating what they perceive in a way that inspires other people to follow, especially investors.
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Proposal for a Master of Science Degree in Drug Development and Product Management
Second: Business Development (BD) This course will deliver a clear understanding of pharmaceutical, and biotech business development. Case studies will be used to understand the complexity and diversity of deals. Business development professionals rely upon scientific experts within the research, development, and marketing departments of their company to assess potential incoming technologies. BD also works closely with finance, legal, and other corporate functional groups to ensure that the structure of a proposed deal is appropriate for their firm.
Third: Corporate & Intellectual Property This course will allow students to grasp key concepts regarding corporate law and intellectual property as it pertains to the biotechnology and pharmaceutical industries.
Course Objectives: Understand what it takes to create a new biotech company Provide an in-depth understanding of the role of business development in Pharma, Biotech, and Academia Understand the importance of open innovation and the impact on R&D Discuss the multi-facets of business deals, from initiation to close, and learn to evaluate and negotiate Learn how to conduct patent searches 6 Resource Requirements and Impact on the Academic Unit Using the approved SAPD template for graduate program financial reporting and fee requests, Appendix E of this document outlines financial projections for this self- funded program.
This program is entirely self-funded and does not receive any state or federal subsidies. The program leaders are responsible for ensuring expenses do not exceed revenues, and the program is self-sustaining. Program surpluses or very small deficits will be deferred to the following fiscal year. After annual budget reconciliation, any surpluses will be reinvested for the benefit of the MS in DDPM program and students, or to offset any outstanding deficit.
The budget for this degree program meets all direct and indirect financial commitments, including assigned assessments for the division (SSPPS), the relevant vice chancellor (VCHS), and the office of the chancellor. Current UC San Diego policy for assessments on new master’s programs states that Graduate Division and ASSA assessments will be covered as part of the assessments to the vice chancellor and chancellor. The UCOP assessment for this program will be covered as part of the overall UC San Diego Extension assessment addressed by the EVCAA.
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Proposal for a Master of Science Degree in Drug Development and Product Management
No library acquisitions are required for this program, nor any special computing costs or special equipment. Standard campus support of an online learning platform is included in program assessments. Test proctoring services (for online students) will be funded by the program.
No special space or capital facilities are required as the program will be online.
Administrative support for the program will be provided by UC San Diego Extension. Under the direction of SSPPS, UC San Diego Extension will manage student services support admissions counseling and assisting faculty with recruitment development and execution of program administrative policies program finances instructor and student servicing coordination of online course development
UC San Diego Extension has extensive experience in administering self-supporting professionally oriented degree programs at UC San Diego. This arrangement will ensure no adverse administrative impact on SSPPS.
Under the direction of the SSPPS MS in DDPM faculty, UC San Diego Extension established accounts for this program in a managed fund, including a program reserve account for any program surplus or deficit accumulated over time, and maintains complete separation of those funds from any other UC San Diego Extension activities. All fee income program expenses will be managed and processed on these funds, including any compensation to faculty who teach on overload, recharges to departments who assign faculty as part of their regular load, or “buy-outs” of faculty time. Campus assessments are recharged to the program. The program is subject to annual review and approval by UCOP for program fees and overall financial viability.
6.1 Development Costs Associated with Movement to Online Delivery Through the UC San Diego campus initiative, the Strategic Academic Program Development (SAPD) is collaborating with the Digital Learning Hub, Teaching & Learning Commons, Information Technology Services (ITS), and UC San Diego Extension. Through the initiative, SAPD is shouldering the up-front costs of the development of online courses, with the expectation that self-funded courses and programs that are developed will be fully self-funded within 3 years. As a result, development costs outlined in Appendix E are separate from projected 3-year operating costs. Costs associated with developing and offering the program online are reflected in the Appendix E Cost Analysis as one-time expenses.
The EVC has provided substantial funding to both the Teaching + Learning Commons
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Proposal for a Master of Science Degree in Drug Development and Product Management
and ITS for FTEs and resources to support online degree programs. (Please see EVC presentation to Senate Administration Council, November 18, 2019 for documentation).
The initial cost of the program is not considered a subsidy. The EVC is providing in kind support for instructional design consultation, video recording, and other services provided by the Teaching and Learning Commons and Educational Technology Services prior to program inception. Any services needed from the Commons or ETS after program inception will be provided by the program and no subsidies will be provided by the EVC. See Feb 6 proposal Section 6.1 Development Costs Associated with Movement to Online Delivery.
Costs associated with the development of online courses consist of two elements: The Commons will support program development by offering support for Program Design, Course Design, Instructional Design, Program Assessment, Student Support, Program and Course Approvals. ITS will offer support for Media Services, educational technology support, Campus LMS support (Canvas and Open edX), and Learning Analytics from Canvas and Open edX.
Second, the MS in DDPM program will cover the costs of compensating lead faculty a one-time stipend of $5,000 per 1-unit, assuming 4-unit courses to work with The Common’s and ITS to create online learning instructional design and technology support personnel to capture lectures and create suitable online learning activities, supplemental learning material, and self-assessment quizzes. This stipend may be allocated among a number of faculty associated with a course if that is deemed appropriate. Ten courses will be developed for fully-online delivery, totaling $234,000 (includes benefits) in faculty compensation stipends. Compensation of $5,000 per unit is based on this additional time.
Education researchers and those knowledgeable about high-quality online education have termed the hurried move away from face-to-face instruction due to COVID-19 as emergency remote instruction (ERT).
A face-to-face course does not directly translate into a pedagogically designed student-centered online course. Conceiving, planning, designing, and developing a genuine online course takes months of faculty time in collaboration with instructional designers and media technologists. The need to “just get it remote” (ERT) is in direct contradiction to the time and effort normally dedicated to a quality online course.
Based on data from previously developed online courses, the Commons’ Digital Learning team estimates that faculty need to dedicate approximately 150 hours to the creation of a 4-unit course while working with the instructional designers and media technologists. The DDPM courses will need to be completely redesigned for
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Proposal for a Master of Science Degree in Drug Development and Product Management
effective online delivery according to the following process.
Scoping: Faculty develop a “course map” organizing course structure around learning units. Each learning unit is broken down into components (learning activities, instruction, assessments) mapped to learning outcomes.
Design: Faculty work with a Commons’ instructional designer (ID) to match the course map to instructional methodologies and tools that achieve the stated learning outcomes: video lectures, assignments, projects, assessments, and rubrics.
Development: Faculty work with media specialists and IDs to create the course content: asynchronous, sequenced video lectures (5-10 minutes in length followed by polling questions), power points, formative and summative assessments, group projects, discussion forum prompts, course communications and engagement opportunities.
Delivery: The DDPM curriculum is highly interactive and our Faculty utilize many case studies for students to work in teams and apply knowledge gained in class. Once all of the content has been developed, Faculty will interact with students regularly throughout each week through live Zoom and Virbela sessions to discuss case studies and have Q&A sessions.
In conclusion, faculty will be required to scope, design, develop and deliver a quality online course. The estimated time commitment for a 4-unit course online course is approximately 150 hours. Since this is above and beyond their current teaching load, faculty need to be compensated for their work fairly and appropriately.
In subsequent years 2-5 and thereafter, the MS in DDPM program budget will cover additional faculty compensation to refresh courses, and to work with The Common’s and ITS to keep content current in the online format.
The Campus (Office of Executive Vice Chancellor) has invested 9 FTEs and ~$1.3M of the overall budget of the Teaching + Learning Commons in dedicated support for digital course and program design, development and assessment via The Digital Learning Hub (7 FTE) and the Assessment Hub (2 FTE). Likewise, the EVC has invested seven FTEs to Information Technology Services (ITS) for dedicated Ed Tech Staffing to provide technology and media support for digital course production and technical support to learners. The services provided by the Teaching + Learning Commons and ITS for digital learning are available to faculty campus-wide who are resourced by Strategic Academic Program Development Initiative (Educational Innovation) and thus do not need to be accounted for in the program budget.
Appendix E additionally outlines how the program will fund Instruction, Course
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Proposal for a Master of Science Degree in Drug Development and Product Management
Assistance, Program Leadership, Student Advising, Career Services, Marketing and Recruitment, as well as Operating Costs and licensing expenses. In addition, the Revenue Share Model outlines program contributions to student financial aid, Campus, the SSPPS Dean and to the Academic Units.
Per the stated goals and procedures of the campus Master’s Growth Initiative, the funds provided by the assigned assessments will be used as follows: The annual Chancellor’s share is to support campus-wide overhead costs associated with the MS programs, including share of campus ASSA assessment, OP assessment and other infrastructure needs begins at 11%, and caps at 33% by year 3.
The 7% annual SSPPS Dean’s share is to support the indirect costs at the Division/School level as well as general academic programs of the School/Division. The Dean has the discretion to return this to the unit.
The MS in DDPM program will contribute 10% of total annual revenues to the student financial aid fund.
The remaining percentage of funds will remain with the Academic Unit. During the first year of the fully online program, 72% of the revenue will be invested in developing program content and marketing the program globally. In its third year, the program will retain 50% of total revenues to reinvest in the program, and to develop program-based scholarships to attract a diverse group of students.
Voluntary faculty who chair a course will be compensated to develop and teach their course. Other resources devoted to this MS program will be separate from the PharmD and PhD programs and have been considered as such in the faculty’s assessment of their time needed. Faculty who will be chairing courses are fully committed to teaching in this program as an overload and will be compensated accordingly through program revenues. Much of the time consuming work of producing the lecture videos can be done at times, summer for example, when faculty are not engaged in other courses.
Volunteer faculty who give individual lectures as part of the online format will not be compensated. In the past we have found that volunteer faculty from industry are eager to be involved even without compensation. We have extensive experience with multiple courses that successfully utilize volunteer faculty to provide lectures from the pharmaceutical and managed care industries without compensation. In particular, our experience with the Drug Discovery Development and Commercialization course, which has been taught at UC San Diego for the past eight years, has had many guest speakers volunteer from industry who were willing to teach, annually, without any compensation. The Digital Learning Hub at The
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Proposal for a Master of Science Degree in Drug Development and Product Management
Common’s will provide training and support for the volunteer faculty that may be featured as guest lecturers for online content.
The cost analysis also includes compensation for a course assistant for each course offered online as well as a 25% increase in faculty compensation to handle increased student interaction. The program is budgeting for the contingency of needing additional funds for course updates and improvements (e.g. software licensing, unique equipment, or capture of on-site footage at appropriate pharmaceutical facilities), and/or increased technical assistance to students and instructors during the launch of each course.
Initial Marketing efforts to target an international audience will require dedicated attention once the program is approved. The development budget includes a half- time contract position for nine-months prior to year four, to supplement UC San Diego Extension marketing resources and to purchase promotional attention (primarily digital ads and sponsored social media). The total cost of initial marketing of the fully online delivery option is estimated to be $100,000. Ongoing annual international promotional costs are incorporated into the Appendix E Cost Analysis.
7 Graduate Student Support Because the MS in DDPM program receives no state or federal funding, students enrolled in the MS in DDPM program do not qualify for teaching assistantships nor research assistantships.
7.1 Financial Assistance As part of the SAPD initiative, the MS in DDPM program will contribute 10% of total revenue annually towards the student financial aid fund. US students pursuing self- funded graduate programs are eligible for federal student financial loans, although they are not eligible for state (i.e., taxpayer-funded) financial assistance (subsidized loans). International students would need to apply for loans in their home country.
For a new, entirely self-funded program, we believe that offering one in every five students up to a 50% fee discount is admirable and generous. That amount is also consistent with the standard established by the campus Master’s Growth Initiative. As enrollment reaches full expectations, and student demographics and financial needs are better understood, the program will consider increasing the percentage returned to financial assistance.
As previously noted, the self-funded program will not provide employment, research, teaching, nor training grants to students. Students most likely will be based in regions where there are pharmaceutical companies, and thus will be residing across the United States and overseas locations as they pursue the program. Many will be working professionals, so grants of this nature would not be practical for students
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Proposal for a Master of Science Degree in Drug Development and Product Management
pursuing the degree online. UC San Diego will not be involved in the employment matters or compensation process for students enrolled in the online program.
8 Governance This program will be managed by the SSPPS which will advise the program leaders on the curriculum, faculty selection and review, admissions, and student evaluation. Key industry partners will be consulted periodically in the selection of learning objectives, curriculum topics, and relations with industry and employers in order to ensure the effort is well coordinated and supportive of overall Health Sciences strategy.
Dr. Joseph Ma, Professor of Clinical Pharmacy will be the Faculty Director of the program, providing oversight of faculty selection and performance, as well as academic policy and decisions, including student evaluations. Dr. Williams Ettouati, Health Sciences Associate Clinical Professor and Director of Industry Relations and Development, will be Managing Director of the program, supervising day-to-day operations (including course related student interactions), recruiting student mentors, and overseeing student internships. Dr. Jeremiah Momper, Associate Professor of Clinical Pharmacy and Dr. Felix Yam, Health Science Associate Professor will also be part of the program steering committee, participating in academic policy decisions and matters of program marketing and design strategy.
The program also will receive oversight from the SSPPS Committee on Educational Policy (CEP) and the UC San Diego Graduate Council regularly.
9 Changes in Senate Regulations Required No changes in Senate regulations are required at the system wide level.
This proposal seeks approval to be offered in an online format and will be reviewed by the UC San Diego Academic Senate Graduate Council.
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Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix A: Program & Pace of Study Appendix A: Program and Pace of Study for a Master of Science Degree in Drug Cohort 1 Development & Product Management FA20-SP21 Online Q1 Q2 Q3 Course Title Units Faculty Course # FA18 WI19 SP19 Opportunities in Pharma, Biotech and Managed Care DDPM-200R 1 W. Ettouati, PharmD X
Pharmacotherapy and Diseases DDPM-201R 3 Felix K Yam, PharmD, MAS, BCPS, BCCP X B. Best, PharmD Pharmaceutics for Small Molecules and Macromolecules DDPM-202R 4 C. Reed, PhD X Pre-Clinical & Clinical Regulatory Submissions and Strategy DDPM-203R 4 J. Momper, PharmD, PhD X
Clinical Trial Development from Phase 0 to Phase 3 Studies DDPM-204R 4 J.Ma, PharmD X
W. Ettouati, PharmD Principles of Marketing Strategy, Product Value, and Life Cycle DDPM-208R 4 K.Lyons, PharmD X Management D. Doshi J.Ma, PharmD Biologics and Biosimilars Drug Development DDPM-210R 4 H. Chen, MD X N. Vande Casteele, PharmD, PhD
Managed Markets - Post Marketing Drug Utilization F.Wong, PharmD DDPM-211R 4 X Management C.Forrester, PharmD
Health Outcomes Evidence DDPM-213R 4 R. Cuomo, PhD X
W. Ettouati, PharmD Business Development, Entrepreneurship, Corporate, and DDPM-214R 4 C. Nguyen, JD X Intellectual Property Strategy W. Evans, JD Comprehensive Exam n.a. n.a. n.a. X
Total Units for MS Degree: 36 12 12 12 Total # Courses Offered: 10 NOTE: Refer to Quarterly Course Schedule for specific course dates and times. Schedule Subject to Change. As of 3/21/19 Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix B: Market Assessment
MS in Drug Development and Product Management Market Analysis Report December 2018
1
CONTENTS Key Findings ...... 4 Competitive Landscape Analysis ...... 5 Figure 1: Drug Development and Product Management Themes ...... 5 Figure 2: List of Drug Development Competitive Landscape Programs ...... 6 Program Length ...... 6 Figure 3: Time Required for Completion of Master’s Programs ...... 7 Internships and Thesis Requirements ...... 7 Figure 4: Internship and Thesis Requirements ...... 7 Program Format ...... 8 Figure 5: Program Format ...... 8 Tuition ...... 9 Figure 6: Comparative Program Fees ...... 9 Prerequisites ...... 10 Figure 7: Prerequisites for Master’s Programs ...... 10 Curriculum Comparison ...... 10 Figure 8: Competitors Required Coursework ...... 11 Figure 9: Curriculum Analysis ...... 13 Figure 10: Frequency of Comparative Courses at Other Programs ...... 14 Occupational Outlook ...... 15 Figure 11: Projected Occupations ...... 15 Figure 12: Required Skills for Identified Future Occupations ...... 15 Survey Findings ...... 16 Figure 13: Appeal of the Degree ...... 16 Figure 14: Degree Appeals to Colleague ...... 16 Figure 15: Gender by Degree Appeal ...... 17 Figure 16: Age Brackets ...... 17 Figure 17: Age Bracket by Degree Appeal ...... 18 Figure 18: Degrees of Respondents (n=104) ...... 18 Figure 19: Educational Attainment by Personal Degree Appeal ...... 19 Figure 20: Majors of Respondents ...... 19 Figure 21: Industries of Respondents ...... 20
2
Figure 22: Years of Work Experience in Field ...... 20 Figure 23: Reasons DDPM Degree is Appealing ...... 21 Figure 24: Reasons DDPM Degree is Not Appealing ...... 22 Figure 26: Perceived Value of DDPM Skills (Skills rated Valuable or Extremely Valuable; n=104) .... 24 Figure 27: Format of Program ...... 25 Figure 28: Preferred Type of Hybrid Format ...... 25 Return on Investment (ROI) Framework...... 26 Career Advancer: Medical Scientist ...... 27 Figure 29: Customer Service Representative to Computer Systems Analyst Career Starter ROI Calculation ...... 27 Career Advancer ...... 28 Figure 30: Market Research Analysts and Marketing Specialists to Operations Research Analyst Career Advancer ROI Calculation ...... 28 Appendix A ...... 29 Competitor Programs...... 29 Appendix B ...... 32 Graduate ROI Framework – Medical Scientist (Figure 29 Calculations) ...... 32 Graduate ROI Framework – Medical and Health Services Manager (Figure 30 Calculations) ...... 33
3 Key Findings • The typical Master’s degree in Drug Development and Product Management (DDPM) lasts 18-24 months, has 53 quarter units, is offered both (67%) on-site (22%) and online (11%), can be attended both full-time and part-time, and costs about $50,134 (in-state tuition) and $52,843 (out-of-state tuition). • Competitor programs share at least 50% of comparative courses with UCSD. • UCSD is competitive in offering lower tuition ($42,000), a faster program (one year), and a unique course in Entrepreneurship and Intellectual Property Strategy. • The top three most valuable skills for in jobs for graduates were budgeting, project management, and product management. • Nearly eighty percent of survey respondents felt that the DDPM degree was at least "maybe" appealing, regardless of gender, age, or education. • Respondents were most interested in the DDPM degree because of industry recognition of the degree, career advancement potential, and building industry connections. • By contrast, lack of interest came from lack of time, lack of potential career advancement, and cost. • Skill attainment and post-graduate occupational outlook were the most important factors influencing enrollment decisions. • Eighty percent of respondents valued 11 out of 12 of the program's skills. • Most respondents preferred a hybrid option (62%) over on-site only (20%) or online only-enrollment (32%). Furthermore, when evaluating the hybrid format, most preferred attending both of in-person and online courses (79%) over the on-site two-week options for networking (45%) or orientation (41%). • Respondents reported no preference for part-time or full-time enrollment (50% each).
4 Competitive Landscape Analysis Because of the interdisciplinary nature of the Drug Development and Product Management (DDPM) program, it was challenging to find programs that were directly comparable. As a result, the research team created a framework for program selection. To be included, comparable programs must offer courses in natural science (e.g., chemistry, biology, pharmaceuticals, etc.), business, and regulation because DDPM is situated at the intersection of all three topics (see Figure 1). Consequently, related programs, such as Regulatory Affairs or Pharmaceutical Sciences and Drug Development were excluded for lacking a single component. Appendix A displays the full list of programs that were considered.
Figure 1: Drug Development and Product Management Themes
Regulation Natural Science
Business
The research team identified ten domestic and international master’s programs related to DDPM (see Figure 2). These programs ranged from top-ranking institutions to public institutions. Most programs target recent undergraduates, though some prefer work experience before enrollment.
5 Figure 2: List of Drug Development Competitive Landscape Programs1
Institution Name of Program Location Program Quarter Out-of- Length Units State (months) Tuition CUNY York College Master of Science in Pharmaceutical New York, 24 54 $29,880 Science and Business USA Drexel University Master of Science in Drug Discovery and Pennsylvania, 24 57 $42,978 Development USA Keck Graduate Master of Business and Science in California, 24 65 $79,800 Institute Bioscience; Emphasis in Clinical USA Regulatory Affairs Northeastern Master of Science in Biotechnology Boston, USA 24 34 $79,800 University School of Professional and Continuing Studies Rutgers University Master of Business and Science in New Jersey, 18 65 $52,503 Business Science; Drug Development USA Concentration Rutgers University Master of Science in Clinical Trial Science New Jersey, 18 54 $36,324 USA University of Master of Science in Pharmaceutical England, UK 60 N/A N/A Manchester Industrial Advanced Training University of Master of Science in Management of Drug California, 18 48 $58,560 Southern California Development USA University of Master of Science in Medical Product California, 18 48 $58,560 Southern California Quality USA University of Master of Science in Regulatory Science California, 18 54 $65,880 Southern California USA
Program Length
Average completion time ranged from 18-24 months (see Figure 3). Note that the University of Manchester program was excluded from analyses because it only had a part-time program, and the remaining nine programs were calculated on full-time enrollment. The average completion time for a Master’s in Drug Development or a comparable field is 20.7 months with an average of 53.2-quarter units of work. Because eight of the nine programs offer both part-time and full-time options, students can take more than two years to complete their degrees. Only Keck Graduate Institute requires full-time completion.
1 Semester units were converted to quarter unit credits.
6 Figure 3: Time Required for Completion of Master’s Programs
56%
44%
18 months 24 months
Internships and Thesis Requirements
Keck Graduate Institute and Northeastern University required internships, and five programs offered optional internships. Additionally, Keck Graduate Institute required a thesis, and Drexel University offered an optional thesis (see Figure 4).
Figure 4: Internship and Thesis Requirements
78%
56%
22% 22%
11% 11%
Internship Thesis
Required Optional None
7 Program Format
Out of the nine programs evaluated, six programs can be taken both on-site and online. By contrast, both Keck Graduate Institute and CUNY York College require on-site instruction. Lastly, Rutgers University’s Clinical Trial Science program is the only online-focused program (see Figure 5).
Figure 5: Program Format
67%
22%
11%
On-site Both Online
8 Tuition
The average cost of the domestic Master’s programs evaluated is $50,134 for in-state student tuition and $52,843 for out-of-state non-resident tuition (see Figure 6).
Figure 6: Comparative Program Fees
$79,800 Keck Graduate Institute $79,800
$65,880 University of Southern California (Regulatory Sc.) $65,880
$58,560 University of Southern California (Medical Product […]) $58,560
$58,560 University of southern California (Management […]) $58,560
$51,102 Northeastern University $51,102
$42,978 Drexel University $42,978
$52,503 Rutgers University (Business Science) $41,624
$36,324 Rutgers University (Clinical Trial Science) $36,324
$29,880 CUNY York College $16,380
Non-Resident Resident
9 Prerequisites
Of the nine Master’s programs analyzed, all had prerequisites for their programs. Figure 7 shows a snapshot of the prerequisites for the master’s program.
Figure 7: Prerequisites for Master’s Programs2
Undergrad in Natural Science 44%
Organic Chemistry 22%
Molecular Biology 22%
Biochemistry 22%
Biology 22%
Chemistry 22%
Other courses 11%
Nearly half of the programs required a bachelor’s degree in the natural sciences. Only three programs (CUNY York College, Northeastern University, and Rutgers Business and Science degree) required specific science classes. Lastly, CUNY York College required other specific courses, such as Genetics, Physiology, Physics, and Calculus.
Curriculum Comparison Domestic master’s programs averaged 53.2 quarter units for a degree. UCSD’s program is comparable with 48 quarter hours.
The proposed curriculum for UC San Diego’s DDPM degree consists of the following:
• Opportunities in Pharma, Biotech, and Managed Care • Pharmacotherapy and Diseases • Pharmaceutics for Small Molecules and Macromolecules • Pre-Clinical and Clinical Regulatory Submissions and Strategy • Clinical Trial Development from Phase 0 to Phase 3 Studies • Foundations of Project Management • Principles of Marketing Strategy, Product Value & Life Cycle Management • Biologics and Biosimilars Drug Development • Managed Markets: Post-Marketing Drug Utilization Management • Health Outcomes Evidence • Business Development, Entrepreneurship, Corporate, and Intellectual Property Strategy
2 May total more than 100 percent as some programs had multiple prerequisites.
10 The required courses for competitor programs are provided in Figure 8, and concentrations are bolded. Figure 9 provides a visualization of the DDPM curriculum as it compares with competitive programs. Given the amount of freedom for course selection Figure 8 exhibits, Figure 9 may overestimate how many courses of other programs mirror UCSD’s DDPM program. Although competitors programs’ course titles vary, many teach similar concepts. Figure 10 reinterprets Figure 9 as course frequencies, offering a summary of courses.
Figure 8: Competitors Required Coursework
Pharmaceutical Discovery and Development; Pharmaceutical Discovery and Development Techniques; Advanced Pharmacology; Advanced Biostatistics; Foundations of Regulatory Affairs; Pharmaceutical Ethics and Intellectual Property Management; Pharmaceutical Industry and Business; Pharmaceutical Science and Business Capstone Project; Pick four courses: PHS CUNY York or Biotherapeutics or Advanced Pharmaceutics or Special Topics in Pharmaceutical Discovery College and Development or Pharmaceutical Quality Assurance, Process Validation and Controls or Design of Clinical Trials or Advanced Toxicology or International Regulatory Affairs or Pharmaceutical Product Labeling or Writing and Submission of Regulatory Applications or Pharmaceutical Supply Chain Management or Pharmaceutical Marketing or Pharmaceutical Product Management or Pharmaceutical Project Management
Responsible Conduct of Research I; Statistics for Neuro/Pharm Research II; Graduate Pharmacology; Drug Discovery & Development I and II; Research in Drug Discovery & Drexel Development; Current Topics in Pharmacology & Physiology; Advanced Topics in University Pharmacology; Biostatistics I Project Management; International Project Management
Molecular Biotechnology; Introduction to Bioprocessing; Medical Diagnostics; Medical Devices; Pharmaceutical Discovery; Pharmaceutical Development; Healthcare and Life Science Industry Keck Ethics; Applications of Statistics; Finance and Accounting Principles; Corporate Finance; Graduate Bioscience Strategy; Introduction to Bioscience Industries; Business/Science Communications; Institute Introduction to US Food and Drug Law; Professional Development; Business courses (6 units); Technical courses (6 units); Data analytics course (3 units) Introduction to Biotechnology; The Biotechnology Enterprise; Cell Culture Processes for Biopharmaceutical Production; Experimental Design and Biostatistics; Molecular Cell Biology for Biotechnology; Protein Chemistry; Analytical Biotechnology; Professional Development for Co- op; Co-op Work Experience Molecular Biotechnology: Basic Biotechnology Lab Skills; Cutting-Edge Applications in Molecular Biotechnology; Higher-Order Structure Analytics; Biotechnology Applications Laboratory Process Sciences: Basic Biotechnology Lab Skills; Bioprocess Fundamentals; Downstream Processes for Biopharmaceutical Production; Biotechnology Applications Laboratory Biopharmaceutical Analytical Sciences: Basic Biotechnology Lab Skills; Biotechnology Applications Laboratory; Introduction to Glycobiology and Glycoprotein Analysis; Protein Mass Northeastern Spectrometry University Pharmaceutical Technologies: Basic Biotechnology Lab Skills; Drug Product Processes for Biopharmaceuticals; Molecular Interactions of Proteins in Biopharmaceutical Formulations; Biotechnology Applications Laboratory Scientific Information Management: Basic Biotechnology Lab Skills; Scientific Information Management for Biotechnology Managers; Biotechnology Applications Laboratory; Either Collecting, Storing, and Retrieving Data or Introduction to Data Mining/Machine Learning; Introduction to Computational Statistics Regulatory Science Concentration: BIOT 5330 Unnamed course; Introduction to Biotherapeutic Approvals; Introduction to Regulatory Science; Biotechnology Applications Laboratory Biotechnology Enterprise Concentration: Managing and Leading a Biotechnology Company; Biotechnology Entrepreneurship; Economics and Marketing for Biotechnology Managers
11 Principles of Communication and Professional Development; Principles of Accounting and Finance for Science and Technology; Market Assessment and Analysis for Business and Rutgers Science; Ethics in Science and Technology Management; Science and Technology University Management Capstone; Fundamentals of Intellectual Property; Drug Development from (Business and Concept to Market; Drug Discovery through Preclinical Development; Fundamentals of Science) Biological Chemistry in the Biotech Industry; Pick two courses: Practical Aspects of Clinical Trial Design/Conduct or Fundamentals of Regulatory Affairs or Statistics in Clinical and Translational Research Clinical Trials Overview: Methods and Practice; Regulatory and Ethical Requirements in Clinical Investigations; Scientific Writing for the Translation of Medicine; Either Capstone Course or Evidence Based Literature Review Informatics: Health Care Information Systems; Clinical Trial Data Management; Health Data Analytics using SAS; Electronic Health Records; Healthcare Information Processing Using XML; Using Computerized Systems in Clin Res/Risk Mgt; Clinical Operations Management & Recruitment: Clinical Trial Data Management; Overview of Disease Processes and Treatment; Applied Clinical Trials & GCP; Clinical Operations; Principles of Subject Recruitment and Retention; Either Multiple Analyses in Clinical Trials or Data Analysis & Interpretation I Rutgers Regulatory Affairs: Adverse Event Reporting & Postmarketing Activities; Concepts of GxPs University and Quality Assurance; Regulatory Requirements for Medical Devices and Diagnostics; (Clinical Trial International Regulatory Affairs; Reg Writing for Submissions and Publications; Either Multiple Science) Analyses in Clinical Trials or Data Analysis & Interpretation I Drug Safety & Pharmacovigilance: Overview of Disease Processes and Treatment; *BPHE 5725: Adverse Event Reporting & Postmarketing Activities; *BPHE 5780: Principles of Pharmacovigilance: Regulations & Drug Safety Reporting; Signal Management & Quantifying Risk; Risk Management Tools; Clinical Pharmacology; Either Multiple Analyses in Clinical Trials or Data Analysis & Interpretation I; Either Pharmacoepidemiology or Pharmacoepidemiology & Therapeutic Risk Management Medical Affairs: Overview of Disease Processes and Treatment; Applied Clinical Trials & GCP; International Regulatory Affairs; Special Topics in Clinical Trial Sciences; Scientific Writing for the Translation of Medicine; Advertising & Labeling / Pharmaceutical Medicine; Strategy, Insight Generation and Patient Journey; The Practice of Medical Affairs University of Biomedical Commerce; Structure & Management of Clinical Trials; Industrial Approaches to Drug Discovery; Either Introduction to Medical Product Regulation or Regulation of Drugs and Southern Biological Products; Either Early Stage Drug Development or Safety Evaluation During Drug California Development; Either Quality Assurance for Drugs and Biologics or Quality Systems & (Management Standards or Introduction to Drug & Food Toxicology or Chemistry Manufacturing and Control; of Drug Either Quality Systems & Statistical Process Control or Introduction to Clinical Trial Design & Development) Statistics University of Quality Systems & Statistical Process Control; Managing Complex Projects; Introduction to Southern Medical Product Regulation; Pick four courses: Auditing Principles or Quality Assurance for California Drugs and Biologics or Quality Assurance for Medical Devices & Combination Products or (Medical Quality Systems & Standards or Structure & Management of Clinical Trials or Chemistry Product Manufacturing and Control; Either Introduction to Risk Management for Health Care Products or Quality) Medical Product Safety Introduction to Medical Product Regulation; Structure & Management of Clinical Trials;; Medical University of Products & the Law; Biomedical Commerce; Either Quality Systems & Statistical Process Southern Control or Introduction to Clinical Trial Design & Statistics; Either Quality Assurance for Drugs California and Biologics or Quality Assurance for Medical Devices & Combination Products or Quality (Regulatory Systems & Standards; Pick two courses: Regulation of Pharmaceutical & Biologic Products or Science) Regulation of Medical Devices & Diagnostics; or Regulation of Food & Dietary Supplements or Introduction to Food Science & Toxicology
12 Figure 9: Curriculum Analysis
13 Figure 10: Frequency of Comparative Courses at Other Programs
Principles of Marketing Strategy, Product Value & Life Cycle 100% Management
Biologics and Biosimilars Drug Development 89%
Foundations of Project Management 89%
Clinical Trial Development from Phase 0 to Phase 3 Studies 89%
Pre-Clinical and Clinical Regulatory Submissions and Strategy 89%
Managed Markets: Post-Marketing Drug Utilization 78% Management
Pharmaceutics for Small Molecules and Macromolecules 67%
Pharmacotherapy and Diseases 67%
Health Outcomes Evidence 56%
Opportunities in Pharma, Biotech, and Managed Care 56%
Business Development, Entrepreneurship, Corporate, and 33% Intellectual Property Strategy
Overall, UCSD’s DDPM program is particularly competitive on its Entrepreneurship and Intellectual Property course because only 33% of programs offer a similar course. Two programs (CUNY York College and Rutgers University Business and Science) share 100% of comparative courses with UCSD, and all competitor programs share at least 50% of comparative courses with UCSD.
However, other programs offer students a greater degree of course selection than UCSD. For instance, only one program requires students to attend specific courses. Six programs permit choices on a list of courses, one offers electives, and two offer concentrations once core coursework is completed. Keck Graduate Institute and Rutgers University (Business and Science) are unique in offering a course in Accounting and Finance Principles.
14 Occupational Outlook Figure 11 displays both future occupations for the skillsets acquired from the DDPM program and the projected change in employment from 2016-2026 nationwide. While some occupations have high change rates, there may be a small number of available jobs. Figure 12 displays the top 10 required skills desired by employers for these positions nation-wide (Master’s degree level). The top three most desirable skills are budgeting, project management, and product management.
Figure 11: Projected Occupations
Occupation SOC 2016 Jobs 2026 Jobs % Change Marketing Managers 11-2021 218,300 240,400 10.1% Training and Development Managers 11-3131 34,500 38,100 10.3% Medical and Health Services Managers 11-9111 352,200 424,300 20.5% Natural Sciences Managers 11-9121 56,700 62,300 9.9% Market Research Analysts and Marketing Specialists 13-1161 595,400 733,700 23.2% Operations Research Analysts 15-2031 11,400 145,300 27.4% Statisticians 15-2041 37,200 49,800 33.8% Biological Scientists, All Other 19-1029 38,700 41,800 8.0% Medical Scientists, Except Epidemiologists 19-1042 120,000 136,100 13.4% Media and Communication Workers, All Other 27-3099 32,900 36,200 9.9% Clinical Laboratory Technologists and Technicians 29-2010 335600 378400 12.8% Medical and Clinical Laboratory Technologists 29-2011 171,400 191,200 11.5% Medical Records and Health Information Technicians 29-2071 206,300 234,100 13.5% Medical Transcriptionists 31-9094 57,400 55,500 -3.4%
Figure 12: Required Skills for Identified Future Occupations
Skills Job Postings Budgeting 26.6% Project Management 20.5% Product Management 17.5% Marketing 12.6% Product Development 12.1% Staff Management 11.9% Patient Care 11.0% Business Development 10.5% Quality Assurance and Control 10.2% Scheduling 9.2%
15 Survey Findings
Forty percent of respondents surveyed were interested in the Master’s degree in DDPM at UCSD (see Figure 13). Thirty-eight percent of respondents expressed that they would “maybe” consider the degree.
Figure 13: Appeal of the Degree (n=104)
40% 38%
21%
No Maybe Yes
When asked whether a colleague would be interested in the degree, results were nearly identical (see Figure 14).
Figure 14: Degree Appeals to Colleague (n=104) 42% 40%
17%
No Maybe Yes
16 Although there were more males (60%) than females (40%) in the sample, both genders reported not desiring the degree equally. By contrast, more female than males reported “maybe” considering the degree, but more males than females would be interested in the degree (see Figure 15)
Figure 15: Gender by Degree Appeal (n=104)
45% 45%
34% 33%
21% 21%
No Maybe Yes
Male Female
About one third of respondents fell into each age bracket in Figure 16. When comparing age bracket by degree appeal, no clear differences emerged (see Figure 17).
Figure 16: Age Brackets (n=104) 38% 35%
27%
1%
21-24 25-34 35-44 45-54
17 Figure 17: Age Bracket by Degree Appeal (n=103)
47% 46% 41% 39%
33% 31% 26% 22%
14%
25-34 35-44 45-54
No Maybe Yes
Nearly half of respondents possessed a Bachelor of Science degree. The remaining degrees are displayed in Figure 18.
Figure 18: Degrees of Respondents (n=104)
47%
13% 13%
7% 7% 8% 3% 2% 2%
BA BS MA MS MBA MD PharmD PhD Other
18 As with age, respondents’ educational attainment did not exhibit notable differences in preference for the DDPM degree (see Figure 19).
Figure 19: Educational Attainment by Personal Degree Appeal (n=102)
48% 43% 43% 39% 36% 35%
25% 22%
9%
No Maybe Yes
Bachelor Master Doctorate
The top two majors for respondents were Engineering and Biological Sciences (see Figure 20).
Figure 20: Majors of Respondents (n=104)
Engineering 35%
Biological Sciences 32%
Health 16%
Social Science 9%
Mathematical or Physical Science 7%
Humanities 2%
The top three industries for respondents were Health Services, Manufacturing, and Engineering (see Figure 21). Additionally, nearly all of respondents were employed full-time (94%), but most desired an internship as part of the program (76%).
19 Figure 21: Industries of Respondents (n=100)
Health Services 20%
Manufacturing 17%
Engineering 15%
Life Sciences and Biotechnology 14%
Pharmaceutical 11%
Academic or higher education 9%
Other 8%
Government Regulatory Agencies 4%
Managed Care 1%
Health Plans 1%
Nearly half of respondents had ten or more years of experience in their field (see Figure 22).
Figure 22: Years of Work Experience in Field (n=100)
49%
24%
13% 13%
1%
0 to 1 years 2 to 4 years 5 to 7 years 8 to 10 years 10+ years
As noted earlier, 40 percent of respondents expressed interest in the degree and 42 percent said “maybe”. The top three reasons respondents were interested in the degree included industry recognition of the degree, career advancement potential, and building industry connections (see Figure 23).
20 Figure 23: Reasons DDPM Degree is Appealing3 (n=45)
Industry would recognize and value degree 56%
Being able to advance in my industry/profession 53%
Building connections to industry and jobs 53%
Being able to transition to new industry/career 44%
Personal interest/enrichment 42%
Knowledge/skills gained would enhance my job 40% security
Will help secure future employment 38%
Improving performance or pay in current job or 36% field
Obtaining project management skills 33%
Interacting with instructors, classmates, 27% and networking
Gaining greater technical knowledge 0%
The top three reasons respondents were not interested in the DDPM degree included lack of time, lack of potential career advancement, and cost (see Figure 24).
3 Respondents could select more than one answer.
21 Figure 24: Reasons DDPM Degree is Not Appealing4 (n=25)
No time at this point in my career 36%
Do not think this degree will help me advance in my 36% industry/profession
Cost 24%
Do not think this degree will be valuable in my transition 20% to new industry/career
Do not think this degree would improve my pay in 20% current job or field
Do not believe knowledge/skills gained will enhance my 16% job security
Do not think this degree would improve my 16% performance
Masters not essential getting desired job 8%
Do not think this degree will help me in the future to get 4% employment
Do not think industry would recognize and/or value 4% degree
In deciding to pursue a DDPM degree, skill attainment and post-graduate occupational outlook were the most important factors (see Figure 25).
4 Respondents could select more than one answer.
22 Figure 25: Factors Influencing Enrollment Decision (n=82)
Skills/Knowledge learned 95%
Post-graduate occupational outlook 95%
Program's academic reputation 90%
Cost 88%
Length of program 83%
Personal attention from faculty 70%
Student support services 57%
Social environment 43%
23 For skills, respondents placed a higher value on biologics drug development, pharmacotherapy, project management, clinical trials development, and clinical regulatory submissions (see Figure 26).
Figure 26: Perceived Value of DDPM Skills (Skills rated Valuable or Extremely Valuable; n=104)
Biologics and biosimilars drug development 91%
Pharmacotherapy and diseases 89%
Project management 88%
Clinical trials development (Phase 0-3) 88%
Pre-clinical and clinical regulatory submissions and 88% strategy
Health outcomes evidence 86%
Product value and life cycle management 86%
Opportunities in pharma, biotech, and managed care 86%
Post-marketing drug utilization management 82%
Pharmaceutics for small molecules and macromolecules 82%
Business development, entrepreneurship, corporate and 80% intellectual property strategy
Marketing strategy 62%
Respondents were evenly split (50%) on desiring full-time or part-time enrollment. By contrast, they differed greatly on the format of the program, though most preferred a hybrid format (n=53; see Figure 27). When asked to specify the type of hybrid format, most preferred a mixture of in-person and online classes (n=44; see Figure 28). They could also select mostly online with a 2-week in-person networking or orientation component.
24 Figure 27: Format of Program5 (n=85)
62%
32%
20%
Traditional Hybrid Online
Figure 28: Preferred Type of Hybrid Format6 (n=56)
79%
45% 41%
2- week networking 2-week orientation In-person and online
5 Respondents could select more than one answer. 6 Respondents could select more than one answer.
25
Return on Investment (ROI) Framework
Pursuing a Master’s degree requires financial and time commitment. The research team developed a Return on Investment (ROI) framework to allow potential students to calculate the potential ROI on earning a Master’s degree for the proposed program. The ROI framework takes the following into consideration:
Current age Current age minus the number of years of work remaining (assuming 67 years old as retirement age). Current earning power Current income (or most probably income if not currently employed). Tuition cost to complete Master’s The cost to complete Master’s program (of the entire program length of program). University administrative fees, Administrative and miscellaneous fees charged by the health insurance, and other university. educational costs for Master’s program Living costs (net of employment Housing, food, and other living expense costs income) (particularly important if relocating for the program). Earning power after Master’s Potential salary after obtaining the proposed degree. program
The calculation assumes a student is enrolled in a full-time one-year program without working and does not contribute any funds to the program or living expenses. The framework takes into account loss income for the timeframe of the program. Calculations also assume students will complete loan repayment within 10 years (or 120 months). It is important to note that the ROI calculator is intended to show students the potential economic impact the master’s degree could have on their income over time. However, this is not to say that students could only achieve this type of ROI by enrolling in the proposed Master’s program. There are multiple variables that cannot be captured in a calculator such as experience, promotions, aptitude, and connectivity.
The following are examples of how ROI calculator could apply to the following target groups:
26 Career Advancer: Medical Scientist A 30-year-old medical scientist earning at the 25th percentile range of $57,820 could have an earning potential of $82,090 in the same existing role (assuming 50th percentile salary). The ROI calculator estimates that he or she would have a benefit of $717,784 until retirement at age 67 years. This is assuming that he or she borrows the entire tuition and living expenses costs, stays in the same post- degree role and does not assume a higher position with a different salary.
The student would have to allot 12 percent of their income to pay their student debt (based on the assumption costs below). Appendix B shows detailed calculations and assumptions.
Figure 29: Medical Scientist to Higher Percentile7 8 9
Factors Influencing ROI Cost Age 30 years Current earning power (most probable annual income) $ 57,820 Tuition cost to complete the program $ 42,000 Administrative fees, health ins., and other educational costs $ 5,500 Living costs (net of employment income) $ 24,633 Debt acquired for the program $ 98,115 Earning power after the program (most probable annual income) $ 82,090 Total Benefit $717,784 Monthly student debt payment as a percent of income 12%
7 Forbes rule of thumb: total student debt should not be more than annual earning power. 8 Government mortgage underwriting guideline: total debt payments not to exceed 43% of monthly income 9 Credit counselor guideline: 50% maximum of after-tax income on housing, insurance, transportation, food, and debt payments
27 Career Advancer The degree could be a good opportunity for more established individuals, as well. Assuming a 38-year old Medical and Health Services Manager earning a median salary of $98,350 stopped working for one year to pursue the degree full-time, they could potentially stay in the same existing role (assuming 75th percentile salary). They have the potential to earn an additional $660,614 until retirement at age 67 years old. This is assuming that he or she borrows the entire tuition and living expenses costs, stays in the same post-degree role and does not assume a higher position with a different salary.
The student would have to allot 8 percent of their income to pay their student debt (based on the assumption costs below). Appendix B shows detailed calculations and assumptions.
Figure 30: Medical and Health Services Manager to Higher Percentile10 11 12
Factors Influencing ROI Cost Age 38 Current earning power (most probable annual income) $ 98,350 Tuition cost to complete the program $ 42,000 Administrative fees, health ins., and other educational costs $ 5,500 Living costs (net of employment income) $ 24,633 Debt acquired for the program $ 98,115 Earning power after the program (most probable annual income) $ 128,960 Total Benefit $660,614 Monthly student debt payment as a percent of income 8%
10 Forbes rule of thumb: total student debt should not be more than annual earning power. 11 Government mortgage underwriting guideline: total debt payments not to exceed 43% of monthly income 12 Credit counselor guideline: 50% maximum of after-tax income on housing, insurance, transportation, food, and debt payments
28 Appendix A
Competitor Programs
The following table contains all the programs that were reviewed for possible competitiveness. Because several programs did not have all three themes (e.g., Business, Regulation, and Natural Sciences), several were excluded. Only the programs highlighted in blue were evaluated in this report.
29 Degree Natural Institution Name of Degree Type Business Regulatory Sciences Arizona State University Clinical Research Management, Regulatory Science MS No Yes No Campbell University School of Pharmacy Clinical Research MS No Yes Yes CUNY York College Pharmaceutical Science and Business MS Yes Yes Yes Drexel Clinical Research Organization and Management MS Yes Yes No Drexel Clinical Research for Health Professionals MS No Yes No Drexel Drug Discovery and Development MS Yes Yes Yes George Washington U Health Sciences in Regulatory Affairs MS No Yes No John Hopkins U Biotechnology, concentration Regulatory Affairs MS No Yes No John Hopkins U Bioscience Regulatory Affairs MS No Yes No Keck Graduate Institute Bioscience, emphasis in Clinical Regulatory Affairs MBS Yes Yes Yes Long Island U, College of Pharmacy Science, specialization in drug regulatory affairs MS No Yes No Long Island U, Liu Pharmacy Drug Regulatory Affairs MS No Yes No Massachusetts College of Pharmacy Drug Regulatory Affairs and Health Policy MS No Yes No Massachusetts College of Pharmacy Clinical Research MS No Yes Yes Northeastern U, School of Professional an Regulatory Affairs MS Yes Yes No Northeastern U, School of Professional an Biotechnology MS Yes Yes Yes Northwestern U School of Continuing StudQuality Assurance and Regulatory Sciences MS Yes Yes No Northwestern U School of Continuing StudClinical Research and Regulatory Administration MS Yes Yes No Ohio State U Master of Applied Clinical and Preclinical Research MS No Yes Yes Regis College Regulatory and Clinical Research Management MS No Yes No Rutgers, State U of NJ Business and Science, Drug Development concentration MBS Yes Yes Yes Rutgers, State U of NJ Clinical Trial Science MS Yes Yes Yes San Jose State University Medical Product Development Management MS Yes Yes No SDSU Regulatory Science MS Yes Yes No
30 Degree Natural Institution Name of Degree Type Business Regulatory Sciences St. Cloud State U Regulatory Affairs and Services, focus on medical devices MS No Yes No St. Cloud State U Applied Clinical Research, for Industry MS No Yes No St. John's U Pharmacy Administration, specialization in Pharmaceutical MPA Yes Yes No Temple U Quality Assurance/Regulatory Affairs MS No Yes Yes U of Cincinnati Pharmaceutical Sciences with Drug Development SpecializaMS No Yes Yes U of Florida, College of Pharmacy Pharmacy, concentration in Pharmaceutical Regulation MS Yes Yes No U of Maryland Regulatory Science MS No Yes Yes U of Maryland Biotechnology, concentration Regulatory Affairs MS No Yes No U of N. Carolina Wilmington Clinical Research and Product Development MS No Yes No U of Pennsylvania Regulatory Affairs MRA No Yes No U of Pennsylvania Regulatory Science MS No Yes No U of Rhode Island Pharmaceutics and Pharmacokinetics MS No Yes Yes U of St. Thomas Regulatory Science MS Yes Yes No U of Washington Biomedical Regulatory Affairs MS No Yes No USC Regulatory Science MS Yes Yes Yes USC Management of Drug Development MS Yes Yes Yes USC Medical Product Quality MS Yes Yes Yes Yeshiva U Biotechnology Management and Entrepreneurship MS Yes Yes No INTERNATIONAL Danube U Krems EU Regulatory Affairs MS Yes Yes No U College London Drug Discovery and Development MSc No No Yes U College London Msc Drug Discovery and Pharma Management MSc Yes No Yes U College London Drug Delivery ( in Pharmaceutics) MSc Yes No Yes U of Hertfordshire Regulatory Affairs MS No Yes Yes U of Huddersfield Drug Discovery and Business Strategy MS Yes No Yes U of Manchester Pharmaceutical Industrial Advanced Training MSc Yes Yes Yes
31 Appendix B Graduate ROI Framework – Medical Scientist (Figure 29 Calculations)
Current Age 30 Assume retiring at age: 67 Years of work remaining (minus length of program): 36
Living costs (net of employment income) (12 months) $24,633 (assumes 12 months)
Program Tuition $42,000 Administrative fees, health ins., and other edu. costs (4 quarters) $5,500 Books and supplies $1,514
Total loan $73,647 Interest 6%
Total amount due after 10 years $98,115.92 Income net of debt payments over 10 years Monthly student debt payment as a percent of income 12% Assumed payment period: 120 months
Current earning power $57,820 Current monthly income $4,818.33
Time frame to complete program (years) 1.0 Monthly loan payment 817.63
Earning power after the program (most probable annual income) $82,090 Expected monthly income $6,840.83
New monthly income minus Total salary of old income (raw) $2,081,520 loan payment $6,023.20 Total salary with new income (minus tuition cost and salaries lost for program time) $2,799,304
Additional income net of debt Calculated additional financial benefit of the program $717,784 payments over 10 years Monthly benefit after loan payment complete 2,300.59 Assumed payment period: 120 months
32 Graduate ROI Framework – Medical and Health Services Manager (Figure 30 Calculations)
Current Age 38 Assume retiring at age: 67 Years of work remaining (minus length of program): 28
Living costs (net of employment income) (12 months) $24,633 (assumes 12 months)
Program Tuition $42,000 Administrative fees, health ins., and other edu. costs (4 quarters) $5,500 Books and supplies $1,514
Total loan $73,647 Interest 6%
Total amount due after 10 years $98,115.92 Income net of debt payments over 10 years Monthly student debt payment as a percent of income 8% Assumed payment period: 120 months
Current earning power $98,350 Current monthly income $8,195.83
Time frame to complete program (years) 1.0 Monthly loan payment 817.63
Earning power after the program (most probable annual income) $128,960 Expected monthly income $10,746.67
New monthly income minus Total salary of old income (raw) $2,753,800 loan payment $9,929.03 Total salary with new income (minus tuition cost and salaries lost for program time) $3,414,414
Additional income net of debt Calculated additional financial benefit of the program $660,614 payments over 10 years months Monthly benefit after loan payment complete 3, 058.40 Assumed payment period: 120
33 Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix C: Scoring Template Appendix C: Scoring Template for the MS in Drug Development and Product Management Student Name
UC San Diego MS IN Drug Development Product Management Total Points MS DDPM Admissions Scoring Template PART ONE PART TWO Grades, as measured by most recent GPA from a recognized institution, Relevant education and experience, as communicated based on a four‐point grading scale (select one): by their CV/resume and the responses on their application Points Available Candidate Score Points Candidate 3.71-4.0 (A or A+) 40 Degree (select one) Available Score 3.4-3.7 (A-) 35 ‐ US medical degree 10 3.1-3.3 (B+) 30 ‐ foreign medical or science doctoral degree 8 2.71-3.0 (B) 25 ‐ relevant US graduate degree 7 2.5-2.7 (B-) 20 ‐ US bachelors degree, or any graduate degree 5 2.3-2.5 (C+) (2.3= C+) 15 2.0- 2.29 ( C ) 10 Less than a 2.0 0 pts Clinical experience (select one) Optional points from other coursework 3+ years direct work 9 Concurrent Enrollment in UCSD MAS: MD program or less than 3 years direct work 5 ‐ A or A minus average 10 More than 3 years direct work 5 ‐ B or B plus average 5 less than 3 years (or no) direct work 2 Courses from accredited US universities ‐ A or A minus average 5 Research Experience (select one) ‐ B or B plus average 2.5 3+ years PI 6 Courses from other institutions Less than 3 years PI 4 ‐ A or A minus average 2.5 5+ years associate 4 Poor work in very relevant class(es) Less than 5 years associate 2 C or lower grade -5 Research Administrator 2
Total (40 maximum) 40 Total Maximum (25 points) 25
*PART THREE **PART FOUR Recommendations, as indicated by letter, or personal Personal Preparation, as indicated by statement of endorsement by the UCSD faculty purpose, and supplemental interview if necessary
Articulation of student characteristics and Articulation of achievable and meaningful achievements which instill confidence of success up to 15 professional outcomes from the program up to 9 up to 5 Relevant and responsible title(s) of recommenders Articulation of specific & appropriate research interest (s) up to 6 Total (20 Maximum) 20 Total (15 maximum) 15
NOTE: English proficiency is a separate requirement for admission. Individuals for whom English is not their first language must achieve a TOEFL score of 82 (online) or 550 (paper). The score may be waived in lieu of a personal interview or successful USMLE score. Appendix C: Scoring Template for the MS in Drug Development and Product Management
*Scoring for Each Letter of Recommendation (LOR): • 5 PTS= Research specific, job specific, personal and well thought out • 4PTS= States Student Passion, field of interest, describes type of work • 3PTS= Describes student characteristics and personality • 1-2PTS= copy of generic letter and/or minimal written.
**Scoring for Statement of Purpose (SOP): Describe career goals and outcomes of the program, why do they need this degree- Describe the type of research they are interested in- Describe why they are passionate about research- Discuss the types of fields they are interested in studying- Touch on past experience or lack thereof- Students can get up to 15 points for the SOP Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix D: Course Approval Forms
DDPM-200R - Opportunities in Pharma, Biotech and Managed Care (Ettouati, W.)
DDPM-201R - Pharmacotherapy and Diseases (Yam, F)
DDPM-202R - Pharmaceutics for Small Molecules and Macromolecules (Best, B., Reed, C.)
DDPM-203R - Pre-Clinical and Clinical Regulatory Submissions and Strategy (Momper, J)
DDPM-204R - Clinical Trial Development from Phase 0 to Phase 3 Studies (Ma, J.)
DDPM-208R - Principles of Marketing Strategy, Product Value, and Life Cycle Management (Doshi, D.)
DDPM-210R - Biologics and Biosimilars Drug Development (Chen, H., Vande-Casteele, N., Ma, J.)
DDPM-211R - Managed Markets - Post Marketing Drug Utilization Management (Forrester, C., Wong, F.)
DDPM-213R - Health Outcomes Evidence (Cuomo, R.)
DDPM-214R - Business Development & Entrepreneurship, Corporate & Intellectual Property Strategy (Ettouati, W., Nguyen, C., Evans, W.)
UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-200R 1 Opportunities in Pharma, Biotech and Managed Care Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 1 2 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) Students will learn and hear from industry executives about the wide range of career opportunities that exists from clinical trials to managed markets. In addition, the course will teach how to create a personal strategic and tactical career plan and introduce skill sets that will form a foundation for students to apply and hone throughout the curriculum.
Prerequisites: Student in Online MS-Drug Development Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in Online MS-Drug Development & Product Management program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Williams Ettouati, PharmD, Managing Director, Associate Clinical Professor, SSPPS
JUSTIFICATION: Required course in MS-Drug Development Product & Management Program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-201R 3 Pharmacotherapy and Diseases Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 3 6 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course provides students an introduction to pharmacotherapy concepts and essential considerations in new drug design, drug development, and clinical trials, enabling future managers to guide efforts in drug discovery.
Prerequisites: Student in MS-Drug Development Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Yam, Felix, Pharm.D., M.A.S., BCPS, BCCP, Associate Clinical Professor of Pharmacy, SSPPS
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
New Course Reinstatement ✔ Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-202R 4 Pharmaceutics for Small Molecules and Macromolecules Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course will introduce students to the scientific and clinical principles influencing drug exposure and response, along with commercial factors considered when developing drug candidates into therapeutic products. Application of pharmaceutics principles allows the safe and effective use of medications in patients.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Brookie Best, PharmD, MAS, Professor of Clinical Pharmacy and Pediatrics, SSPPS and Dept. of Pediatrics, UC San Diego-Rady Children’s Hospital San Diego. Chantal Reed, PhD, Volunteer Faculty SSPPS JUSTIFICATION: Required course in MS-Drug Development Product Management Program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-203R 4 Pre-Clinical and Clinical Regulatory Submissions and Strategy Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course provides an overview of the common regulatory filings during pre-clinical and clinical development. Using a case study format, the student will gain an understanding of the regulations governing pharmaceutical and biologic products in the United States and globally.
Prerequisites: Student in MS-Drug Development &Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Jeremiah D. Momper, Pharm.D., PhD; Asst. Clinical Professor, SSPPS
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-204R 4 Clinical Trial Development from Phase 0 to Phase 3 Studies Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) Students will learn the process of drug development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Joseph D. Ma, Pharm.D.; Clinical Professor, SSPPS
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year ✔ Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-208R 4 Principles of Marketing Strategy, Product Value & Life Cycle Management Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) Using multiple case studies and real-world examples, this course describes the complexity of today’s product management in a global drug development effort. This course will provide an overview of international pharmaceutical marketing and principles for cost-effective analysis.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Dilesh Doshi, PharmD, Volunteer Faculty and Senior Director, Population Health Research, Janssen Scientific Affairs
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-210R 4 Biologics and Biosimilars Drug Development Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course explains how biologics are developed and commercialized as therapeutics, explores how the process differs from the traditional pharmaceutical approach for small molecules, and outlines the challenges and opportunities for producing more affordable generic equivalents, also known as biosimilars.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Joseph D. Ma, Pharm.D; Clinical Professor, SSPPS; Hubert C. Chen, MD; Project Scientist, Department of Bioengineering; Niels Vande Casteele, PharmD, PhD, Dept. of Medicine, SOM JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-211R 4 Managed Markets – Post Marketing Drug Utilization Management Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course provides an overview of Drug Utilization Management structures and techniques in both U.S. Public and Private Sectors. Practices in Formulary Management, Contracting for Product Placement, Pricing Strategies, Positioning to Gain Market Share and the Impact of Public Policy on Product Utilization are to be covered.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: John Jones, RPh, JD, FAMCP, Volunteer Faculty and President and CEO of JDJ-RPhJD Consulting, Inc
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
✔ New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-213R 4 Health Outcomes Evidence Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) This course examines the breadth of data and study types that build evidence of a product’s value from potential estimates during the early development stages through to post marketing actual value realized over time in various populations.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Raphael Cuomo, PhD, MPH, CPH, FRSPH, Research Scientist, UC San Diego
JUSTIFICATION: Required course in MS-Drug Development & Product Management program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) UNIVERSITY OF CALIFORNIA, SAN DIEGO REQUEST FOR COURSE APPROVAL
New Course Reinstatement Deletion Renumbering: old number______Summer Session Only Effective Quarter Year ✔ Change In Course Nature of Change: FALL 2021
Subject & Number Units Title DDPM-214R 4 Corporate, IP and Business Development Strategy and Entrepreneurship Hours Per Week Lec Sem Dis Lab Studio Practicum PE Act Med Clerk Outside Prep Other (describe) Expected of Student 4 8 If the course has multiple discussion or other sections, how should the grade reports be printed (check one)? ✔ Single List of all students By Dis Section By Lab Section By Studio Section By Tut Section
Grading - Undergraduate Standard Grading (letter or P/NP) P/NP Only
Grading – Graduate and SOM ✔ Standard Option (Graduate) S/U Permitted S/U Only H/P/F (SOM Core only)
May be taken for credit ______1 time(s). If more than once, justify:
✔ Final Exam Given If not, explain:
COURSE DESCRIPTION (In concise catalog description style, 40 word limit) Using multiple case studies and real-world examples, this course will describes the complexity of business development and the process of deal making within the pharmaceutical and biotech industries. In addition it will examine key concepts regarding corporate law and patents as it pertains to the pharmaceutical industry.
Prerequisites: Student in MS-Drug Development & Product Management program or permission of department ENFORCEMENT List prerequisites and other restrictions to be enforced by computer (see instructions).
Prerequisites that must be completed:
Prerequisites that may be concurrent:
Corequisites (must be concurrent):
Other restrictions: Student in MS-Drug Development & Product Mgmt. program or permission of dept.
Special course characteristics. Check all boxes that apply and see instructions for required explanations. Use of animals Use of computer resources IP Grading Cross listed with ______Conjoined with ______
Instructor and title: Williams Ettouati, PharmD, Managing Director, Associate Clinical Professor, SSPPS
JUSTIFICATION: Required course in MS-Drug Development & Product Management Program
______Program Director date Registrar date
APPROVALS – GRADUATE COURSE APPROVALS - UNDERGRADUATE COURSE
______Dean, Skaggs School of Pharmacy date ______and Pharmaceutical Sciences Council of Provosts date
______Dean of Graduate Studies date ______CEP Subcommittee on Courses date
______Graduate Council date
Extent of approval: Indefinite Summer Only Expires at the end of ______quarter, 20____
FO 2073 (REV. 7/90) Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix E: Financial Projections/Cost Analysis CONTACT Unit SSPPS and administered by Extension
Principal Faculty Name Williams Ettouati, PharmD Date 3/18/2019
PROPOSITION OVERVIEW
Type of Offering Online Masters Degree Delivery Format Online
Planned Start Date 09/15/20
Title of Offering MS in Drug Development and Product Management (online)
Planned enrollment # of Cohorts Time to Completion 12 months @ steady state 125 1 (of degree, cert., course)
Target Market Working professionals from either scientific, medical Total No. Courses 10 Units per course pharmaceutical, business management or legal backgrounds, Total Units 36 who need specialized drug development and product 1) modified courses 8 4 management skills for career opportunities and advancement 2) modified course 1 1 in pharmaceutical and managed care industries or related 3) modified course 1 3 government agencies.
REVENUE FINANCIAL SUMMARY Year 1 Year 2 Year 3 Year 4 Year 5 Sep-20 Sep-21 Sep-22 Sep-23 Sep-24 FTE Enrollment; Tuition & Fees Average Program Enrollment 65 75 110 110 125 Tuition/Fees Tuition $ 27,120 $ 27,120 $ 28,371 $ 28,371 $ 29,632 Other Fees, if applicable - - - - - Total Tuition/Fees $ 27,120 $ 27,120 $ 28,371 $ 28,371 $ 29,632
Revenue Tuition Revenue $ 1,762,800 $ 2,034,000 $ 3,120,810 $ 3,120,810 $ 3,704,001 Flow-through Student Fees 136,500 157,500 231,000 231,000 262,500 Program Specific Fee Total Revenue for Distribution $ 1,626,300 $ 1,876,500 $ 2,889,810 $ 2,889,810 $ 3,441,501 Revenue Share Model Student Financial Aid 10% 10% 10% 10% 10% Campus 11% 22% 33% 33% 33% Dean 7% 7% 7% 7% 7% Academic Unit 72% 61% 50% 50% 50%
EXPENSE FINANCIAL SUMMARY Year 1 Year 2 Year 3 Year 4 Year 5 Sep-20 Sep-21 Sep-22 Sep-23 Sep-24 Revenue to Academic Unit $ 1,170,936 $ 1,144,665 $ 1,444,905 $ 1,444,905 $ 1,720,751 Direct Costs paid by: Unit Unit Unit Unit Unit Instruction (LRF, Lect), including benefits 126,000 126,000 132,300 132,300 138,915 T.A. support, including benefits 130,000 150,000 231,000 231,000 275,625 Program Leadership/Committees (faculty) 182,000 182,000 191,100 191,100 200,655 Student Advising 112,500 140,625 144,844 149,189 153,665 Career Services 28,125 30,938 31,866 32,822 33,806 Marketing (incl year 0 website dev & 140,000 74,160 76,385 78,676 81,037 launch marketing campaigns) Student Recruitment 56,250 70,313 72,422 74,595 76,832 General Operations (S&E, travel, 90,500 113,125 116,519 116,519 120,014 technology, class materials, etc.) New Course Content Development 140,000 (faculty time) Offering Refresh (faculty time) 46,200 46,200 46,200 46,200 OL Course Development/Video 100,000 100,000 Update (Tech) Other Offering-Specific Costs 100,000 100,000 100,000 100,000 100,000 (Virbella or comparable) Total Direct Costs (TDC) $ 1,105,375 $ 1,033,360 $ 1,242,635 $ 1,152,400 $ 1,326,749 Development Costs paid by: Campus New course and content 14,000 Modify existing course content Convert courses to online 400,000 Extraordinary costs not captured elsewhere 10,000 (preliminary market analysis) Total Development Costs $ 424,000 Annual Contribution to Unit Operations $ 65,561 $ 111,305 $ 202,270 $ 292,505 $ 394,001 Cumulative Contribution to Unit Operations $ 176,866 $ 313,575 $ 494,775 $ 686,506 Total Cost of Instruction per SFTE $ 17,006 $ 13,778 $ 11,297 $ 10,476 $ 10,614
END OF FORM
SAPD_Financial_Model.DDPM-MS-OL.36_UNITS.xlsx Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix F: Letters of Endorsement Faculty Committees:
SSPPS Committee on Educational Policy (CEP)
Health Sciences Faculty Council (HSFC)
UC San Diego:
Dr. David Brenner, Vice Chancellor, Health Sciences
Dr. James McKerrow, Dean, Skaggs School of Pharmacy and Pharmacological Sciences
Dr. Michael Gilson, Co-Director, UC San Diego Center for Drug Discovery Innovation
Dr. Karen Flammer is the Director of Digital Learning at UC San Diego
Industry:
Althea, Inc
Biocom
Pfenex, Inc.
Pfizer, Inc.
Scripps Research Translational Institute
Ventegra, Inc.
Additional letters from the 2016 Proposal for the MS in Drug Development and Product Management classroom-based degree program attached: • SSPPS Committee on Educational Policy (CEP) • Health Sciences Graduate Professional Educational Council (GPEC) • Health Sciences Faculty Council (HSFC) • Dr. Avid Brenner, Vice Chancellor, Health Sciences • Dr. Joan Heller, UC San Diego Department of Pharmacology • Dr. Gary Firestein, Director, Clinical and Translational Research Institute • Dr. Razelle Kurzrock, Moores Cancer Center • Center for Drug Discovery and Innovation, UC San Diego • Arena Pharmaceuticals • Biocom • Johnson and Johnson Innovation • Pfenex, Inc • Pfizer Oncolocy
February 13th, 2019
To: Giovanna Casola, MD Chair, Health Sciences Faculty Council (HSFC)
From: Pieter Dorrestein, PhD Co-chair, SSPPS Committee on Educational Policy (CEP)
Dear Dr. Casola,
Subject: Request for Letter of Endorsement by HS Faculty Council for Online Masters of Science (MS) degree in Drug Development and Product Management (DDPM)
On behalf of the SSPPS CEP and the support of Dr. James McKerrow, Dean of SSPPS, we request that the HSFC endorse the online MS degree in Drug Development and Product Management (DDPM). The current, in-person MS degree in DDPM is being taught at SSPPS (www.ddpm.ucsd.edu) and has been approved by HSFC (April 6th, 2016), SSPPS CEP, UCSD campus and UCOP.
The DDPM program is changing the delivery of the program to be online. With the online program, there will no longer be an internship practicum which is currently required for the in-person MS degree.
At our February 1st, 2019 meeting, the SSPPS CEP approved the transition of the current, in-person MS degree to an online MS degree.
~ ~ UC San Diego HEALTH SCIENCES
March 7, 2019
WILLIAM S. ETTOUATI, PHARM.D. Director, Strategic Academic Program Development Support Team Director, Industrial Relations and Development Associate Director, Center for Drug Discovery Innovation Skaggs School of Pharmacy and Pharmaceutical Sciences MC 0714
Subject: Proposal for Master in Drug Development and Product Management - Online Delivery
Dear Dr. Ettouati:
I am pleased to inform you that the Health Sciences Faculty Council (HSFC) has voted unanimously to endorse the proposal to pursue the development of a Master in Drug Development and Product Management - Online Delivery in the Skaggs School of Pharmacy and Pharmaceutical Sciences.
The HSFC thanks you for presenting at the March 5, 2019 meeting. We wish you success as you continue your efforts in creating this program.
Sincerely,
~~ Giovanna Casola, M.D. Chair, Health Sciences Faculty Council c: David A. Brenner, Vice Chancellor, Health Sciences J. McKerrow, Dean, SSPPS
HEALTH SCIENCES fACULTY COUNCIL 9500 Gilman Drive, MC 0602 San Diego, California 92093-0602 TEL: (858) 822-3855 FAX: (858) 534-1405
UC San Diego Health March 22, 2019 Office of the Vice Chancellor for Health Sciences 9500 Gilman Drive #0602 Graduate Council La Jolla, CA 92093-0602 UC San Diego – Academic Senate T: 858.534.1501 F: 858.534.6573 MC 0002 https://healthsciences.ucsd.edu/ SUBJECT: Master in Science in Drug Development and Product Management
David A. Brenner, MD Dear Graduate Council, Vice Chancellor for Health Sciences
Distinguished Professor of As Vice Chancellor for Health Sciences at the University of California Medicine San Diego, I am pleased to endorse the online delivery of the approved Master of Science Program in Drug Development and Product Management and supports its efforts.
Sincerely,
David A. Brenner, MD
February 7, 2019
Sonia Ramamoorthy, MD Chair, Health Sciences Faculty Council Chief, Colon and Rectal Surgery Professor of Surgery
Dear Dr. Ramamoorthy,
Subject: Request for Letter of Endorsement by HS Faculty Council for Online Masters of Science (MS) degree in Drug Development and Product Management (DDPM)
As Associate Vice Chancellor for Health Sciences and Dean of Skaggs School of Pharmacy & Pharmaceutical Sciences (SSPPS) at the UC San Diego, I have discussed the plan of an online MS degree in Drug Development and Product Management (DDPM) with the program directors.
The MS DDPM program previously obtained unanimous approval by the Health Sciences Faculty Council as a new, live, in-person MS degree. Documentation of approval was provided to Williams Ettouati, PharmD on April 6th, 2016 by then Chair, Dr. Bob Carter.
The online program is being proposed SSPPS and has been approved by the SSPPS Committee on Education Policy (CEP). I am pleased to endorse this program and am hopeful its review can be added to the March agenda for the Health Science Faculty Council.
Sincerely yours,
James H. McKerrow, PhD, MD Dean, Skaggs School of Pharmacy & Pharmaceutical Sciences Associate Vice Chancellor of Health Sciences
Skaggs School of Pharmacy & Pharmaceutical Sciences UC San Diego • 9500 Gilman Drive, # 0657 • La Jolla, CA 92093 T: 858-822-7801 • F: 858-822-5591 • [email protected] • pharmacy.ucsd.edu
Williams S. Ettouati, PharmD Director, Strategic Academic Program Development Support Team Director, Industrial Relations & Development Associate Director, Center for Drug Discovery Innovation Health Sciences Associate Clinical Professor, N.S. Skaggs School of Pharmacy & Pharmaceutical Sciences University of California San Diego 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
February 27, 2019
Dear Williams,
As a professor of pharmacy and co-director of UC San Diego’s Center for Drug Discovery Innovation, I am delighted to write in support of your proposed online Health Sciences Master of Science (MS) in Drug Development and Product Management (DDPM).
Your development and implementation of the current in-person MS DDPM program, conducted at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, is truly an impressive and significant accomplishment. This program fulfills a hitherto unmet need in the local pharma/biotech sector for a route to advance the expertise and careers of working professionals in this important field. By providing state-of-the art education in drug development and project management, it promotes economic growth. And you have created and modeled a new revenue stream for our university.
With the in-person program fully operational, you now have a strong foundation to extend your reach to a much broader student community online. Indeed, today’s web-based classes make it possible to teach students worldwide. This is a major opportunity, given the many centers of pharma/biotech research in places like San Francisco; Cambridge, MA; New Jersey; and cities in Europe, Japan, China and India. In addition, the on-line format will provide greater time-flexibility, which is important to students who are already in the industry. Extending the DDPM program online will also benefit UC San Diego, by generating additional revenue and by giving us greater visibility in the pharma/biotech space. It is perhaps worth noting that other major universities, such as Harvard and MIT, are also exploring and taking advantage of the worldwide web to reach an expanded student population. Your proposal clearly advances the mission of the University of California. For these reasons, I enthusiastically endorse your plan to create a UC San Diego online MS DDPM program. Sincerely yours,
Michael K. Gilson, MD,PhD Professor and Chair in Computer-Aided Drug Design Co-Director, UC San Diego Center for Drug Discovery Innovation Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive, MC La Jolla, California 92093-0736 858-822-0622 [email protected]
DR. KAREN FLAMMER DIRECTOR, DIGITAL LEARNING TEACHING + LEARNING COMMONS 9500 GILMAN DRIVE #0175-W LA JOLLA, CALIFORNIA 92093-0175
March 26, 2019
Subject: Skaggs School of Pharmacy and Pharmaceutical Sciences – Online Master’s Degree in Drug Development and Product Management (DDPM)
To: UC San Diego Academic Sentate
I fully support the proposed online master’s degree program in Drug Development and Product Mangement. Digital Learning and the Teaching + Learning Commons look forward to working closely with the DDPM faculty to ensure the highest quality degree program.
Furthermore, in order to provide a measure of consistent quality for online courses, UC San Diego is a subscribing member to Quality Matters TM , a world recognized quality assurance organization for online learning. The Digitial Learning team will utilize the Quality Matters Rubric to guide course design and facilitate final course reviews.
Sincerely,
Karen Flammer, Ph.D. [email protected] 858.245.2715 digitallearning.ucsd.edu
TtI MAKE
A MEMBER OF THE AJINOMOTO GROUP
Williams S. Ettouati, PharmD. February 19th,2019 Strategic Academic Program Development Support Team Director, Industrial Relations & Development Associate Director, Center for Drug Discovery Innovation Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla CA92093-0714
Dear Williams,
I am pleased to write a letter of support for the online Health Sciences Master of Science (MS) in Drug Development and Product Management (DDPM).
Congratulations on the success of the current in-person MS DDPM progr:rm being conducted at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. The current progftun is meeting the needs of providing an educational foundation in drug development product management, and entrepreneurship. In addition, this program is well designed to provide working professional students unique skills that can be applied in developing his/trer knowledge and improving hiVher career in the pharmaceutical, biotech or managed care industries.
One of the limitations of the current in-person program is that potential domestic and international students who would benefit from such a program aren't in a position to enroll full-time at a residential program- The majority of students that would benefit from such a progzun do not reside in San Diego; the pharmaceutical and biotech industry hubs are located in Cambridge, San Francisco, New Jersey and around the world in Europe, Japan, India and China.
As a serial entrepreneur in life sciences with a background in drug development, I am very familiar with the needs of the industry in this area. Although our region has a stellar reputation in basic sciences education, there is a gaping hole in the training in drug development and product management. I believe UC San Diego is the ideal place to pave the way for a graduate program in this field.
In order to reach an ever-expanding student base and implement technolory in the education of students, the transition of the curent in-person program to an online program is critical for the MS DDPM to be successful, sustainable, and fully self-funded. An online prograrn would allow students to gain new skills and advance in their sareer while balancing existing professional and personal duties.
Finally, I believe that the transition to an online MS DDPM program will greatly benefit the campus, and the global community at large.
Magda Marqueg Ph.D. co-Founder & Chairman of the Board
11040 Rosette Street E: contactOAttheaCM0.com OTO ALTHE San Diego, C492121 www.AttheaCM0.com
February 13, 2019
Williams S. Ettouati, PharmD Director, Strategic Academic Program Development Support Team Director, Industrial Relations & Development Associate Director, Center for Drug Discovery Innovation Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams,
I am pleased to write a letter of support for the online Health Sciences Master of Science (MS) in Drug Development and Product Management (DDPM).
Congratulations on the success of the current in-person MS DDPM program being conducted at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. The current program is meeting the needs of providing an educational foundation in drug development, product management, and entrepreneurship. In addition, this program is well designed to provide working professional students unique skills that can be applied in developing his/her knowledge and improving his/her career in the pharmaceutical, biotech or managed care industries.
One of the limitations of the current in-person program is that potential domestic and international students who would benefit from such a program aren’t in a position to enroll full-time at a residential program. The majority of students that would benefit from such a program do not reside in San Diego; the pharmaceutical and biotech industry hubs are located in Cambridge, San Francisco, New Jersey and around the world in Europe, Japan, India and China. In order to reach an ever-expanding student base and implement technology in the education of students, the transition of the current in-person program to an online program is critical for the MS DDPM to be successful, sustainable, and fully self-funded. An online program would allow students to gain new skills and advance in their career while balancing existing professional and personal duties. Finally, I believe that the transition to an online MS DDPM program will further expand the role of UCSD in the global community.
Sincerely,
Hubert C. Chen, M.D. Chief Medical Officer, Metacrine Inc. Scientific & Medical Advisor, Pfenex Inc. 3985 Sorrento Valley Blvd, Suite C San Diego, CA 92121 [email protected]
February, 18, 2019
Williams S. Ettouati, PharmD Director, Strategic Academic Program Development Support Team Director, Industrial Relations & Development Associate Director, Center for Drug Discovery Innovation Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams,
I am pleased to write a letter of support for the online Health Sciences Master of Science (MS) in Drug Development and Product Management (DDPM).
Congratulations on the success of the current in-person MS DDPM program being conducted at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. The current program is meeting the needs of providing an educational foundation in drug development, product management, and entrepreneurship. In addition, this program is well designed to provide working professional students unique skills that can be applied in developing his/her knowledge and improving his/her career in the pharmaceutical, biotech or managed care industries.
One of the limitations of the current in-person program is that potential domestic and international students who would benefit from such a program aren’t in a position to enroll full-time at a residential program. The majority of students that would benefit from such a program do not reside in San Diego; the pharmaceutical and biotech industry hubs are located in Cambridge, San Francisco, New Jersey and around the world in Europe, Japan, India and China. Majority of potential candidates seeking further training to take the next step towards a more advanced position in their career are today in a full time employment not being able to attend educational sessions during their working hours. While majority of institutions and pharma companies in the US provide financial educational assistance to their employees, the major obstacle to pursue a formal degree is to attend in-person classes during normal work hours. In order to reach an ever-expanding student base and implement technology in the education of students, the transition of the current in-person program to an online program is critical for the MS DDPM to be successful, sustainable, and fully self- funded. An online program would allow students to gain new skills and advance in their career while balancing existing professional and personal duties.
Finally, I believe that the transition to an online MS DDPM program will greatly benefit the campus, and the global community at large.
Sincerely,
Kourosh Parivar, M.Pharm. VP & Head, Clinical Pharmacology, Oncology Global Product Development, Pfizer Inc. 10555 Science Center Drive San Diego, CA 92121
Amalio Telenti, MD, PhD 10550 North Torrey Pines Road La Jolla, California 92037 Mail SGM 300 Tel 858-784-2028 Cell: 858-232-4424 e-mail: [email protected]
February 14, 2019
Williams S. Ettouati, PharmD Director, Strategic Academic Program Development Support Team Director, Industrial Relations & Development Associate Director, Center for Drug Discovery Innovation Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams,
I am pleased to write a letter of support for the online Health Sciences Master of Science (MS) in Drug Development and Product Management (DDPM).
Congratulations on the success of the current in-person MS DDPM program being conducted at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. The current program is meeting the needs of providing an educational foundation in drug development, product management, and entrepreneurship. In addition, this program is well designed to provide working professional students unique skills that can be applied in developing his/her knowledge and improving his/her career in the pharmaceutical, biotech or managed care industries.
I am well positioned to comment on this need in the biotech and pharmaceutical environment as I have held positions in both the academic and corporate worlds. There is a critical need to maintain training in general, cross-field education, and training that supports transition from academia to industry and that enhances entrepreneurial skills.
Your inhouse program is successful, both in participation and in the international footprint. However, one of the limitations of the current in-person program is that potential domestic and international students who would benefit from such a program aren’t in a position to enroll full-time at a residential program. The majority of students that would benefit from such a program do not reside in San Diego; the pharmaceutical and biotech industry hubs are located in Cambridge, San Francisco, New Jersey and around the world in Europe, Japan, India and China.
In order to reach an ever-expanding student base and implement technology in the education of students, the transition of the current in-person program to an online program is critical for the MS DDPM to be successful, sustainable, and fully self-funded. An online program would allow students to gain new skills and advance in their career while balancing existing professional and personal duties.
Finally, I believe that the transition to an online MS DDPM program will greatly benefit the campus, and the global community at large.
Sincerely,
Amalio Telenti, MD, PhD Chief Data Scientist Scripps ResearchTranslational Institute
PROPOSAL FOR A MASTER OF SCIENCE DEGREE IN DRUG DEVELOPMENT AND PRODUCCT MANAGEMENT
Appendix F: Letters of Endorsement
Faculty Committees SSPPS Committee on Educational Policy (CEP)
Health Sciences Graduate Professional Education Council (GPEC)
Health Sciences Faculty Council (HSFC)
Industry Arena Pharmaceuticals
Biocom
Johnson and Johnson Innovation
PFEnex.inc
Pfizer Oncology
UC San Diego Dr. David Brenner, Vice Chancellor, Health Sciences
Dr. Gary Firestein, Director, Clinical and Translational Research Institute
Dr. Joan Heller Brown, UCSD Department of Pharmacology
Center for Drug Discovery and Innovation
Moores Cancer Center 4 March, 2016
To: Bob Carter, MD, Ph.D. Chair, Health Sciences Faculty Council
From: Shirley Tsunoda, Pharm.D. William Gerwick, Ph.D. Chairs, SSPPS Committee on Educational Policy (CEP)
Re: Request for Endorsement: Masters of Science Degree Program in Drug Development and Product Management
On behalf of the SSPPS CEP, we are requesting that the HSFC endorse the MS degree program in Drug Development and Product Management. At our February 24th meeting, the SSPPS CEP approved this proposal unanimously. The proposal is comprehensive and backed by market research to suggest that graduates would be well positioned for careers within the pharmaceutical industry. This program harnesses expertise from our SSPPS faculty and will provide a unique set of skills to a variety of learners. We enthusiastically support this proposal and look forward to its continued progress through the approval process and development as a degree program within the SSPPS, UCSD.
Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive, MC 0714 La Jolla, California 92093-0714 TEL: (858) 822-6629 FAX: (858) 822-6857
DATE: January 26, 2016
TO: Jan Hirsch, BS Pharm, PhD Associate Professor of Clinical Pharmacy
FROM: T. Mike Hsieh, M.D. Chair, Graduate Program Education Committee (GPEC)
SUBJECT: Proposal for a Program of Graduate Studies in Drug Development and Product Management for the Master of Science Degree
This letter is to endorse your proposal for a Master’s in Drug Development and Product Management. At the January 21, 2016 Graduate Program Education Committee meeting, the committee reviewed the full proposal. At the conclusion of the meeting, the committee unanimously approved the program as proposed by the Skaggs School of Pharmacy.
cc: James McKerrow, Dean – Skaggs School of Pharmacy and Pharmaceutical Sciences Williams Ettouati, Director – Industry Relations and Development
April 6, 2016
WILLIAMS ETTOUATI, PharmD Director, Industry Relations and Development Skaggs School of Pharmacy and Pharmaceutical Sciences MC 1177
Subject: Proposal for MS in Drug Development and Product Management
Dear Dr. Ettouati:
I am pleased to inform you that the Health Sciences Faculty Council (HSFC) has voted unanimously to endorse the proposal to pursue the development of a Master of Science degree in Drug Development and Product Management.
The HSFC thanks you for presenting at last night’s meeting. We wish you success as you continue your efforts in creating this program.
Sincerely,
Bob S. Carter, M.D., Ph.D. Chair, Health Sciences Faculty Council c: David A. Brenner, M.D., Vice Chancellor, Health Sciences James McKerrow, Dean, SSPPS Jan Hirsch, SSPPS Bruce Dunn, University Extension
HEALTH SCIENCES FACULTY COUNCIL 9500 Gilman Drive, MC 0602 San Diego, California 92093-0602 TEL: (858) 822-3855 FAX: (858) 534-1405 December 23, 2015
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Dr. Williams:
It is my pleasure to write a letter in support of the new Health Science Master of Science in Drug Development & Product Management proposal being submitted to UCSD review committees Program.
With the current proposed curriculum for the course, students should be in a solid position to better understand small molecule and biotherapeutic product development in the pharmaceutical R&D paradigm. Specifically, students will be exposed to critical concepts that go into the drug development process, namely Pharmacology/Toxicology activities, worldwide regulatory affairs activities and clinical development aspects, to name a few. The blend of the proposed course curriculum will better enable students pursuing a career in the pharmaceutical environment (large pharma and biotech). This level of education to professional students entering industry or transitioning to industry for the first time will better position students to quickly engage and contribute in the pharmaceutical work environment.
I fully support the efforts of the Skaggs School of Pharmacy and Pharmaceutical Sciences as they seek approval to support a program such as the MS in Drug Development & Product Management. The proposed MS program will greatly benefit students, the UCSD campus, and enhance the marketability of students entering the pharmaceutical or regulatory environment.
Sincerely,
R.J. Christopher, Ph.D., D.A.B.T., FCP Vice President, Preclinical Development
6124 Nancy Ridge Drive • San Diego, CA 92121 • 858.453.7200
December 17, 2015
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams:
It is my pleasure to write a letter of support for the proposed Health Science Master of Science in Drug Development & Product Management program being submitted to UCSD review committees.
I believe the program addresses a significant unmet need for professionals seeking a career in drug development and product management. In contrast to well-established educational pathways that can lead to research and discovery opportunities in the biotech and pharmaceutical industries, there is a dearth of similar programs and educational credentials for those interested in drug development and product management. Having worked in the biotech industry for over a decade, I can attest to the fact that all of my drug development experience have been obtained through “on-the-job” training, although I would have welcomed a more formal educational experience to solidify and expand my understanding of the process. In my current role as Chief Medical Officer of Pfenex and hiring manager for job openings in drug development and product management, I would welcome an expanded pool of applicants who are educated and certified by a highly-regarded institution such as UCSD.
I therefore fully support the efforts of the Skaggs School of Pharmacy and Pharmaceutical Sciences as it seeks approval for the Master of Science in Drug Development & Product Management program. I believe that this unique and well-designed program will provide students with a solid knowledge base and a practical skill set in the drug development and product management process. This program will help graduates transition into new jobs or assume greater responsibilities, not only in the pharmaceutical and biotech industries, but also with managed care organizations and regulatory agencies such as the Food and Drug Administration and the European Medicines Agency.
Please feel free to contact me if I can be of further assistance in the review process.
Sincerely,
Hubert C. Chen, M.D. Chief Medical Officer Pfenex Inc. 10790 Roselle St. San Diego, CA 92121 Telephone: (858) 352-4358 E-mail: [email protected]
2
UC San Diego Health Office of the Vice Chancellor Health Sciences 9500 Gilman Drive La Jolla, CA 92093‐0602 T: 858.534.1501 F: 858.822.0084
David A. Brenner, MD Vice Chancellor Health Sciences Dean, School of Medicine
February 4, 2016
Graduate Council MC 0002
Re: Masters Program in Drug Development As Vice Chancellor for Health Sciences at the University of California San Diego, I have met with the committee launching the new Master of Science Program in Drug Development and Product Management. I have discussed and reviewed their proposal, and I am pleased to endorse its launch at UCSD and supports its efforts. Sincerely,
David A. Brenner, MD Vice Chancellor for Health Sciences Dean, School of Medicine University of California San Diego Gary S. Firestein, M.D. Distinguished Professor of Medicine Dean and Assoc. Vice Chancellor, Translational Medicine Director, Clinical and Translational Research Institute Email: [email protected]
March 8, 2016
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive, MC 0714 La Jolla, CA 92093-0714
Dear Williams:
It is my pleasure to write a letter in support of the new Health Science Master of Science in Drug Development & Product Management proposal being submitted to UCSD review committees.
As you know from our previous meetings and discussions, the Clinical and Translational Research Institute (CTRI) is dedicated to train scientist, MDs and pharmacists in clinical development and translational research to improve patient care.
Your plan captures an area of career development that is truly underserved and that it will attract a broad range of students. For our part, the proposed MS program will help to insure that the high profile of the CTRI, and its strong interaction with the Skaggs School of Pharmacy and Pharmaceutical Sciences, remains nationally and globally visible.
With the current proposed curriculum for the course, students should be in a solid position to better understand small molecule and biotherapeutic product development in the pharmaceutical R&D paradigm. Specifically, students will be exposed to critical concepts that go into the drug development process, namely pharmacology and toxicology activities, worldwide regulatory affairs activities and clinical development aspects, to name a few.
The proposed course curriculum will better enable students pursuing a career in in the pharmaceutical and biotech industry as well as with managed care organizations and government agencies like the Food and Drug Administration, the European Medicine Agency and Academia. This level of education to professional students entering industry or transitioning to industry for the first time will better position students to quickly engage and contribute in the pharmaceutical work environment.
Accordingly I fully support approval of the MS in Drug Development & Product Management.
Sincerely,
Gary S. Firestein, M.D. UCSD HEALTH SCIENCES 9500 GILMAN DRIVE #0656, LA JOLLA, CA 92093-0656 TEL: (858) 534-2359 FAX: (858) 534-2606 Joan Heller Brown, PhD Distinguished Professor and Chair Department of Pharmacology [email protected] December 22, 2015
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams
It is my pleasure write a letter in support of the new Health Science Master of Science in Drug Development & Product Management proposal being submitted to UCSD review committees.
As you know from our previous meetings and discussions, the Department of Pharmacology had considered the possibility of developing our own Master of Science Program, based on what we perceived as a significant interest in training for jobs in the pharmaceutical industry. I believe your plan captures an area of career development that is truly underserved and that it will attract a broad range of students. For our part, the proposed MS program will help to insure that the high profile of the UCSD Department of Pharmacology, and its strong interaction with the Skaggs School of Pharmacy and Pharmaceutical Sciences, remains nationally and globally visible. In addition the program affords some of our faculty with further teaching opportunities in the more basic principles of pharmacology course that our emeritus faculty member Dr. Morton Printz will help design and direct. Accordingly I fully support the efforts of the Skaggs School of Pharmacy and Pharmaceutical Sciences as they seek approval to support a program such as the MS in Drug Development & Product Management.
I believe that this program is well designed to give students unique skills that can be applied in developing their knowledge and improve their careers. This program will help provide students get new jobs or be promoted in their companies, in the pharmaceutical and biotech industry as well as with managed care organizations and government agencies like academia, the Food and Drug Administration and the European Medicine Agency.
In summary I believe that this MS program will greatly benefit students, campus, and the community at large.
Sincerely,
Joan Heller Brown, PhD Distinguished Professor and Chair Department of Pharmacology
9500 GILMAN DRIVE, LA JOLLA, CALIFORNIA 92093-0636 Telephone (858) 822-5858 Fax (858) 822-0041 University of California San Diego 9500 Gilman Drive La Jolla, California 92093‐0736
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093‐0714
January 13, 2016
Dear Williams,
We are pleased to write in strongest support of your innovative and visionary proposal to establish a new Health Sciences Master of Science in Drug Development and Product Management.
UCSD is nearly unique among top‐flight universities in assembling, on a single campus, powerful research and training programs that span biomedicine, pharmaceutical sciences, clinical practice, chemistry, business management, and related disciplines. This unified structure creates opportunities to build interdisciplinary programs that are greater than the sums of their parts. Indeed, it is this setting which has led to development of the current campus‐wide drug discovery initiative, with leadership by the Center for Drug Discovery Innovation (CDDI).
Your proposal would likewise draw upon strengths across our campus, and beyond, to create a remarkable, integrated training program that could not be replicated by a student merely enrolling in a miscellany of existing classes. The program is well designed to provide students with key fundamentals, along with up to date information on emerging trends in drug development and product management, and, particularly through the project component, with currently relevant skills. It thus couples scholarly content with practicality, and we anticipate that it will attract particular interest from students aiming for personal and professional advancement in the pharmaceutical and biotech industries, managed care organizations, and government agencies like the Food and Drug Administration and the European Medicine Agency.
With its focus on drug development, your program also clearly helps to advance the goals of the CDDI, which include both research and education; and to enhance the visibility of UCSD as a center of activity in this field.
Please do not hesitate to call on us if we might be of help in advancing this important educational initiative.
Sincerely yours,
Michael K. Gilson, M.D., Ph.D. Thomas Hermann, Ph.D. Co‐Director, CDDI Co‐Director, CDDI Professor of Pharmacy and Pharmaceutical Sciences Associate Professor of Chemistry & Biochemistry Thursday, March 10, 16
Williams S. Ettouati, Pharm.D. Director, Industrial Relations & Development Health Sciences Associate Clinical Professor, N.S. University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences 9500 Gilman Drive #0714 La Jolla, CA 92093-0714
Dear Williams,
I am delighted to write a letter in support of the new Health Science Master of Science in Drug Development & Product Management proposal being submittted to UCSD review committees.
As you know from our previous meetings and discussions, the Moore Cancer Center (MCC)’s unique "bench-to-bedside" approach to cancer research and patient care supports the broadest range of cancer activities in the San Diego region. From research in molecular genetics to the most advanced treatments, MCC is dedicated to train MDs, Pharmacists and scientists in oncology clinical development, and cancer personalized medicine.
As the Senior Deputy Director for Clinical Science and Personalized Cancer Therapy, I believe your plan captures an area of career development that is truly underserveed, and that it will attract a broad range of students including MDs and Pharm.Ds. For our part, the proposed MS program will help to insure that the high profile of the MCC and its strong interaction with the Skaggs School of Pharmacy and Pharmaceutical Sciences remain nationally and globally visiblle.
Your proposal would likewise draw upon strengths across our campus, and the San Diego biotech and pharmaceutical cluster in San Diego. It would create a remarkable, integrated multidisciplinary team- approach training program that could not be replicated by a student merely enrolling in a miscellany of existing classes. The program is well designed to provide students with key fundamentals, along with up- to-date information on emerging trends in drug development and product management, and, particularly through the project component, with currently relevant skills. I would anticipate that it will attract particular interest from students aiming for personal and professional advancement in the pharmaceutical and biotech industries, managed care organizations, and government agencies like the Food and Drug Administration and the European Medicine Agency as well as academia.
This level of education to professional students entering industry or transitioning to industry for the first time will better position students to quickly engage and contribute in the pharmaceutical work environment.
Razelle Kurzrock, MD UC San Diego Moores Cancer Center 3855 Health Sciences Drive, #0658 • La Jolla, CA 92093 Phone (858) 246-1102 • Fax (858) 246-19115 • [email protected]
Accordingly I fully support the efforts of the Skaggs School of Pharmacy and Pharmaceutical Sciences as they seek approval to support a program such as the MS in Drug Development & Product Management.
In summary, I believe that this MS program will greatly benefit students, campus, and the community at large.
Sincerely,
Razelle Kurzrock, M.D. Murray Professor of Medicine Sr. Deputy Center Director, Clinical Science Director, Center for Personalized Cancer Therapy, Chief, Division of Hematology and Oncology
Razelle Kurzrock, MD UC San Diego Moores Cancer Center 3855 Health Sciences Drive, #0658 • La Jolla, CA 92093 Phone (858) 246-1102 • Fax (858) 246-19115 • [email protected] Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix G: Catalog Copy Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix G: Catalog Copy
The Master of Science in Drug Development and Product Management La Jolla Village Professional Center 8950 Villa La Jolla Dr., Suite A-212 (858) 246-5885 E-mail: [email protected] http://ddpm.ucsd.edu All courses, faculty listings, and curricular and degree requirements described herein are subject to change or deletion without notice. Updates may be found on the Academic Senate website: http://senate.ucsd.edu/catalog-copy/approved-updates/.
Program Description The Master of Science (MS) in Drug Development and Product Management has three aims: first, to give experienced professionals insight into the process of successful drug product development and deployment; second, to endow students with requisite knowledge and skill to collaborate effectively in the ongoing management of drug products; and third, to provide a solid, practical bridge to employment opportunities in pharmaceutical and managed care industries or related government agencies such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Distinctive features of the program include instruction by a combination of faculty who possess scholarly understanding and industry experience, a case and project-oriented approach to learning, options in professional focus, online course delivery, exposure to student colleagues with varied professional backgrounds, and connections with employers through online networking opportunities.
The MS in Drug Development and Product Management is a full-time, self-supporting degree program with a required course schedule that takes three academic quarters to complete online. The UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences is responsible for the academic management of the curriculum. UC San Diego Extension administers the program and provides student advising and career counseling services.
Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Admission New students are admitted in the fall each academic year. Prospective candidates should submit and complete the official UC San Diego online graduate application for admission (which includes a detailed statement of personal intent regarding the program), the application fee, one set of official transcripts from each institution attended after high school, three letters of professional recommendation, and a current résumé or curriculum vitae. At the discretion of the admissions committee, a personal interview may be required. The GRE/GMAT is not required; candidates should have an undergraduate degree and a minimum of 2 to 3 years of full-time work experience at the professional level. International applicants must submit official scores from the Test of English as a Foreign Language (TOEFL). The application deadline is May 20, 2020.
Program of Study The degree program is designed to be completed in three quarters of full time study. Classes are completely online to accommodate student employment and business travel. Students are required to complete thirty-six units of course work for the degree. Successful completion of a Masters Examination is also required.
Required Courses DDPM-200R - Opportunities in Pharma, Biotech and Managed Care (1 unit) DDPM 201R Pharmacotherapy and Diseases (3 units) DDPM-202R - Pharmaceutics for Small Molecules and Macromolecules (4 units) DDPM-203R - Pre-Clinical and Clinical Regulatory Submissions and Strategy (4 units) DDPM-204R - Clinical Trial Development from Phase 0 to Phase 3 Studies (4 units) DDPM-208R - Principles of Marketing Strategy, Product Value, and Life Cycle Management (4 units) DDPM-210R - Biologics and Biosimilars Drug Development (4 units) DDPM-211R - Managed Markets - Post Marketing Drug Utilization Management (4 units) DDPM-213R - Health Outcomes Evidence (4 units) DDPM-214R - Business Development & Entrepreneurship, Corporate & Intellectual Property Strategy (4 units) Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix H: Suggested UC and External Reviewers
Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix H: Suggested UC and External Reviewers
UC Reviewers:
Jan D. Hirsch, BS Pharm, PhD, FNAP Director and Founding Dean Pharmaceutical Sciences Susan & Henry Samueli College of Health Sciences 101 Theory, Suite 100 University of California, Irvine 92612 Email: [email protected]
Conan MacDougall, PharmD, MAS, BCPS, BCIDP Professor of Clinical Pharmacy Divine Family Endowed Chair in Clinical Pharmacy University of California San Francisco School of Pharmacy 533 Parnassus Ave, U-585 Box 0622 San Francisco, CA 94143-0622 415-502-9573 [email protected]
Outside reviewers:
Academic Jeff Lee, Pharm.D., FCCP Associate Professor, Pharmacy Practice Lipscomb University College of Pharmacy Email: [email protected] Phone: (615) 966-7012 office; (615) 232-4828 cell
C. E. (Gene) Reeder, PhD, RPh Director of Outcomes Research Distinguished Professor Emeritus Kennedy Pharmacy Innovation Center College of Pharmacy University of Southern Carolina Email: [email protected] Phone: 803-777-4395
Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Anne M. Libby, PhD Professor and Vice Chair for Academic Affairs University of Colorado Anschutz Medical Campus Email: [email protected] Phone: 303-724-9630
Industry:
Kourosh Parivar, M.Pharm. Vice President Head, Clinical Pharmacology Pfizer Oncology Pfizer Inc, La Jolla Phone: +1 858 638-6235 E-Mail: [email protected]
Andreas Koester MD, PhD Global Head, Janssen Clinical Innovation JANSSEN Pharmaceutical Companies of J&J San Diego, CA 92121 cell +1 858 224 2205 E-Mail: [email protected]
Joe Panetta CEO BIOCOM Phone: 858.455.0300 E-Mail: [email protected]
Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix I: MS in DDPM Student Program Evaluation
Program Evaluation for Masters in Drug Development and Product Management Help and Support for my learning STRONGLY STRONGLY DISAGREE NEUTRAL AGREE MARK ONE RESPONSE DISAGREE AGREE 1. Adequate academic counselling was available for me throughout the program 2. The course chairs in the program provided helpful feedback on my work 3. The course chairs in the program had thorough knowledge of the content of the course they taught 4. The course chairs in the program were enthusiastic about the program 5. The course chairs in the program cared about the progress of their students 6. The course chairs in the program are not biased among students
Resources to Support my learning STRONGLY STRONGLY DISAGREE NEUTRAL AGREE MARK ONE RESPONSE DISAGREE AGREE
7. Study materials in courses were up to date and useful 8. Online resources were sufficient for my educational needs 9. The online facilities used in the program were
sufficient for my education needs
Evaluation of my learning STRONGLY STRONGLY DISAGREE NEUTRAL AGREE MARK ONE RESPONSE DISAGREE AGREE
10. What I learned in this program will be valuable for me future. This program increased my knowledge in drug 11. development This program increased my knowledge in product 12. management This program improved my ability to work effectively 13. as a team This program developed my ability to investigate 14. and solve new problems 15. This program provided adequate networking opportunities between students, course chairs, and guest speakers Overall I was satisfied with the quality of my learning 16. experiences in this program My employer provided financial assistance for this 17. Yes No program (Circle Yes or No) 18. What did you like most about the program?
19. What did you dislike most about the program?
20. What suggestions do you have for improvements?
Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix J: Historical Student Data
Appendix J MS in DDPM self-reported Student Data as of May 1, 2020
Class of 2019 - 2020 2019 Admissions Statistics: Number of applications submitted: 61 Number of applications accepted: 28 Acceptance rate: 46% Total admitted (enrolled): 25 Completion rate: TBA (June 2020)
2019 -2020 Cohort Statistics: Total cohort: 25 Male: 7 (28%) Female: 18 (72%) International: 11 (44%) Domestic: 14 (56%) Under-Represented Minorities: 5 (20%)
Ethnicity (applicants may have indicated more than one): White/Caucasian: 2 African American/Black: 3 Latinx/Chicanx, or Spanish Origin: 5 Middle Eastern/Middle Eastern American: 1 Asian/Asian American: 7 (1 Korean, 3 Vietnamese, 4 Chinese, 2 Indian, 1 Pakistani) Chose not to disclose 11
Class of 2018 – 2019 2018 Admissions Statistics: Number of applications submitted: 54 Number of applications accepted: 20 Acceptance rate: 37% Total admitted (enrolled): 18 Completion rate: 100%
2018-2019 Cohort Statistics: Total cohort: 18 Male: 12 (67%) Female: 6 (33%) International: 4 (22%) Under-Represented Minorities: 1 (6%)
Ethnicity (applicants may have indicated more than one): White/Caucasian: 7 African American/Black: 0 Latinx/Chicanx, or Spanish Origin: 1 Middle Eastern/Middle Eastern American: 2 Asian/Asian American: 7 (1 Korean, 3 Vietnamese, 1 Chinese, 1 Indian, 1 Pakistani) Did not disclose: 1
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Appendix J MS in DDPM self-reported Student Data as of May 1, 2020
Diversity According to the most recent data available from the U.S. Bureau of Labor Statistics (https://www.bls.gov/cps/cpsaat18.htm), 7% of the pharmaceutical and medicine manufacturing workforce is comprised of individuals identifying their race as Black or African American and 16% identifying their ethnicity as Hispanic or Latinx. Women represent 39.4% of this workforce according to the 2019 report. The first DDPM cohort was comprised of 67% women, while the second cohort comprises 72% women (see Feb 6 Memo response for statistical breakdown by year). Six percent of the first student cohort self-reported as URM, while the current student cohort self-reported at 20% URM. We are pleased that the representation of women in the program is well above industry percentages, and that the URM from year one to year two more than doubled.
MS in DDPM Assessment To date, we have demonstrated the success of our program with a 100% graduation rate of our first cohort. In addition, two-thirds of them received promotions within their companies or found new career opportunities in their field of interest. Please see the table in question 10. 1. Domestic students outside of CA report challenges to applying. a. Maintaining a live in-person program will limit our ability to sustain our program given the finite and limited availability of talent in the San Diego region. Total applications in the 2018-2019 admissions cycle show a breakdown of 48/107, or 44.9%, domestic applicants, and 59/107, or 55.1%, international applicants. This is compared to total applications in the following admissions cycle of 2019 – 2020, showing a breakdown of 50/155, or 32.3%, domestic applicants, and 105/155, or 67.7%, international applicants. b. Based on conversations with prospective students, we have concluded that the percentage of domestic applications has decreased because applicants outside of San Diego and Southern California are unable to relocate to complete the in-person degree program. We have also attracted many out-of-country applicants with current work experience. Yet, relocation remains a barrier for many working professionals as many cannot afford to relocate, quit their jobs, or leave home for personal reasons. Prospective candidates are looking for an online solution that allows them to continue gaining real-world experience in their jobs while acquiring new skills and expanding their professional network in a graduate program.
2. The program is enriched by students who are able to continue working and use their real-world experience in the classroom. a. A large part of the curriculum focuses on practical application of drug development concepts using case studies. When students are working in industry while taking classes, all students benefit from the variety of perspectives in the classroom and are able to learn from each other. The talent in San Diego is limited, so to ensure that we can continue to have working students in our program, we need the ability to expand our outreach to qualified candidates outside the San Diego and Southern California region. b. The degree is quite rigorous, so although the first two cohorts have done well, an online program in which students would not have to travel or relocate would allow for students with tight schedules to better balance the demands of work, the degree, and life. With the greater flexibility innate in an online program, more students will feel that obtaining the degree is feasible and will be encouraged to apply. c. This program is designed to help students accelerate in their careers and, in many cases, help students make vertical transitions to positions of leadership at their current place of employment. Leaving a job in order to pursue a degree can make advancement more
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Appendix J MS in DDPM self-reported Student Data as of May 1, 2020
challenging. Students may miss opportunities at their places of work or at another company. However, working applicants have the security of being employed, allowing them to continue developing their careers while also gaining new skills and knowledge in the program, opening themselves up for immediate career advancement.
We used several metrics when assessing program success.
1. Graduation rates. All students (100%) from the 2018 – 2019 cohort passed all of their courses and graduated on time. 2. Student career advancement. a. The Career Advisor for the MS in DDPM tracks alumni employment data to ascertain the percentage of former students who have either received a promotion, obtained a new position, or advanced in an academic setting. b. Two thirds of the first class of the program have advanced their careers in the eight months following graduation. 3. Student Course Surveys (reviewed quarterly by MS in DDPM faculty)
Since graduating in June 2019, jobs and promotions were secured by the graduates following earning the MS in DDPM degree. See Table 1 Tracking Alumni Employment that follows. Male/Female statistics based on self-reported information in the graduate application.
18 Alumni – 12 females, 6 males: New Jobs Secured: 6:18 New Jobs Secured by Females: 3:6
Promotions Secured: 5:18 Promotions Secured by Females: 3:5
Advancement to PhD: 1:18 Advancement to PhD Secured by Females: 1:18
Total Career Advancements: 12:18
Notable Student Employers Biocom Illumina Astrazeneca Bristol-Myers Squibb Merck
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Appendix J MS in DDPM self-reported Student Data as of May 1, 2020
TABLE 1: Tracking Alumni Employment
DDPM 2019 Alumni KEY: Promotion New Job - Title Change Updated 4/29/20 Further Academic Study Employer at End of Program Former Title Current Employer Current Title Clinical Research 1 AstraZeneca Associate Astrazeneca Clinical Study Associate Manager Analytical Method Analytical Method Development 2 Abzena Dev. Associate Abzena Scientist - title change while enrolled Senior Medical 3 Novartis (former) Science Liason Zydus Cadila 4 Healthcare Limited Regulatory Affairs Zydus Regulatory Officer La Jolla Pharmaceutical Associate Director of 5 Company Process Dev. Unemployed Biocom Life Science Association of Director of Business 6 California Development Biocom Senior Director of Business Dev GlaxoSmithKline Digital Marketing Exelint Quality Assurance/Regulatory Affairs 7 (former) Assistant International Associate Roche Tissue 8 Diagnostics Project Coordinator Guardant Health Strategic Project Manager Bristol-Myers Catalent Drug Delivery Squibb Pharmaceutical Technology & Dev. (Purchased by 9 Solutions Consultant Catalent 2020) Research Consultant Senior Research PhD program in Translational Science at UT Health Science 10 aTyr Pharma Associate Center at San Antonio Senior Research Regulus 11 Regulus Therapeutics Associate Therapeutics Research Level 2 12 Illumina Associate Illumina Associate Scientist Emergent 13 Bioserv Corporation Project Coordinator BioSolutions Senior Project Coordinator General Scientist 2, Group 14 Atomics/Diazyme Supervisor Pursuing change from Biotech to Pharma Ionis 15 Ionis Pharmaceuticals Research Associate Pharmaceuticals Genomic Institute of 16 Novartis Research Scientific Associate II Merck Scientist II Ajinomoto Bio- Argonaut Manf. 17 Pharma Services Internal Auditor Services Inc. Project Manager
Samsung Biologics Senior Validation GTKS, Bethesda, Senior Validation Engineer - support 18 (former) Engineer MD tech transfer project management
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Proposal for a Master of Science Degree in Drug Development and Program Management (online)
Appendix K: Faculty Vitae
Brookie Best, PharmD
Hubert Chen, MD
Raphael Cuomo, PhD
Dilesh Doshi, PharmD
Williams Ettouati, PharmD
Cindy Evans Nguyen, JD
William Evans, JD
Caroline Forrester, PharmD
Katie Lyons, PharmD
Joseph Ma, PharmD
Jeremiah Momper, PharmD, PhD
Chantal Reed, PhD
Niels Vande Casteele, PharmD, PhD
Farrah Wong, PharmD
Felix K Yam, PharmD, MAS, BCPS, BCCP
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Brookie M. Best eRA COMMONS USER NAME (credential, e.g., agency login): msbest POSITION TITLE: Professor of Clinical Pharmacy and Pediatrics, Associate Dean of Pharmacy Education EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY
University of California, San Diego (UCSD) B.S. 06/1994 Chemistry/Chem. Education University of California, San Francisco (UCSF) Pharm.D. 06/1999 Pharmacy UCSD Health System Certificate 06/2000 PGY1 Pharmacy Resident UCSD Pediatrics Department, School of Medicine- Certificate 03/2004 Pediatric Pharmacology Fellow Rady Children’s Hospital San Diego NIH/CIHR 2nd Annual Summer Institute, Denver Certificate 07/2006 Maternal-Fetal Pharmacology University of California, San Diego M.A.S. 06/2007 Clinical Research
A. Personal Statement My broad research expertise is in clinical pharmacology studies in obstetric, pediatric and adult populations, with a focus on antiretrovirals and penetration of medications into compartments. I completed a clinical pharmacy residency and a postdoctoral NRSA-NIH Pediatric Clinical Pharmacology Research Fellowship, gaining the skills necessary to perform non-compartmental, compartmental and population pharmacokinetic analyses. In addition to modeling expertise, I have significant experience in clinical pharmacology trials in pregnant and breastfeeding women in the U.S. and worldwide. I was selected as a member of the Department of Health and Human Sciences Office of AIDS Research Perinatal Panel responsible for writing/revising the clinical guidelines statement for the clinical care of HIV-infected pregnant women in the U.S.
B. Positions and Honors Positions and Employment 2000-2010 Assistant Clinical Professor of Pharmacy, Non-salaried, UCSF, San Diego Program, CA 2003-2004 Lecturer, UCSD, Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA 2004-2010 Assistant Clinical Professor of Pharmacy and Pediatrics, UCSD, San Diego, CA 2010-2014 Associate Professor of Clinical Pharmacy and Pediatrics, UCSD, San Diego, CA 2012-2013 Interim Assistant Dean for Admissions and Outreach, UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences 2013-2016 Associate Dean for Admissions and Outreach, UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences 2014- Professor of Clinical Pharmacy and Pediatrics, UCSD, San Diego, CA 2016- Associate Dean for Pharmacy Education, UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences Selected Recent Professional Experience World Health Organization (WHO) 2018 Invited Participant, Paediatric ARV Drug Optimization (PADO) 4 Meeting, Advisory Group to the 2019 WHO Guideline Development Group (GDG) 2019- Invited Member, Paediatric ARV Working Group (PAWG), Standing Advisory Panel to the WHO 2019- Organizing Committee Member, WHO/IMPAACT Workshop on “Approaches to Optimize and Accelerate Pharmacokinetic Studies in Pregnant and Lactating Women”, 13-14 June 2019, Washington DC. U.S. Department of Health and Human Services (HHS) 2013- Member, Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission Guidelines, A Working Group of the Office of AIDS Research Advisory Council (OARAC) 2015 Member, Membership Subcommittee, Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission Guidelines, A Working Group of the Office of AIDS Research Advisory Council (OARAC) 2019- Invited Member, AACP and ACCP Representative, Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), Research and Training Working Group. PRGLAC is required by section 2041 of the 21st Century Cures Act, is governed by the Federal Advisory Committee Act, is advisory to the Secretary of HHS, and reports to the HHS Secretary and Congress.
National Institutes of Health 2014 Invited Reviewer, Westat/NICHD International and Domestic Pediatric and Maternal HIV Studies Network Clinical Site Recompetition 2014, 2015 Invited Reviewer, NRSA T32 Training Grants, Parent T32, Predoctoral Systems Developmental Biology, and Postdoctoral Obstetric and Pediatric Pharmacoepidemiology; PA-14-015, PAR-13- 019, PAR-13-112. 2015 Invited Reviewer, Special Emphasis Panel – 2015/05 Council ZHD1 DSR-A 50 1; RFA-HD-14- 013: Obstetric-Fetal Pharmacology Research Centers (OPRCs) 2015 Invited Reviewer, AIDS Clinical Studies and Epidemiology Study Section [ACE] Integrated Review Group, PA-12-040, PA-13-302, PA-13-304 (R01, R03, R21) 2018 Invited Reviewer/Study Participant, Program Evaluation of NIH Peer Review Processes: The Role of Anonymization (R01)
Selected Honors 2006 National Center for Leadership in Academic Medicine Scholar & Co-Valedictorian 2006 “40 Under Forty” Honoree, San Diego Metropolitan Uptown Examiner & Daily Business Report 2007 Role Model in Underserved Medicine, UCSD Student-Run Free Clinic Project 2010, 2013 Professor of the Year Award, Associated Students, UCSD SSPPS 2014 Distinguished Teaching Award, University of California, Academic Senate, San Diego Division
C. Contribution to Science
Perinatal and Breastfeeding Clinical Pharmacology Studies Pregnancy can significantly alter medication pharmacokinetics. Determining the correct dose of medication to use in pregnancy is critical both for viral suppression (prevention of HIV transmission and treatment of maternal disease) and for minimizing toxicity (adverse medication effects for the mother and the fetus). Our laboratory has played a vital role in determining the impact of pregnancy on the pharmacokinetics of numerous medications and developed treatment strategies to achieve therapeutic dosing during pregnancy. As a result of our work in this area, I was selected as a member of the Department of Health and Human Sciences Office of AIDS Research Perinatal Panel responsible for writing/revising the clinical guidelines statement for the clinical care of HIV-infected pregnant women in the U.S. Additionally, our lab is now exploring penetration of maternal medications and other substances into breastmilk, to assess and better characterize infant exposure and risk/benefit of breastfeeding in these circumstances. 1. Bertrand KA, Hanan NJ, Honerkamp-Smith G, Best BM, Chambers CD. Marijuana use by breastfeeding mothers: the concentration of cannabinoids in human milk samples. Pediatrics. 2018 Sep;142(3). Sep;142(3). 2. Best BM, Stek AM, Mirochnick M, Hu C, Li H, Burchett SK, Rossi SS, Smith E, Read JS, Capparelli EV, for the IMPAACT 1026 Study Team Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2010 Aug 1;54(4):381-8. PMID: 20632458. NIHMSID: NIHMS248675. 3. Stek A, Best BM, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, Cressey TR, Mofenson LM, Smith E, Shapiro D, Mirochnick M, IMPAACT P1026s Protocol Team. Pharmacokinetics of once versus twice daily darunavir in pregnant HIV-infected women. J Acquir Immune Defic Syndr. 2015 May 6. [Epub ahead of print]. PMID: 25950206. 4. Best BM, Burchett SK, Li H, Stek A, Hu C, Wang J, Hawkins E, Byroads M, Watts DH, Smith E, Fletcher CV, Capparelli EV, Mirochnick M, P1026s Team. Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med. 2015 May 11. doi: 10.1111/hiv.12252. [Epub ahead of print]. PMID: 25959631.
Pediatric Clinical Pharmacology of Agents to Treat Kawasaki Disease Kawasaki disease is the leading cause of acquired heart disease in children. Treatment with IVIG and aspirin prevents cardiovascular complications in most patients who are quickly diagnosed and treated; however, some patients are refractory to standard treatment or have cardiovascular morbidity at the time of diagnosis. No new treatments have been approved for this disease in three decades. Our Kawasaki Disease Research Center has investigated newer biologics and has re-purposed existing medications to improve outcomes in these patients. As the pediatric pharmacologist on the team, I provide input as to appropriate pharmacology endpoints and studies to determine the best doses of these medications to use in children (see citations in Personal Statement above along with the selected citations below). 1. Best B, Burns J, DeVincenzo J, Phelps S, Blumer J, Wilson J, Capparelli E, Connor J, Pediatric Pharmacology Research Unit Network. Pharmacokinetic and safety evaluation of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Curr Ther Res Clin Exp. 2003 Feb;64(2):96-115. 2. Tremoulet AH, Best BM, Song S, Wang S, Corinaldesi E, Eichenfeld J, Burns JC. Resistance to intravenous immunoglobulin in children with Kawasaki disease. J Pediatr 2008 Jul;153(1):117-21. EPub 2008 Mar 4. PubMed PMID 18571548. PubMed Central PMCID: PMC2526555. NIHMSID: NIHMS56323. 3. Burns JC, Best BM, Mejias A, Mahoney L, Fixler DE, Jafri HS, Melish ME, Jackson MA, Asmar BI, Lang DJ, Connor JD, Capparelli EV, Keen ML, Mamun K, Keenan GF, Ramilo O. Infliximab treatment of intravenous gamma globulin-resistant Kawasaki disease. J Pediatr. 2008 Dec;153(6):833-838. PubMed PMID: 18672254. PubMed Central PMCID: PMC2856847. NIHMSID: NIHMS80831. 4. Sato Y, Molkara D, Daniels L, Tremoulet A, Shimizu C, Kanegaye J, Best B, Snider J, Frazer J, Maisel A, Burns JC. Cardiovascular biomarkers in acute Kawasaki disease. Int J Cardiol. EPub 2011 Jul 19. PubMed PMID: 21777987.
Antiretroviral Cerebral Spinal Fluid (CSF) Penetration HIV is a neurotropic virus that establishes in the central nervous system early in infection. Highly active antiretroviral therapy has decreased the incidence of frank HIV related dementia; however, mild to moderate HIV-associated neurocognitive disorders (HAND) remain highly prevalent, leading to a reduction in the quality of life and increased morbidity and mortality. Our laboratory was the first to employ sparse sampling and semi- physiologic based pharmacokinetic modeling to characterize the discordance in plasma and CSF ART concentration vs. time profiles. This approach showed many ART have limited central nervous system (CNS) penetration into the CSF, below levels predicted by protein binding. These findings were used to develop and validate the CNS Penetration-Effectiveness ranking which has been linked with neurocognitive function. 1. Letendre SL, Marquie-Beck J, Capparelli E, Best B, Clifford DB, Collier A, Gelman BG, McArthur JC, McCutchan JA, Morgello S, Simpson D, Grant I, Ellis RJ, CHARTER Group. Validation of the CNS penetration-effectiveness (CPE) score for quantifying antiretroviral penetration into the central nervous system. Arch Neurol. 2008 Jan;65(1):65-70. PubMed PMID: 18195140. PubMed Central PMCID: PMC2763187. NIHMSID: NIHMS133361. 2. Nguyen A, Rossi S, Croteau D, Best BM, Clifford D, Collier AC, Gelman B, Marra C, McArthur J, McCutchan JA, Morgello S, Simpson D, Ellis RJ, Grant I, Capparelli E, Letendre S, for the CHARTER Group. Etravirine in cerebrospinal fluid is highly protein bound. J Antimicrob Chemother. 2013 May;68(5):1161-1168. Epub 2013 Jan 20. PubMed PMID: 23335197. PubMed Central PMCID: PMC3625433. 3. Best BM, Letendre SL, Brigid E, Clifford DB, Collier AC, Gelman BB, McArthur JC, McCutchan JA, Simpson DM, Ellis R, Capparelli EV, and Grant I for the CHARTER Group. Low atazanavir concentrations in cerebrospinal fluid. AIDS. 2009 Jan 2;23(1):83-87. PMID: 19050389. PubMed Central PMCID: PMC2642983. NIHMSID: NIHMS89942. 4. Croteau D, Best BM, Letendre S, Rossi SS, Ellis RJ, Clifford DB, Collier AC, Gelman BB, McArthur JC, McCutchan JA, Morgello S, Grant I, CHARTER Group. Lower than expected maraviroc concentrations in cerebrospinal fluid exceed the wild-type CCR5-tropic HIV-1 50% inhibitory concentration. AIDS. 2012 Apr 24;26(7):890-3. PMID: 22313954. PubMed Central PMCID: PMC3454507.
Pharmacy Education Research Effective education of our next generation of health-care providers is one of my passions. My first publication during my undergraduate training explored the use of multimedia presentations (a precursor to PowerPoint) in teaching college chemistry. As faculty at UCSD, I invest significant effort in both teaching pharmacokinetics and other topics in the classroom and encouraging and supporting students to engage in clinical research via mentoring and stipend support through my T35 training grant and other grant opportunities. 1. Whitnell RM, Fernandes EA, Almassizadeh F, Love JJC, Dugan BM, Sawrey BA, and Wilson KR. Multimedia chemistry lectures. J Chem Educ. 1994 Sep;71(9):721-725. Cover Article. 2. Morello CM, Singh RF, Chen KJ, Best BM. Enhancing an introductory pharmacy practice experience at free medical clinics. International Journal of Pharmacy Practice. 2010 Feb;18(1):51-57. PMID: 20405596. 3. Atayee RS, Singh RF, Best BM, Freedman BA, Morello CM. An active-learning assignment involving peer- to-peer presentations to improve pharmacy students' attitudes and knowledge of dietary supplements. Am J Pharm Educ. 2012 Aug 10;76(6):113. PMID: 22919089. 4. Morello CM, Neighbors M, Luu L, Kobayashi S, Mutrux B, Best BM. Description and effectiveness of an innovative first-year student pharmacist diabetes self-care education program on confidence, knowledge and clinical applicability. Am J Pharm Educ. 2013;77(10). Article 215. doi: 10.5688/ajpe7710215. PMID: 24371339.
Complete List of Published Work in My Bibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/brookie.best.1/bibliograpahy/48208114/public/?sort=date&dir ection=ascending
D. Research Support Ongoing Research Support 2T35 HD064385-06 Best (PI) 08/01/2017 – 06/30/2022 Predoctoral Research Training in Maternal and Pediatric Pharmacology To provide an integrated educational and practical mentored research training experience for predoctoral students in the Health Sciences. Role: PI
1 R01 MH107345-01A1 Heaton (PI) 09/24/2015 – 06/30/2020 Age-related Determinants of HAND: A 12 Year Follow-up of CHARTER Participants To build on prior cross-sectional findings comparing HIV+ and HIV- adults to determine if older HIV+ adults (≥ 60 years) have greater CNS decline over 12 years than younger HIV+ adults (< 60 years), while controlling for effects of "normal aging" on neurocognitive function. Role: Co-Investigator (Clinical Pharmacologist)
1U54 D071600-01 Tremoulet/Capparelli (MPI) 09/20/2016 – 06/30/2021 Pediatric Developmental Pharmacology for Inflammatory and Infectious Diseases To study translational and developmental pharmacology of antimicrobial therapies including antimicrobial peptides. Role: Co-investigator (Pediatric Pharmacologist)
California HIV/AIDS Research Program Morris (PI) 04/01/2016 – 06/30/2020 PrEP in Transpersons: CCTG 603, 604 To examine new strategies to improve treatment and prevention of HIV in transgender persons. Role: Co-investigator (Pharmacologist)
1 R01 HD096798-01 Wachman (PI) 10/01/2018 – 05/31/2023 Naltrexone PK in Pregnancy To determine the safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorder. Role: Co-Investigator (Perinatal Pharmacologist)
5 UM1 AI06716-02 Aldrovandi (PI) 01/01/2014 – 11/30/2020 Laboratory Center – IMPAACT Leadership Group To decrease HIV incident infection including mother-to-child transmission (MTCT) of HIV and to decrease mortality/morbidity associated with HIV infection, co-infections, and co-morbidities in pregnant/postpartum women, children (including infants), and adolescents worldwide. Role: Pharmacology Specialty Lab PI
5 UM1 AI068632-12 Nachman (PI) 12/01/2017 – 11/30/2020 International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group To perform drug assay on samples collected from the conduct of clinical research studies by the IMPAACT study site. Role: PI, IMPAACT Pharmacology Core Laboratory
UM1 AI068632-11 Nachman (PI) 12/01/2014 – 11/30/2020 NIH/Subaward from Johns Hopkins University: IMPAACT P1080 To determine psychiatric and antiretroviral medication concentrations in HIV-infected and uninfected children and adolescents. Role: Protocol Chair
2003444578 Nachman (PI) 12/14/2016 – 11/30/2020 NIH/Subaward from Johns Hopkins University: IMPAACT P1026s To describe pharmacokinetic properties of antiretrovirals and related drugs during pregnancy and postpartum. Role: Protocol Vice Chair
2003215535 Nachman (PI) 07/01/2016 – 12/31/2020 ViiV/Subaward from Johns Hopkins University: IMPAACT 2007 To establish safety and pharmacokinetics of maraviroc in HIV-1-exposed infants at risk of acquiring HIV-1 infection. Role: Protocol Vice Chair
2003215514 Nachman (PI) 07/01/2016 – 12/31/2020 ViiV/Subaward from Johns Hopkins University: IMPAACT 2007 LOC-IMPAACT Lab: To establish safety and pharmacokinetics of maraviroc in HIV-1-exposed infants at risk of acquiring HIV-1 infection. Role: Pharmacology coordinating lab
2003859060 Nachman (PI) 04/01/2018 – 12/31/2022 Merck Sharp & Dohme Corp./Subaward from Johns Hopkins University: IMPAACT 2014 To determine the pharmacokinetics and safety of doravirine alone and in a fixed dose combination tablet in adolescents. Role: Protocol Vice Chair
Completed Research Support (Last 3 years) 1R01 HD081296-01 Tremoulet (PI) 09/23/2014 – 06/30/2019 Phase I and IIA Trial of Atorvastatin in Children with Acute Kawasaki Disease To determine if the non-lipid lowering effects of atorvastatin show promise in reducing arterial wall inflammation in children with acute KD. Role: Co-investigator (Pediatric Pharmacologist)
Hubert C. Chen, M.D.
Phone: 858-353-7169 • Email: [email protected] Summary • Physician-scientist with ~15 years of research & development and corporate development experience in multiple therapeutic areas, plus 6 additional years of basic research, clinical care, and teaching experience in academia • ~10 years as an executive in start-up (publicly-traded and private) companies; proven ability to work in a fast-paced environment, both as a strategic leader and a “roll-up-the-sleeves” tactician • Skilled in negotiating with multiple regulatory agencies (US FDA, European Medicines Agency, Japan’s PMDA, Health Canada) • Passion for translating scientific breakthroughs into the clinic and proposing abbreviated development programs with regulatory agencies, with demonstrated creativity, initiative, and problem-solving skills • Board certified in Internal Medicine and Endocrinology, Diabetes & Metabolism
Professional Experience 09/2018-Present Metacrine Inc. San Diego, CA Chief Medical Officer Corporate officer responsible for leading Metacrine’s pipeline products through clinical development towards registration and commercialization. • Phase 1 single-dose and multiple-dose first-in-human study in the Netherlands, drug-drug interaction study, and Phase 2 proof-of-concept studies in nonalcoholic steatohepatitis (NASH), irritable bowel syndrome – diarrhea (IBS-D) secondary to excess bile acids, and ulcerative colitis (UC) with MET409, an optimized, best-in-class farnesoid X receptor (FXR) agonist 11/2014−Present Pfenex Inc. San Diego, CA Medical & Scientific Advisor (09/2018-Present) Chief Medical & Scientific Officer (03/2017−09/2018) Chief Medical Officer (11/2014−02/2017) Senior advisor and ex-corporate officer responsible for the research and development and portfolio prioritization of complex protein therapeutics, including biosimilars, therapeutic equivalent peptides and novel vaccines. • Phase 1 bioequivalence study, Phase 3 multi-center osteoporosis study, formative and summative human factors studies, comparative nonclinical pharmacology and toxicology studies, and multiple meetings with FDA, EMA, and Japan PMDA for Bonsity (PF708), a therapeutic equivalent/biosimilar to Forteo for the treatment of osteoporosis • Phase 2 study in New Zealand, global Phase 3 study design, and multiple meetings with FDA, EMA, and Health Canada for PF582, a biosimilar to Lucentis for the treatment of neovascular retinal diseases • Phase 1 study in Australia, global Phase 3 study design, and multiple meetings with FDA for PF530, a biosimilar to Betaseron for the treatment of multiple sclerosis • Successful negotiation with FDA on an abbreviated clinical program for PF529, a biosimilar to Neulasta for the treatment of chemotherapy-induced febrile neutropenia • IND submission, Phase 1 first-in-human study, end-of-Phase 1 FDA meeting, and Principal Investigator for Biomedical Advanced Research and Development Authority (BARDA)-funded Px563L and RPA563, two formulations of a novel anthrax vaccine • Identification and prioritization of new product opportunities, including Bonsity line extension and biobetters in orphan indications • Line manager of Analytical/Bioanalytical Sciences, Clinical Operations, Delivery Devices, Molecular Biology, Pharmacology/Toxicology, Upstream/Downstream Processing, consisting of ~35 full-time employees and part-time contractors/consultants 08/2015−08/2017 Dauntless Therapeutics San Diego, CA Medical Advisor Provided medical and regulatory guidance in the development of DP1038, an intranasal formulation of octreotide for the treatment of neuroendocrine tumors; helped the company establish definitive clinical proof-of-concept with the asset. • Pre-IND meeting and IND submission • An integrated Phase 1 PK/PD study, consisting of a 4x4 modified Latin square design and a 2x2 crossover design in healthy subjects
07/2012−10/2014 Aileron Therapeutics Cambridge, MA Vice President, Clinical Development Corporate officer responsible for the development and commercialization strategy of Stapled Peptides. • First IND submission and Orphan Drug Designation application for the Stapled Peptide platform • An integrated single-dose/multiple-dose Phase 1 study for ALRN-5281, a long-acting growth hormone releasing hormone (GHRH) agonist for the treatment of adult GH deficiency and aging- related frailty • IND submission and design of Phase 1/2 study for ALRN-6924, a first-in-class MDM2/MDMX dual inhibitor for cancers expressing wild-type p53 tumor suppressor protein
09/2009−06/2012 Regulus Therapeutics San Diego, CA Vice President, Translational Medicine Corporate officer responsible for the preclinical & clinical development of microRNA-based medicines. • Research and early development strategy through clinical proof-of-concept in multiple therapeutic areas: atherosclerosis, diabetes, fibrosis, hepatitis C infection, and immunology • Clinical candidate nomination criteria and design of IND-enabling toxicology studies for a novel technology platform • Chair of 3 joint steering committees (hepatitis C, fibrosis, immunology) with international pharmaceutical partners • Line manager of Metabolism and Delivery Research departments, consisting of 6 directors, scientists, and research associates
09/2006−08/2009 Amylin Pharmaceuticals San Diego, CA Senior Director, Clinical Research & Corporate Development (09/2007-08/2009) Director, Clinical Research (09/2006-09/2007)
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Program leader responsible for the development of obesity and type 2 diabetes programs, and senior management member responsible for the prioritization of pipeline assets and research opportunities. • 3 IND-enabling preclinical development programs & INDa submission • Phase 1 first-in-human and multiple-dose crossover studies in obese subjects • Phase 2 multi-center, proof-of-concept and dose-ranging studies in obese subjects • Phase 3 development strategy for pramlintide/metreleptin in obesity • Oversight of clinical candidate nomination process for diabetes & obesity programs
03/2004−09/2006 Amgen, Inc. Thousand Oaks, CA Associate Director, Medical Sciences Early development leader responsible for the design and execution of preclinical and early clinical strategy in type 2 diabetes, obesity, osteoporosis, and muscle atrophy/cachexia programs. • Phase 0 biomarker study in immobilized healthy subjects • Phase 1 first-in-human studies in healthy subjects • Phase 1/2 multiple-dose studies in immobilized subjects, type 2 diabetes, and prostate cancer • Phase 4 observational study in postmenopausal women with osteoporosis
Academic Appointments & Education
07/2002−06/2012 University of California, San Francisco San Francisco, CA
Assistant Clinical Professor of Medicine, Clinical Instructor of Medicine 09/2001−03/2004 Gladstone Institute of Cardiovascular Disease San Francisco, CA Staff Research Investigator, Staff Scientist, Research Scientist 07/1998−06/2002 University of California, San Francisco San Francisco, CA Clinical fellowship in diabetes, endocrinology & metabolism 07/1998−08/2001 Gladstone Institute of Cardiovascular Disease San Francisco, CA Basic research fellowship in lipid metabolism and energy homeostasis 06/1995−06/1998 Massachusetts General Hospital Boston, MA Internship and residency in internal medicine 08/1991−05/1995 Columbia University New York, NY M.D. 09/1987−06/1991 Stanford University Stanford, CA B.A.S. in political science and biological sciences
Publications – Research Articles
1. Chen HC, Rao M, Sajan MP, Standaert M, Kanoh Y, Miura A, Farese RV Jr., Farese RV. The role of adipocyte-derived factors in enhancing insulin signaling in skeletal muscle and white adipose tissue of mice lacking acyl coenzyme A:diacylglycerol acyltransferase 1, Diabetes 2004, 53:1445– 1451 2. Standaert ML, Sajan MP, Miura A, Kanoh Y, Chen HC, Farese RV Jr., Farese RV. Insulin-induced activation of atypical protein kinase C, but not protein kinase B, is maintained in diabetic (ob/ob and
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Goto-Kakazaki) liver. Contrasting insulin signaling patterns in liver versus muscle define phenotypes of type 2 diabetic and high-fat-induced insulin-resistant states. J. Biol. Chem. 2004, 279:24929–24934 3. Chen HC, Jensen DR, Myers HM, Eckel RH, Farese RV Jr. Obesity resistance and enhanced glucose metabolism in mice transplanted with white adipose tissue lacking acyl CoA:diacylglycerol acyltransferase 1. J. Clin. Invest. 2003, 111:1715–1722 4. Chen HC, Ladha Z, Smith SJ, Farese RV Jr. Analysis of energy expenditure at different ambient temperatures in mice lacking DGAT1. Am. J. Physiol. Endocrinol. Metab. 2003, 284:E213–E218 5. Chen HC, Stone SJ, Zhou P, Buhman KK, Farese RV Jr. Dissociation of obesity and impaired glucose disposal in mice overexpressing acyl coenzyme A:diacylglycerol acyltransferase 1 in white adipose tissue. Diabetes 2002, 51:3189–3195 6. Chen HC, Ladha Z, Farese RV Jr. Acyl coenzyme A:diacylglycerol acyltransferase 1 deficiency increases leptin sensitivity in murine obesity models. Endocrinology 2002, 143:2893–2898 7. Chen HC, Bandyopadhyay G, Sajan MP, Kanoh Y, Standaert M, Farese RV Jr., Farese RV. Activation of the ERK pathway and atypical protein kinase C isoforms in exercise- and aminoimidazole-4-carboxamide-1-β-D-riboside (AICAR)-stimulated glucose transport. J. Biol. Chem. 2002, 277:23554–23562 8. Chen HC, Farese RV Jr. Determination of adipocyte size by computer image analysis. J. Lipid Res. 2002, 43:986–989 9. Chen HC, Smith SJ, Ladha Z, Jensen DR, Ferreira LD, Pulawa LK, McGuire JG, Eckel RH, Pitas RE, Farese RV Jr. Increased insulin and leptin sensitivity in mice lacking acyl CoA:diacylglycerol acyltransferase 1. J. Clin. Invest. 2002, 109:1049–1055 10. Chen HC, Smith SJ, Tow B, Elias PM, Farese RV Jr. Leptin modulates the effects of acyl:CoA diacylglycerol acyltransferase deficiency on murine fur and sebaceous glands. J. Clin. Invest. 2002, 109:175–181 11. Chen HC. Intravenous calcium replacement in asymptomatic hypocalcemia of critical illness. Endocrinologist 2001, 11:364–367 12. Smith SJ, Cases S, Jensen DR, Chen HC, Sande E, Tow B, Sanan DA, Raber J, Eckel RH, Farese RV Jr. Obesity resistance and multiple mechanisms for triglyceride synthesis in mice lacking Dgat. Nat. Genet. 2000, 25:87–90 13. Chen HC, Masharani U. Hashimoto’s encephalopathy. Southern Med. J. 2000, 93:504–506
Publications – Invited Reviews 1. Schneider C, Chen HC. An efficacious anthrax vaccine based on a recombinant protein. Intl. Biopharm. Industry 2018, 1(3):14-17 2. Chen HC, Roth JD, Schroeder BE, Weyer C. Role of islet-, gut-, and adipocyte-derived hormones in the central control of food intake and body weight: Implications for an integrated neurohormonal approach to obesity pharmacotherapy. Curr. Diabetes Rev. 2008, 4:79-91
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3. Chen HC. Enhancing energy and glucose metabolism by disrupting triglyceride synthesis: Lessons from mice lacking DGAT1. Nutr Metab (Lond) 2006, 3:10 4. Chen HC, Farese RV Jr. Inhibition of triglyceride synthesis as a treatment strategy for obesity: Lessons from DGAT1-deficient mice. Arterioscler. Thromb. Vasc. Biol. 2005, 25:482–486 5. Chen HC, Farese RV Jr. Fatty acids, triglycerides, and glucose metabolism: Recent insights from knockout mice. Curr. Opin. Clin. Nutr. Metab. Care 2002, 5:359–363 6. Buhman KK, Chen HC, Farese RV Jr. The enzymes of neutral lipid synthesis. J. Biol. Chem. 2001, 276:40369–40372 7. Chen HC, Farese RV Jr. Turning WAT into BAT gets rid of fat. Nat. Med. 2001, 7:1102–1103 8. Chen HC. Molecular mechanisms of sterol absorption. J. Nutr. 2001, 131:2603–2605 9. Chen HC, Farese RV Jr. DGAT and triglyceride synthesis: A new target for obesity treatment? Trends Cardiovasc. Med. 2000, 10:188–192 10. Chen HC, Farese RV Jr. Steroid hormones: Interactions with membrane-bound receptors. Curr. Biol. 1999, 9:R478–R481
Select Abstracts – Oral Presentation
1. Chen HC, Cremer K, Bischoff E, Lee K-J, Littler R, van de Wetering J, Arold G, Duong M-N, Song K. MET409, an optimized sustained FXR agonist, was safe and well-tolerated in a 14-day phase 1 study in healthy subjects. NASH-TAG Conference, Park City, UT, 2019 2. Nicandro JP, Chen K, Deng W, Ellero C, Kesty N, Flanagan S, Shen L, Chen HC. Use of the Continuous Reassessment Method in the first human study of the amylin mimetic AC2307. 110th annual meeting of the American Society for Clinical Pharmacology and Therapeutics, Washington, DC, 2009 3. Chen HC, Farese RV Jr. Increased leptin resistance in mice overexpressing DGAT1 in white adipose tissue. 63rd annual meeting of the American Diabetes Association, New Orleans, LA, 2003 4. Chen HC, Smith SJ, Tow B, Elias PM, Farese RV Jr. Leptin modulates the effects of DGAT deficiency on fur and sebaceous glands in mice. 31st annual meeting of the European Society of Dermatological Research, Stockholm, Sweden, 2001 5. Chen HC, Jensen DR, Ferreira L, Pulawa L, Standaert ML, Kanoh Y, Sajan MP, Eckel RH, Farese RV, Farese RV Jr. Increased insulin sensitivity in DGAT-deficient mice. 83rd annual meeting of the Endocrine Society, Denver, CO, 2001 6. Chen HC, Smith SJ, Ladha Z, Farese RV Jr. Increased leptin sensitivity in DGAT-deficient mice. Keystone Symposium, Taos, NM, 2001 7. Chen HC, Smith SJ, Farese RV Jr. Obesity resistance in Dgat-deficient mice is leptin-dependent. 82nd annual meeting of the Endocrine Society, Toronto, Canada, 2000
Invited Presentations
• World Biosimilar Congress USA, San Diego, CA 2019 • World Biosimilar Congress, San Diego, CA 2018 • Bio Innovation Leaders Summit, Berlin, Germany 2018 • World Biosimilar Congress, San Diego, CA 2017 • DIA Biosimilars Conference, Washington, DC 2016 • GPhA Biosimilars Council Conference, Bethesda, MD, 2016
5 • Ophthalmology Innovation Summit at the Annual Meeting of the American Society of Retinal Specialists, San Francisco, CA 2016 • JMP Securities Life Sciences Conference, New York, NY 2016 • Biosimilars & Biobetters 4th Annual Congress, London, United Kingdom 2016 • UCLA Anderson School of Management Annual Healthcare Conference, Los Angeles, CA 2016 • The American College of Clinical Pharmacy Fundamentals Webinar: Clinical Trials and Drug Development, 2015 • BIO CEO & Investor Conference, New York, NY 2015 • Oppenheimer Annual Healthcare Conference, New York, NY 2013 • AsiaTIDES Conference, Tokyo, Japan, 2013 • FierceBiotech Webinar: Mastering Translational Medicine in Clinical Trials, 2012 • UCSD Endocrine Grand Rounds, San Diego, CA, 2012 • Society of Toxicology (Southern California) Annual Meeting & Symposium, Irvine, CA, 2011 • HCV Drug Discovery Conference, San Diego, CA, 2011 • UCSD School of Pharmacy and Pharmaceutical Sciences Drug Discovery & Development Course, University of California, San Diego, CA, 2010-2012 • Canaccord Adams Hepatitis C Conference, New York, NY, 2010 • Obesity and Diabetes Drug Development Summit, Arlington, VA, 2009 • California State University 21st Annual Biotechnology Symposium, Los Angeles, CA, 2009 • Obesity Drug Development Conference, London, United Kingdom, 2008 • St Luke’s-Roosevelt Hospital Endocrine Grand Rounds, Columbia University College of Physicians and Surgeons, New York, NY, 2008 • Cleveland Clinic Obesity Summit, Cleveland, OH, 2008 • Obesity Drug Development Summit, Arlington, VA, 2008 • Obesity Drug Development World Congress, London, United Kingdom, 2007 • American Association of Clinical Endocrinologists-Shiraz University Association Scientific Symposium, Manhattan Beach, CA, 2007 • Obesity Drug Development Summit, Arlington, VA, 2007 • American Association of Clinical Endocrinologists (California Chapter) Annual Meeting & Symposium, San Francisco, CA, 2006 • Nutrition and Metabolism Society Conference on Nutritional and Metabolic Aspects of Carbohydrate Restriction, Brooklyn, NY, 2006 • Obesity Drug Development Summit, Arlington, VA, 2005 • Wageningen Centre for Food Sciences Annual Summit, Wageningen, the Netherlands, 2004 • North American Association for the Study of Obesity Annual Meeting, Las Vegas, NV, 2004 • The Endocrine Society Annual Meeting, New Orleans, LA, 2004 • Stanford University School of Medicine Endocrine Grand Rounds, Stanford, CA, 2004 • UCSD Endocrine Seminar, San Diego, CA, 2003 • University of Pennsylvania Diabetes Center Seminar, Philadelphia, PA, 2003 • UCSF Department of Laboratory Medicine Grand Rounds, San Francisco, CA, 2003 • Washington University School of Medicine Endocrine Seminar, St. Louis, MO, 2003 • Baylor College of Medicine Endocrine Seminar, Houston, TX, 2003 • International Symposium on Triglycerides, Metabolic Disorders, and Cardiovascular Disease, New York, NY, 2003 • Western Pharmacology Society Annual Meeting, Reno, NV, 2003 • UCSF Endocrine Grand Rounds, San Francisco, CA, 2002 • American Diabetes Association Scientific Sessions, Philadelphia, PA, 2001 • Adiposcience Meeting, Osaka, Japan, 2000
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Research Grants
• National Institutes of Health career development award (K08-DK61363), 2002–2004 (funding for 2005–2007 was declined) • Parke-Davis CardioFellows Foundation postdoctoral fellowship, 2001–2002 • Endocrine Fellows Foundation research grant, 1999–2000 Honors, Awards, and Board Membership
• Scientific Advisory Board, Boulder Peptide Symposium, 2015 • Scientific Advisory Board, Keystone Symposia, 2012 • Fellow, North American Association for the Study of Obesity, 2005 • Keystone Symposia Scholarship, 2001 & 2002 • American Diabetes Association 15th Northern California Research Symposium research award, 2000 • Endocrine Society’s Burrough-Wellcome Fund and Molecular and Cellular Research awards, 2000 • Alpha Omega Alpha Honor Medical Society, 1995 • The Cum Laude Society, 1987
Medical Certification & Licensure
• Diplomate in Internal Medicine, American Board of Internal Medicine; initial certification 1998–2008, recertification 2011–2021 • Diplomate in Endocrinology, Diabetes & Metabolism, American Board of Internal Medicine; initial certification 2002–2012, recertification 2012–2022 • California Medical License #AFE65203: active since May 1998
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CURRICULUM VITAE Raphael E. Cuomo, PhD, MPH, CPH, FRSPH
EDUCATION 2013-2017 Ph.D. in Public Health University of California, San Diego and San Diego State University (Joint Program) 2013-2014 Professional Certificate in Sustainability Harvard University 2011-2013 M.P.H. in Health Management and Policy San Diego State University 2007-2011 B.S. in Biology (Minor in Art) Lafayette College
ADDITIONAL TRAINING 2017-2018 Post-Doctoral Scholarship University of California, San Diego School of Medicine 2014 -2016 Pre -Doctoral Fellowship University of California, San Diego School of Medicine
2014 -2015 Scholarship University of California, San Diego Moores Cancer Center 2014 Traineeship World Health Organization 2012 Internship Institute for Behavioral and Community Health 2009 Externship Washington Hospital Center (Washington, D.C.) 2008 Summer Medical and Dental Education Program Yale University and the Robert Wood Johnson Foundation
EMPLOYMENT 2018-Present Research Scientist & Academic Coordinator University of California, San Diego (La Jolla, CA) Manages UCSD’s responsibilities for the multi-site Regional Economic Development project, funded with a $2.1 million grant from the Economic Development Administration of the U.S. Department of Commerce, ensuring that deliverables are fiscally sound, produced with analytical accuracy, and delivered according to contractual deadlines Uses R and SPSS for data wrangling, macro programming, and advanced data analysis techniques, including multiple imputation, feature scaling, regression analysis, and structural equation modeling Uses ArcGIS for visualization of geospatial data, including advanced spatial analysis techniques such as feature localization and kriging interpolation Creatively describes complex statistical tests and detailed research findings in written manuscripts and non-technical oral presentations for internal managers and external funders Uses Tableau for dashboard design and creation, with data sources ranging from flat files, hosted spreadsheets, and application programming interfaces (APIs) that simultaneously convey easy-to- understand information about individuals, groups, and abstractions across spatial and temporal domains. Visualizations include maps, highlight tables, bar charts, line graphs, bubbles, scatterplots, tree maps, and others. Provides mentoring for students in the Master of Advanced Studies in Clinical Research, covering broad activities such as prospective mentor recruitment, mentor-mentee matching, student research counseling, and ensuring that students meet administrative milestones according to requirements from the department, school, and university levels. Mentoring experience spans medical students on NIH funding, foreign students on F1 and H4 visas, students transferring from non-degree programs in translational research, and students with pharmaceutical/clinical industry backgrounds. 2018-Present Officer, Medical Service Corps U.S. Navy Reserve (Coronado, CA) Works as Environmental Health Officer for the Medical Service Corps, providing health science expertise for defense operations of the United States Participates in training exercises covering high-level military operational procedures, including supply management, Veterans Administration policies, ethical guidelines, budgetary considerations, and safety practices 2017-Present Adjunct Faculty National University (La Jolla, CA) Instructor for Healthcare Administration 660 (Health Economics), covering healthcare financing mechanisms, provider incentives, risk assessment, supply and demand, elasticity, forecasting, profit maximization, price setting, price discrimination, asymmetric information, managerial interventions, profit analysis, market structures, market power, government intervention, regulatory pressures, and strategic behaviors. Graded essays, examinations, and oral presentations. Instructor for Healthcare Administration 663 (Health Finance and Accounting), covering reimbursement methods, income statements, balance sheets, statements of cash flows, fixed and variable costs, breakeven analysis, departmental cost allocation, service line costing, operating budgets, variance analysis, time value analysis, compounding and discounting, annuities and perpetuities, stand-alone and portfolio risks, debt financing, equity financing, required rates of return, stock valuation, capital structure theory, corporate costs of capital, ROI analysis, internal rates of return, sensitivity analysis, scenario analysis, Monte Carlo simulation, revenue cycle management, supply chain management, ratio analysis, and Du Pont analysis. Graded essays, examinations, and oral presentations. 2017-2018 Post-Doctoral Scholar University of California, San Diego (La Jolla, CA) For the funder Alliance for Safe Online Pharmacies (ASOP), used R to extract and analyze social media data to measure markers of prescription drug abuse. Spearheaded a project that conducts epidemiological analysis on medical complication rates of cancer medications using the FDA Adverse Events Reporting System (FAERS). Leveraged numerous statistical techniques for publication and grant writing efforts, including principal components analysis, structural equation modeling, data pooling for meta-analysis, factor analysis (both exploratory and confirmatory), outlier analysis, longitudinal data analysis, cluster analysis, power calculations, regression analysis (including linear, logistic, polychotomous, ordinal, stepwise, and Poisson), smoothed splines, discriminant analysis, and geospatial analysis (choropleth, heatmaps, Anselin Local Morans I, Getis Ord Gi*) Aligned and developed a research portfolio, and continuously grows portfolio in consonance with expected goals and outcomes. Drafts proceedings and findings in accordance with IRB protocols. 2014-2017 Graduate Research Associate University of California, San Diego (La Jolla, CA) Prepared scientific reports and presents original research funded by the UCSD Frontiers of Innovation Scholars Program, by assessing the global quantitative relationships between current/predicted estimates of cancer prevalence and accessibility to essential cancer medications, as designated by the WHO. Fulfilled aims of grant from the American Cancer Society for Geospatial Analysis of Counterfeit Avastin Data using ArcGIS software to conduct epidemiological analyses on the demographic correlates of cancer medication counterfeiting reports from the FDA. Presented at several national public health research conferences. 2015-2017 Technical Project Manager Luth Research (San Diego, CA) Created SPSS syntax scripts as part of central quality assurance procedures for delivery of data- oriented end-products to clients Programming of XML-based scripts using the python programming language to create web-based survey programs Used the SQL declarative programming language to query relational database management systems (Greenplum, Apache Hadoop HDFS) to support processing of digital online behavioral data from mobile application-based internet traffic and browser-based internet traffic Managed project workflow and coordinates the activities of team members to provide timely delivery of end contracted products Analyzed online internet-based behaviors to create/present market research reports for a wide range of clients, including Google, the City of Chula Vista, E.&J. Gallo Winery, Warner Brothers, and the Walt Disney Company 2014-2015 Epidemiologist & Biostatistician GrassrootsHealth (Encinitas, CA) Used R and SAS software to aid in descriptive epidemiological analysis of cohort data, assessing impact of solar exposure parameters and serum 25-hydroxyvitamin D metabolites on both non- communicable diseases and infectious diseases. Analyzes data on a cohort of participants maintained by GrassrootsHealth, including assessments of co-morbid chronic medical conditions. Presents epidemiological assessments which quantify the relationship between serum 25- hydroxyvitamin D with chronic pain, arthritis, pregnancy complications, cardiovascular disease, and influenza. Prepares scientific reports and reviews molecular biology literature on PubMed to uncover reported etiological mechanisms that may underlie epidemiological findings. 2013-2014 Teaching Assistant & Research Assistant San Diego State University (San Diego, CA) For Public Health 647 (Quantitative Methods of Data Analysis), administered lectures and graded assignments to Masters-level students and instructed/coordinated computer lab sessions. Covered statistical theory and procedures with the SPSS statistical program, in application to healthcare administration data. For Public Health 780 (Global Health I), graded Doctoral-level assignments, provided coordination, and administered lectures. Provided specific expertise on non-communicable disease epidemiology and etiology. For Public Health 781 (Global Health II), graded Doctoral-level assignments, provided coordination, and administered lectures. Provided specific expertise on economic analysis methodologies in global health frameworks/settings. For Health and Human Services 350 (Applied International Health and Human Services), took Bachelor-level students to Costa Rica, coordinated global health immersion exercises and experiences, and provided instruction regarding international health systems. Traveled to Ho Chi Minh City, Vietnam, to assist in conducting a psychosocial intervention for children with co-morbid chronic medical conditions, specifically HIV and emotional distress. Used questionnaires to assess a battery of psychosocial conditions, including suicidality and social level of functioning. Emphasized the systematic process of intervention-oriented scientific methodology when supervising a team of three Vietnamese data collectors to attain baseline data for longitudinal records. 2012-2014 Epidemiologist and Life Scientist Leidos (San Diego, CA) Used SAS to create regression-based models of the relationship between cancer (colorectal, pancreatic, and leukemia) incidence and meteorological proxy measures for biological risk factors, adjusting for numerous factors of socioeconomic population-level development. Used JMP and ArcGIS software for data visualization. Analyzed data using multiple data types and sources, including published serum 25-hydroxyvitamin D data and longitudinal records. Applied several regression-based approaches, methodologies, and statistics, involving etiologic research; prevalence and incidence; hazard ratios; quantifying relationships; ascertained environmental factors; analytical research; evaluated changes; measured health markers; and conducted epidemiological analyses. Goals achieved include analyzing impact; supporting development of a portfolio of research programs; and growing a portfolio in consonance with expected goals and outcomes, following NHRC, Navy, and DoD research requirements. In continued collaboration with NHRC researchers, conducted epidemiological analyses of longitudinal records of influenza infection in in military personnel. Developed several manuscripts for medical publications which were published in peer-reviewed academic journals. By presenting research findings at several conferences, supported the translational migration of findings into practical applications, including the clinical measurement of 25-hydroxyvitamin D as a component of cancer risk. 2010-2011 Research Assistant Lafayette College Department of Biology (Easton, PA) Ascertained environmental factors—biotic (macroinvertebrate communities) and abiotic (pH and oxygen saturation)—from tributaries of the Delaware River in order to evaluate changes in water quality in tandem with dam removal. Was awarded research funding support from the Andrew W. Mellon Foundation.
2009-2011 America Reads Tutor Lafayette College (Easton, PA) Taught basic literacy and numeracy skills to preschool- and elementary-aged schoolchildren
OTHER PROFESSIONAL ACTIVITIES 2017–present Fellow, Royal Society for Public Health 2014–present Senior Research Associate, Global Health Policy Institute 2017–2018 Member, National Postdoctoral Association 2012–2015 Member, American Public Health Association 2012–2015 Member, American College of Healthcare Executives 2012–2015 Member, AcademyHealth 2012–2015 Member, Academy of Management 2012–2015 Member, San Diego Organization of Healthcare Leaders
SERVICE 2013-2014 Doctoral Representative, Student Council Graduate School of Public Health, San Diego State University, San Diego, CA 2012-2013 Treasurer, Student Council Graduate School of Public Health, San Diego State University, San Diego CA 2011-2012 Health Management and Policy Representative, Student Council Graduate School of Public Health, San Diego State University, San Diego, CA 2011 Senior Care Volunteer Landis Community Outreach Center, Lafayette College, Easton, PA 2009 Volunteer Coordinator of H1N1 Vaccination Clinic Landis Community Outreach Center, Lafayette College, Easton, PA 2008 Committee Leader Lafayette Environmental Awareness and Protection, Lafayette College, Easton, PA 2007-2008 Childcare Volunteer Landis Community Outreach Center, Lafayette College, Easton, PA 2007 Emergency Room Volunteer Easton Hospital, Easton, PA 2007 OB/GYN Volunteer St. Luke’s Hospital, Bethlehem, PA 2007 Childcare Volunteer St. Paul Elementary School, Los Angeles, CA 2004-2006 Hospital Volunteer St. John’s Health Center, Los Angeles, CA HONORS 2017 Fellow, Royal Society for Public Health 2017 Awardee, Who’s Who in the World 2015 Fellowship, UCSD Frontiers of Innovation Scholars Program 2014 Traineeship, International Agency for Cancer Research, World Health Organization 2014-2015 Scholarship (twice awarded), Transdisciplinary Research on Energetics and Cancer 2014 Inductee, Delta Omega Honorary Society in Public Health 2013 Distinguished Service Cord, San Diego State University 2008–2011 National SMART Grant, Lafayette College 2010 Mellon Scholar, Andrew W. Mellon Foundation 2008 SMDEP Alumnus, Robert Wood Johnson Foundation 2007–2008 Academic Competitiveness Grant, Lafayette College 2006 Eagle Scout Award, Boy Scouts of America
TEACHING 2018 Instructor, National University Healthcare Administration 660, Health Economics 2018 Instructor, National University Healthcare Administration 663, Health Finance and Accounting 2017 Instructor, National University Healthcare Administration 660, Health Economics 2014 Teaching Assistant, San Diego State University Health and Human Services 350, Applied International Health and Human Services 2014 Invited Academic Talk, UCSD Human Nature Group Economic Analysis of a Vitamin D Intervention on Colorectal Cancer 2014 Teaching Assistant, San Diego State University Public Health 781, Global Health II 2013 Teaching Assistant, San Diego State University Public Health 780, Global Health I 2013 Teaching Assistant, San Diego State University Public Health 647, Quantitative Methods of Data Analysis 2013 Invited Lecture, SDSU Graduate School of Public Health Student Council The Certified in Public Health Exam
CERTIFICATIONS 2015-present HIPAA Certified UCSD Human Research Protections Program 2013-present Certified in Public Health National Board of Public Health Examiners 2006-present CPR and AED Certified American Heart Association
PEER-REVIEWED PUBLICATIONS 22. Cuomo RE, Mackey TK. (2018). Policy and governance solutions for ensuring equitable access to cancer medicines in low- and middle-income countries. Annals of Translational Medicine 6(11). 21. Cuomo RE, Seidman RL, Mackey TK. (2017). Country and regional variations in purchase prices for essential cancer medications. BMC Cancer 17(1): 566. 20. Cuomo RE, Mackey TK. (2017). The availability of essential cancer medication: An analysis of national formularies. Journal of Cancer Policy 12:49-54. 19. Katsuki T, Mackey TK, Cuomo RE. (2016). Digital surveillance of prescription drug abuse: An accessible Annals of Global Health methodology for collecting and analyzing Twitter NUPM data. 82(3): 590. 18. Cuomo RE, Mackey TK. (2016). Macroeconomic factors underlying essential cancer medication availability Annals of Global Health among low- and middle-income countries. 82(3): 328-329. 17. Mackey TK, Katsuki T, Cuomo RE. (2015). Establishing a link between prescription drug abuse and illicit Journal of Medical Internet Research online pharmacies: Analysis of Twitter data. 17(12): e280. 16. Cuomo RE, Garland CF, Gorham ED, Mohr SB. (2015). Low cloud cover-adjusted ultraviolet B irradiance is PLOS One associated with high incidence rates of leukemia: Study of 172 countries. 10(12): e0144308. 15. Cuomo RE, Miner A, Mackey TK. (2015). Pricing and sales tax collection policies for e-cigarette starter kits Drug and Alcohol Review and disposable products sold online. 35(1). 14. Mackey TK, Miner A, Cuomo RE. (2015). Exploring the e-cigarette e-commerce marketplace: Identifying Drug and Alcohol Dependence Internet e-cigarette marketing characteristics and regulatory gaps. 156. 13. Baggerly CA, Cuomo RE, French CB, Garland CF, Gorham ED, Grant WB, Heaney RP, Holick MF, Hollis BW, McDonnell SL, Pittaway M, Seaton P, Wagner CL, Wunsch A. Sunlight and vitamin D: Journal of the American College of Nutrition Necessary for public health. 34(4): 359-365. 12. Mackey TK, Cuomo RE, Liang BA. (2015). The rise of digital direct-to-consumer advertising?: Comparison of direct-to-consumer advertising expenditure trends from publicly available data sources and global policy BMC Health Services Research implications. 15:236. 11. Cuomo RE, Mackey TK, Stigler P. (2015). The economics of counterfeit Avastin: A geospatial and statistical analysis of demographic correlates to FDA warning letters. Pharmacoepidemiology & Drug Safety 24(7): 748-56.
10. Garland CF, Cuomo RE, Gorham ED, Zeng K, Mohr SB. (2015). Cloud cover-adjusted ultraviolet B irradiance and pancreatic cancer incidence in 172 countries. The Journal of Steroid Biochemistry and Molecular Biology ; 155(Pt B): 257-263. 9. Cuomo RE, Mackey TK. (2015). Determining demographic risk factors for receiving counterfeit cancer Annals of Global Health drugs. 81(1):65. 8. Mackey TK, Cuomo RE, Guerra C, Liang BA. (2015). After counterfeit Avastin®-what have we learned Nature Reviews Clinical Oncology and what can be done? 12: 302-308. 7. Gorham ED, Cuomo RE, Mohr SB, Garland CF. (2014). Association between 25-hydroxyvitamin D and Lancet Diabetes & Endocrinology type 2 diabetes? 3(1): 11 6. Mohr SB, Gorham ED, Garland CF, Grant WB, Garland FC, Cuomo RE. (2014). Are low ultraviolet B and vitamin D associated with higher incidence of multiple myeloma? The Journal of Steroid Biochemistry and Molecular Biology 148: 245-252. 5. Mohr SB, Kim J, Hofflich H, Cuomo RE, Garland CF. (2014). Could vitamin D sufficiency improve the survival of colorectal cancer patients? The Journal of Steroid Biochemistry and Molecular Biology 148: 239- 244.
4. Cuomo RE, Mackey TK. (2014). An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain. BMJ Open 4(12).
3. Mackey TK, Liang BA, Cuomo RE, Hafen R, Brouwer KC, Lee D. (2014). Emerging and re-emerging neglected tropical diseases: A review of key characteristics, risk factors, and the policy and Clinical Microbiology Reviews innovation environment. 27(4): 949-979. 2. Cuomo RE, Baek JD. (2014). The global association between maternal mortality and skilled The Journal of Global Health Care Systems health workers. 4(1). 1. Cuomo RE, Mohr SB, Gorham ED, Garland CF. (2013) What is the relationship between ultraviolet B irradiance and global incidence rates of colorectal cancer? Dermato-Endocrinology 5(1): 181-185.
BOOKS 1. Cuomo RE. (2011). Public Health Perceptions of American Youth. Bloomington, Indiana. ISBN 160481909X
SOFTWARE 3. Cuomo RE. (2014). SOHL (i.e. “San Diego Organization of Healthcare Leaders”). iPhone Application. Cupertino, CA: Apple Inc. 2. Cuomo RE. (2012). PubHealth News. iPhone Application. Cupertino, CA: Apple Inc.
1. Cuomo RE. (2012). GSPH (i.e. “Graduate School of Public Health”). iPhone Application. Cupertino, CA: Apple Inc.
CONFERENCE PRESENTATIONS 21. Mackey TK, Seidman RL, Cuomo RE. (2017). Global inequality in purchase prices for essential cancer medications. American Public Health Association Annual Meeting. Poster presentation. 20. Katsuki T, Mackey TK, Cuomo RE. (2016). Digital surveillance of prescription drug abuse: An accessible methodology for collecting and analyzing twitter NUPM data. Consortium of Universities for Global Health. Poster presentation. 19. Cuomo RE, Mackey TK. (2016). Macroeconomic factors underlying essential cancer medication availability among low- and middle-income countries. Consortium of Universities for Global Health. Poster presentation. 18. Cuomo RE. (2015). Access and affordability of cancer drugs in international settings. Frontiers of Innovation Scholars Program Symposium. Oral presentation.
17. Mackey TK, Liang BA, Cuomo RE, Ryan H, Dan L, Brouwer KC. Emerging and reemerging neglected tropical diseases: Review of key characteristics and risk factors. American Public Health Association Annual Meeting . Poster presentation. 16. Cuomo RE, Miner A, Mackey TK. (2015). Pricing and sales tax collection policies for e-cigarette starter kits and disposable products sold online. American Public Health Association Annual Meeting. Poster presentation.
15. Cuomo RE, Mackey TK. (2015). Economics of counterfeit Avastin: A geospatial and statistical analysis of demographic correlates to FDA warning letters. American Public Health Association Annual Meeting. Poster presentation.
14. Garland CF, Cuomo RE, Gorham ED, Zeng K, Mohr SB. (2015). Cloud cover-adjusted ultraviolet B irradiance and pancreatic cancer incidence in 172 countries. San Diego Epidemiology Exchange. Oral presentation. 13. Mackey TK, Cuomo RE, Guerra J. (2015). Counterfeit cancer medicines: Economic analysis of University of California Global Health Day counterfeiting. . Oral presentation. 12. Cuomo RE, Mackey TK. (2015). Potential demographic and economic risk factors for receipt of counterfeit cancer medication. Consortium of Universities for Global Health. Poster presentation.
11. Cuomo RE, Mackey TK. (2014). Determining demographic risk factors for receving counterfeit cancer th drugs. 8 Annual Health Disparities Conference. Poster presentation. 10. Cuomo RE, Garland, CF. (2014). Are higher incidence rates of organ cancers in the Pampas region of South America related to consumption of maté tea? American Institute for Cancer Research. Poster presentation. 9. Mackey TK, Cuomo RE. (2014). Where is the counterfeit Avastin? 2014 Esri User Conference. Oral presentation.
8. Cuomo RE, Garland, CF, Gorham ED, Zeng K, Mohr SB, MCDonnell S, Baggerly L. (2014). Low cloud cover-adjusted ultraviolet B irradiance is associated with high incidence rates of leukemia: study of 170 th countries. The 17 Vitamin D Workshop. Poster presentation. 7. Mohr SB, Gorham ED, Garland CF, Cuomo RE, Baggerly C. (2014). Multiple myeloma is associated with th low ultraviolet B irradiance and high latitude in 170 countries. The 17 Vitamin D Workshop. Poster presentation. 6. Garland CF, Gorham ED, Creswell G, Cuomo RE, Mohr SB, Hofflich H, Baggerly C. (2014). Computer th model of vitamin D prevention of breast and colon adenocarcinoma: D3INOMIT. The 17 Vitamin D Workshop. Poster presentation. 5. Gorham ED, Cuomo RE, Garland CF, Zeng K, Mohr SB, McDonnell S, Baggerly C. (2014). Low cloud cover-adjusted ultraviolet B irradiance is associated with high incidence of pancreatic cancer worldwide. th The 17 Vitamin D Workshop. Poster presentation. 4. Cuomo RE, Gorham ED, Mohr SB, Garland CF. (2013). Are low UVB and vitamin D deficiency San Diego Research Exchange associated with increased leukemia risk? . Oral presentation. 3. Cuomo RE, Baek JD. (2013). Analyzing the global relationship between maternal mortality and scarcity of skilled healthcare workers. San Diego State University Student Research Symposium. Oral presentation. 2. Cuomo RE, Lopez NV. (2013). Economic analysis of a clinic-based childhood overweight intervention. Science of Eliminating Health Disparities . Poster presentation. 1. Cuomo RE, Lopez NV, Crespo NC, Elder JP. (2012). Body fat percentile curves for Latino children. San Diego Organization of Healthcare Leaders Annual Conference. Poster presentation.
MEDIA 4. Research Feature. “Online E-Cigarette Vendors Engage Customers Using Popular Internet Tools.” Newsroom , UC San Diego Health. 2 October 2015. 3. Research Feature. “Pancreatic cancer risk linked to weak sunlight.” EurekAlert!, American Association for the Advancement of Science. 30 April 2015. 2. Research Feature. “Fake Avastin incident ‘could happen again.’” Securing Industry, SecuringIndustry.com. 7 April 2015. 1. Feature. “Students Led Local Fight Against Swine Flu: Raphael Cuomo ’11 headed efforts to recruit students and staff an area vaccination clinic.” News, Lafayette College. 6 January 2010.
GRANTS U.S. Economic Development Administration (PI: Timothy Slaper) 03/26/2018–Present Regional Economic Development Role: Research Scientist
Alliance for Safe Online Pharmacies (PI: Timothy Mackey) 03/25/2017–01/01/2018 Assessing the Role of Social Media in Promoting Prescription Drug Abuse Role: Post-Doctoral Scholar
UCSD Frontiers of Innovation Scholars Program (PI: Timothy Mackey) 03/01/2015–03/24/2017 Access and Affordability of Cancer Drugs in International Settings Role: Pre-Doctoral Fellow
American Cancer Society (PI: Timothy Mackey) 03/15/2014–12/31/2014 Geospatial Analysis of Counterfeit Avastin Data Role: Graduate Research Assistant
Navy Bureau of Medicine and Surgery (PI: Cedric Garland) 11/15/2012–02/28/2014 Global Models of Variations in Cancer Incidence Role: Contracted Epidemiologist
Lafayette College & Andrew W. Mellon Foundation (PI: Megan Rothenberger) 07/2010–05/2011 Think Tank Multi-Pilot Capstone Grant Role: Research Assistant Macroinvertebrate
DILESH DOSHI, PHARMD
● +1 949 887 7488 ● [email protected] ● LinkedIn Profile
EDUCATION
Harvard Business School, Boston, MA Strategy for Healthcare Delivery & Leadership, Certificate of Completion, 2017
Thomas Jefferson University, Philadelphia, PA Health Economics, 2-yr Post Graduate Research Fellowship, 1998-2000
Univ. of California, San Francisco, School of Pharmacy Doctor of Pharmacy, 1994-1998
Central Connecticut State Univ., New Britain, CT BS Chemistry, 1989-1993
SUMMARY
Over my 20 years in the pharmaceutical industry as a health economics and market access leader, I have successfully built new and innovative capabilities and departments, recruited and managed high performing teams, and collaborated with commercial and governmental stakeholders to generate meaningful evidence to obtain access and reimbursement for transformational products. Utilizing my expertise in real world data, health economics, market access, and reimbursement policies I have developed evidence generation and market access strategies that achieve optimal access, positive Health Technology Assessments (HTAs) and reimbursement of products in the US & global markets.
I have extensive customer facing experience that has resulted in successful partnerships co- generating evidence and obtaining favorable reimbursement decisions across diverse set of managed markets customers. I have developed and maintained strategic alliances with health systems and national policy organizations to drive the debate on future policies and positively affect change. With over 70 podium presentations and peer reviewed publications including book chapters, manuscripts, white papers, and posters, I am recognized nationally as a subject matter expert and regularly invited as a speaker at National and International conferences. I have also been appointment by Unv. of California San Diego to teach Master’s and Doctorate level students health economics and policy as we transition to value based healthcare.
CORE COMPETENCIES
Demonstrated ability to build and align teams around critical organizational strategies Successful in influencing senior executive leadership in a matrix environment Strong understanding of changing healthcare trends that impact access decisions Extensive client facing experience for access negotiations across leadership levels Developed integrated evidence plans for diverse group of external stakeholders Experience with value dossiers, economic modeling, HTAs, and PROs Page 1 of 8 CV - Dilesh Doshi, PharmD
PROFESSIONAL EXPERIENCE
Senior Director, Health Economics & Outcomes Research and Biostatistics Actelion Pharmaceuticals (Janssen), December 2018 – Present
Specially appointed by Scientific and Medical executive leadership to build and integrate Actelion US Health Economics inhouse and field-based teams as well as US Biostatistics function for rare diseases and ensure seamless integration in the J&J structure post- acquisition. Tasked to map business needs to HEOR capabilities, create organizational structure with appropriate job titles and compensation levels, recruit and align staff to critical business initiatives, develop standard operating policies (SOPs) in compliance with current guidances, develop and execute integrated evidence and reimbursement plans.
In collaboration with Chief Scientific Officer of Janssen and President of Actelion US, developed a restructuring and HEOR growth plan to meet business objectives Coordinate with Global Market Access teams to ensure align of value messages, submission responses, and real-world evidence generation plans Ensure compliant vendor management to attain timely deliverables Develop relevant SOPs for generation and dissemination of RWE
Senior Director, Population Health Research, Janssen Pharmaceuticals (J&J), October 2015 – December 2018
Responsible for building am entirely new function and team focused on Population Health supporting all six Janssen business units. Developed and directed market access scientific strategy and analytic function in alignment with healthcare system transformation from fee for service to value-based payment model. Developed evidence generations plans for improving models of clinical care by focusing on evidence that is predictive, proactive, preventive, and personalized.
Build and manage a team of MD, PharmD, and PhD level subject matter experts Generate key insights and develop frameworks for go to market strategies Execute demonstration projects with large health systems Work with Janssen Americas Leadership Team (JALT) and Operating Company Presidents to align business plans and metrics Executed first in industry collaboration with National Committee on Quality Assurance (NCQA) for Population Health Management standards.
Associate Clinical Professor Pharmacoeconomics, Skaggs School of Pharmacy University of California, San Diego, CA, Apr 2009 – Present
Voluntary appointment recommended by the Dean Lecturer for multiple courses for PY1-4 Pharmacy students Precept pharmacy students for the Pharmacoeconomics courses Pharmacoeconomics advisor for master’s level degree program focussed on drug development and product management Mentor students for non-traditional residences and fellowships
Page 2 of 8 CV - Dilesh Doshi, PharmD
Director, Translational Science - Health Economics Janssen Pharmaceuticals, Nov 2009 – Oct 2015
Lead a team of researchers to generate real world data to support the value proposition for the portfolio of products in the areas of schizophrenia, Hep C, Immunology, and oncology. Support payers to translate clinical trial and real-world data into clinical practice.
Strategic and operational oversight for the team Acquire unique datasets to analyze value of Janssen products in real world setting Develop systematic evidence planners per PCORI guidelines Generate payer specific evidence to support reimbursement appraisals Present economic value propositions to health authorities Partner with Market Access teams to support product value proposition and access Lead development, reviews & approvals of field base economic tools and models
National Director, Field Outcomes Research, 3/06 – 11/09 Associate Director, Field Outcomes Research, 11/01 – 3/06 Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ.
Manage a field-based research team responsible for executing health economics and outcomes research projects by collaborating with external stakeholders including managed care organizations, employer groups, and various Federal and State government agencies.
Accountable for the field based HEOR function for Janssen Neuroscience Portfolio Translate business plans in evidence generation and evidence synthesis objectives Develop economic models to support product value strategy Collaborate with Market Access to provide input into the reimbursement strategy Lead the development of customer-focused solutions and tools such as quality improvement tools, medication use evaluation software, MTM programs, etc. Recruit and manage a group of 6-8 field-based health economists
Chair, Johnson & Johnson Global Field Medical Affairs Council (2008-2009)
Lead a global group of senior managers from various J&J Operating Companies to develop and share policies and procedures for field based Medical Affairs function. In collaboration with the Global Medical Affairs Council (GMAC), develop goals and objectives as well as provide progress update to Senior Medical Affairs personnel across J&J businesses.
Associate Director, Global Health Economics & Outcomes Research (EMEA) AstraZeneca Pharmaceuticals, Wilmington, DE, Jul 2000 – Nov 2001
Responsibilities included global health economics and outcomes research support for Phase I – IV neuroscience portfolio. Contributed to the global clinical development plan as well as the commercial, pricing, and marketing strategy for Seroquel.
Conduct prospective & retrospective research measuring economic, clinical, & PROs Present health outcomes data at advisory boards Consult on pricing and commercialization strategy Influence a multitude of diverse internal stakeholders
Page 3 of 8 CV - Dilesh Doshi, PharmD
Fellow, Global Health Economics & Pricing (Australia & New Zealand) SmithKine Beecham, Collegeville, PA Jul 1999 – Jun 2000
Provide health economics and pricing support for Ariflo to Aus/NZ affiliate including preparation for PBAC submission
PUBLICATIONS (Posters, Manuscripts, and Book Chapters)
NCQA-Janssen Population Health Management Resource Guide. June 2018.
Greenwood KL, LaMori JL, Doshi D., et al. Impact of Behavioral Health Screening on Proactive Identification of Patients at Risk for Hospital Readmission. Population Health Management, July 2018, Vol pgs 24-29
Romanelli R, LaMori JL, Doshi D., et al. Patients’ Medication-Related Experience of Care Is Associated with Adherence to Cardiometabolic Disease Therapy in Real-World Clinical Practice. Population Health Management, May 2018, Vol pgs 34-38
Greenwood K., LaMori JL, Doshi D, et al. Can Behavioral Health Data Improve the Accuracy of a Model to Predict CMS HRRP Readmissions? Poster accepted at American Psychiatry Association Annual Meeting, May 2018, New York, New York.
Adome A, Doshi D, Liberman J. Research Partnership Tackle Population Health Management Challenges. CAPG Health, Annual Conference Issue. June 2017
Greenwood K., LaMori JL, Doshi D, et al. Can Behavioral Health Data Improve the Accuracy of a Model to Predict Hospital Patient Readmissions? Poster presented at Academy Health Research Meeting, June 2017, New Orleans, LA
McClelan M., Leavitt M., et al. ACLC White Paper: A Call for Collaborative Action: Achieving Readiness for a Value Payment World. Contributing Author. September 2016.
Pesa JP, Baser O, Doshi D., et al. Health care resource utilization and costs of California- Medicaid patients with schizophrenia treated with paliperidone palmitate once monthly or atypical oral antipsychotic treatment. Current Medical Research and Opinion. Jan 2017
Romanelli R, LaMori JL, Doshi D., et al. Patients’ Involvement in Treatment Decision- Making is Associated with Improved Adherence to Chronic Disease Medications. Podium presentation at the 38th Annual Society of Medial Decision Making Conference. Vancouver, BC, Oct 26th 2016.
Lutchman G., Nguyen MH, Doshi D., et al. Effectiveness & Tolerability of Simeprevir and Sofosbuvir in Nontransplant and Post-liver Transplant Patients with Hepatitis C Genotype 1. Alimentary Pharm & Therapeutics Volume 44, Issue 7, Oct 2016, Pgs 738–746
Schwartz AL, Grabowski DC, Doshi D., et al. Medicaid Managed Care Penetration and Drug Utilization for Patients with Serious Mental Illness. AJMC, Vol 22 No 5 pg 294-301
Page 4 of 8 CV - Dilesh Doshi, PharmD
LaMori JC., Doshi D., Devlin F., McAlister D. Use of a Mobile Health Management Application to Manage Multiple Chronic Disease Medications. ISPOR May 2016 Annual Conference, Washington DC, USA
Pesa JP, Doshi D, Wang Li. Comparing Costs and Resource Utilization in Patients With Schizophrenia Treated With Paliperidone Palmitate or Oral Atypical Antipsychotics and Enrolled in California Medicaid. Presented at the 28th Annual US Psychiatric and Mental Health Congress; September 10–13, 2015; San Diego, California
Pesa JP, Doshi D, Baser O. Outcomes Among Schizophrenia Patients Recently Hospitalized or Nonadherent to Antipsychotic Therapy. APA, May 2016.
Pesa JP, Doshi D, Wang Li. Description of Healthcare Resource Utilization and Costs in Young, Recently Diagnosed Patients With Schizophrenia 12 Months Prior to Treatment With Injectable Paliperidone Palmitate Once-Monthly. Academy of Managed Care Pharmacy, May 2016.
Shimoto M., Doshi D., et al. Analyzing the Burden of Hepatitis C Using an Outcomes Evaluation Tool Within an IDN. AMCP Spring 2015, San Diego, CA
Morrato E., Doshi D., et al. Comparative effectiveness of injectable paliperidone palmitate versus oral atypical antipsychotics: early postmarketing evidence. Journal of Comparative Effectiveness Research, October, 2014
Mueller C., Doshi D., Impact of Coverage Policies on Access to Anti-psychotic Drug Paliperidone Palmitate. American Journal of Pharmacy Benefits, July/August 2014 Lafeuille, Gravel, Fastenau, Muser, & Doshi D. Patterns of Relapse and Associated Cost Burden in Schizophrenia Patients Receiving Atypical Antipsychotics. JME: Journal of Medical Economics Manuscript ID: 841705
Ishisaka D, Romanelli R., Doshi D., et al. Utilization of Infliximab in the Treatment of IBD in an Ambulatory Care Network in Northern California. AMCP Annual Meeting, April 2013, San Diego, CA.
Bolge S., Doshi D., et al. Patient Satisfaction and Experience with Golimumab, Adalimumab, and Eternacept for the Treatment of RA, PsA, and AS. American College of Rheumatology, November, 2012
Ellis L., Doshi D., et al. Utilization and Expected Cost of RA Patients Treated with Golumumab: A Specialty Pharmacy Perspective. American College of Rheumatology, November, 2012
Ellis L., Doshi D., et al. Characteristics of Golimumab Utilization and Costs in a Specialty Pharmacy Providers (SPP) Setting. ISPOR, Baltimore, MD, 2011
Edwards, N, Muser EM, Doshi D, Fastenau, J. The threshold rate of oral atypical anti- psychotic adherence at which paliperidone palmitate is cost saving. Journal of Medical Economics, Vol. 15, No. 4, 2012, 1–12
Pesa JA, XS Ren, Doshi D. Timing of Prescribing Risperidone Long-Acting Therapy (RLAT) and Outcomes among Newly-Diagnosed Schizophrenia Patients in the Veterans Health Administration. American Psychiatry Association, 2012, Philadelphia, PA
E Muser, E Campagna, J Parks, D Doshi, J Newcomer, E Morrato. Drug Utilization of Paliperidone Palmitate in Medicaid Patients. APA, May 2012, Philadelphia, PA
Page 5 of 8 CV - Dilesh Doshi, PharmD CS Mueller, J Silver, A Bartels, D Doshi. Impact of Coverage Policies on Patient Access to Treatment by Paliperidone Palmitate. American Psychiatry Association, May 2012, Philadelphia, PA
Karve, S, Muser E, Doshi, D, et al. Prescription Utilization Patterns of Paliperidone Palmitate Among Medicaid Enrollees. US Psychiatry Congress, Nov., 2011, Las Vegas, NV.
Forlenza J, Boswell E, Doshi D, et al. Factors Associated With Overall and Non- Elective Hospital Readmissions Following Elective Total Hip Replacement. Society for the Advancement of Blood Management 2011 Annual Meeting, September 22-24, 2011; Philadelphia, PA.
Forlenza J, Boswell E, Doshi D, et al. Factors Associated With Overall and Non- Elective Hospital Readmissions Following Elective Total Knee Replacement. Society for the Advancement of Blood Management 2011 Annual Meeting, September 22- 24, 2011; Philadelphia, PA.
Mueller CS, Doshi D, et al. Clinical Characteristics and Healthcare Costs of Rheumatoid Arthritis Patients Who Switch Anti-TNF Agents. AMCP October 2010, St Louis, MO
Page MJ, Paramore CL, Doshi D, et al. Burden of Migraine in the Employer Setting. Journal of Health and Productivity. May 2009. 3-9
Page MJ, Paramore CL, Doshi D, et al. Evaluation of Resource Utilization and Cost Burden Before and After an Employer-Based Migraine Education Program. Journal of Occupational & Environmental Medicine. 51(2):213-220, February 2009.
Page MJ, Paramore CL, Doshi D, et al. Screening for Migraine in the Workplace. Journal of health and productivity, VOLUME 3, NUMBER 2 • December, 2008
Dickson M., Bramley T., Doshi D., et al. Potential drug–drug interactions with antiepileptic drugs in Medicaid recipients. AJHP. 2008; 65:1720-6
Schein J, Doshi D., et al. A comparison of levofloxacin and moxifloxacin use in hospitalized community acquired pneumonia (CAP) patients in the US: focus on length of stay. CMRO; Vol. 24, No. 3, 2008, 895–906
Ye X., Sikirica V., Doshi D., et al. Treatment Failure Rates and Health Care Utilization Among Patients with Community Acquired Pneumonia Treated with Levofloxacin or Macrolides in an Outpatient Setting. Clin Ther, 30:2; Feb 2008
Paramore CL, Doshi D, et al. Cost of Migraine Stratified by Migraine Disability Assessment Score (MIDAS) in the Workplace. Presented at the AHS Annual Conference, Chicago, IL, 2007.
Page MJ, Paramore CL, Doshi D, et al. Cost of Migraine Stratified by Prevention Need Status in an Employer Setting. Presented at the AHS Annual Conference, Chicago, IL, 2007.
Janagap C, Schein J, Doshi D, et al. Outcomes Associated With Levofloxacin and Moxifloxacin in Hospitalized Community-Acquired Pneumonia (CAP) Patients. Presented at the American Thoracic Society Spring Conference, San Francisco, CA, 2007.
Page 6 of 8 CV - Dilesh Doshi, PharmD Yi X, Sikirica V, Doshi D, et al. Treatment Failure Among Community Acquired Pneumonia Patients Treated with Levofloxacin or Macrolides in an Outpatient Setting. ISPOR 12th Annual International Meeting Arlington, Virginia, US May 2007
Bramley T, Meissner B, Doshi D, et al. Exposure Rate to Potential Drug Interactions with Antiepileptic Drugs in Patients with Epilepsy (Medicaid). Presented at the AAN Spring Conference, Boston, MA, 2007.
Paramore CL, Page MJ, Doshi D, et al. Burden of Migraine in Employer Setting. Presented at the AAN Spring Conference, Boston, MA, 2007.
Paramore CL, Page MJ, Doshi D, et al. Screening for Migraine in an Employer Setting. Presented at the AAN Spring Conference, Boston, MA, 2007.
Bramley T, Meissner B, Doshi D, et al. Exposure Rate to Potential Drug Interactions with Antiepileptic Drugs in Patients with Epilepsy. Presented at American Epilepsy Society Conference, San Diego, CA. December 2006
Janagap C, Schein J, Doshi D, et al. Comparison of demographics, length of stay, and resource utilization in hospitalized community acquired (CAP) patients treated with levofloxacin or moxifloxacin. Presented at the Association Health Systems Pharmacists Conference, Anaheim, CA, December 2006
Doshi D, Shetty S, Kadlubek P, Meletiche D. Real-World Utilization of Acetylcholinesterare Inhibitos and Memantine: A 6-Month Analysis of a National Managed Care Claims Database. ASCP, Boston, MA Nov. 11th, 2005.
Ramaswamy K, Amatniek J, Doshi D, et al. Safety of Galantamine – Memantine Combination Treatment for Mild to Moderate Alzheimer’s Disease. APA – IPS, San Diego, CA, Oct 7th, 2005
White AG, Birnbaum H, Doshi D, et al. Health Care and Work Loss Costs of Opioid Abuse Among an Employed Population in the US. ISPOR 10th Annual Conference, May 17, 2005, Washington, DC.
Sikirica V, Vallow S, Schein, J, Doshi D, et al. Prevalence, Co-Morbidities and Utilization of Services of Opioid Abusers in a Managed Care Plan. AAPM, Palm Springs, CA. Feb. 2005
White A, Birbaum H, Doshi DP, et al. Direct Costs of Opioid Abuse Among an Insured Population in the U.S. ASHP Midyear Clinical Meeting, Orlando, FL, December 5-9, 2004
White A, Birbaum H, Doshi DP, et al. Opioid Abuse Among an Insured Population in the US – Injury Condition Profile and Direct Costs. American Public Health Assc (APHA) meeting, Washington DC, November 6 – 10, 2004.
Mangin EFM, Jones WN, Wendel CS, Doshi DP. Retrospective Database Review of Healthcare Utilization in Patients with Dementia in a Veterans Affairs Healthcare System. AMCP Educational Conference, Baltimore, MD. October 15, 2004.
Vallow S, Ollendorf D, Howell J, Katz N, Doshi D. Costs of Emergency Room Visits and Hospitalizations for Opioid Abuse and Overdose in Patients in a Managed Care Population. IPCD,Chicago, IL. February 2004.
Juzba M, Doshi DP. Prescribing Patterns of Fentanyl Transdermal System and Oxycodone Hydrochloride Controlled-Release Tablets In A Managed Care Population. Page 7 of 8 CV - Dilesh Doshi, PharmD ASHP, December 2002.
Wilson L, Huang J, Doshi DP. Health Care Burden and Cost of Parkinson's Disease. Value in Health. 2000
Meletiche DM, Doshi DP, Lofland JH. MOS SF – 36: A Possible Source of Utilities? Clinical Therapeutics. 1999:21;11 pp 2016-26
Chatterton ML, Doshi DP, et al: Quality Improvement and Outcomes Measurement. In Diecidue RJ, Streck PD (eds): Oral and Maxillofacial Surgery Clinics of North America. Philadelphia, WB Saunders & Co, August 1999, pp 441 - 452.
Doshi DP. Resource Allocation in an HMO: Whose Perspectives Count? Pharmacoeconomics and Outcomes News. 1999:215; pp 3-4.
PROFESSIONAL LICENSE
Registered Pharmacist – California (Active since 1998)
Page 8 of 8 CV - Dilesh Doshi, PharmD Program Director/Principal Investigator (Last, First, Middle):
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME POSITION TITLE: Director, Strategic Academic Program Ettouati, Williams S. Development Support Team eRA COMMONS USER NAME (credential, e.g., agency login) Managing Director, MS in Drug Development an PM Health Sciences Associate Clinical Professor, N.S
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) Mathematics and Lycée Hélene Boucher, Paris, France B.S 7/79 Biology
University of California, Santa Barbara, U.S.A M.A 12/86 Pharmacology Doctorât d' État en Pharmacie, Université René Pharm D 10/85 Pharmaceutical Descartes Paris V, France Sciences
NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions below.
A. Personal Statement Seven years of experience in large pharmaceutical companies, ten years in entrepreneurial biotech industry and ten years in academia; Proven and extensive experience encompassing multiple functional disciplines in international and US business development, marketing, licensing, general management, new product planning, and intellectual property management. Track record leading successful negotiations and closing over 15 corporate alliances including in and out licensing generating substantial funding and revenue through an established network of senior executive in pharma and biotech. Highly competent in pharmaceutical product evaluations across range of therapeutic areas and thorough understanding of drug discovery, preclinical and clinical development from target discovery to product launches. Wrote new product development, marketing strategies and launched drugs in oncology, cardiovascular, metabolic diseases, CNS, inflammatory, anti- infective and vaccines. Demonstrated ability to recruit top talent and develop highly motivated, effective organizations. Raised over $90M in capital from venture sources, private, institutional investors, and public markets. At UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences, I created a new Master of Science in Drug Development & Product Management, and am teaching three courses. Initiated and developed multiple research collaboration for Health Sciences Faculty.
B. Positions and Honors Positions and Employment: 2018 - Present, Director, Strategic Academic Program Development Support Team, UC, San Diego 2018 - Present, Managing Director, Master in Science, Drug Development & Product Management UC, San Diego 2008 - Present, Health Sciences Associate Clinical Professor, N.S, University of California, San Diego 2008 - 2018, Director, Industrial Relations & Development University of California, San Diego 2003 - 2006, Executive Business Advisor, seven Biotech Companies, Hawaii Biotech, Inc., Attenuon LLC, 2001 - 2003 Chief Business Officer & Corporate Officer, SYRRX, San Diego CA 2001 - Vice President Business Development, Aurora Biosciences, San Diego, CA
PHS 398/2590 (Rev. 06/09) Page Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): 2000 - Co-Chief Executive Officer, Director and Co-Founder, GENEPROT, Inc., Proteomic Platform 1998 - 2000, Chief Executive Officer, President & Director, CEPTYR, Inc. Bothell, WA 1995 - 1998, Vice President, Marketing & Business Development & Corporate Officer, DEPOTECH, San Diego, CA 1993 – 1995, Director, New Product Planning, DURA Pharmaceuticals, San Diego, CA 1990 – 1993, Senior Product Manager, SYNTEX Pharmaceuticals, Palo Alto, CA 1989 - Product Manager, INTELLIGENETICS INC. Mountain View, CA 1988 - Associate Director, Medical-Marketing, STERLING-WINTHROP, Paris, France 1987 - Hospital Sales Representative, I.C.I. PHARMA, (AstraZeneca), Paris, France
C. Selected Peer-reviewed Publications Mol Pharmacol. 1987 May;31(5):500-5. Effect of pseudopterosin A on cell division, cell cycle progression, DNA, and protein synthesis in cultured sea urchin embryos. Ettouati WS, Jacobs RS.
D. Research Support None
PHS 398/2590 (Rev. 06/09) Page 2 Biographical Sketch Format Page CINDY EVANS NGUYEN, Esq. 10259 Rue Finisterre San Diego, CA 92131 858-204-4725 [email protected]
EDUCATION
UCSD Skaggs School of Pharmacy [La Jolla, CA] Pharm.D. Candidate, Class of 2019 Conference Facilitator & Teaching Assistant Pharmacy Law & Ethics 2016-2018 Honors in the following courses to date: Pharmacy Practice; Biopharmaceutics; Organic Chemistry; Biostatistics, Pharmacy Law & Ethics; Pharmacy Informatics; Drug Information; Pharmaceutical Chemistry; Dosage Forms & Drug Delivery; Gross Anatomy; Clinical Study Design; Pharmacokinetics; Human Disease; Neurology; Endocrinology, Reproduction & Metabolism; Microbiology; Pulmonary System; Principles of Pharmacology & Physiology; Pharmacoeconomics; Contemporary Topics Pharmacy; Microbio & Infectious Disease; Health Care Systems & Policy; Therapeutics
UCLA School of Law [Los Angeles, CA] J.D., Order of the Coif, May 2009 GPA: 3.79. Dean’s Scholarship 2006-2008. Journal of Law and Technology, Senior Articles Editor. Moot Court Honors Program. Asian Pacific Islander Law Student Association, Academic Chair.
Harvard University [Cambridge, MA] A.B., cum laude, Psychology 2006 GPA: 3.81. Harvard Faculty of Arts and Sciences Scholarship. Harvard Science Review, Associate Editor. Harvard Chinatown After-school Program, Counselor. Placed 1st in Vietnamese Essay Writing Competition, Harvard-Yenching Institute.
EXPERIENCE
Dawn Pharmacy, Pharmacy Intern and Clerk 9/1999 – present [San Diego, CA] Assist in execution and review of prescription dispensation and patient counseling; strategic management of pharmacy operations and healthcare compliance. Expedite process of prescription review, patient counseling, insurance billing, physician communications. Implemented and train regularly regarding HIPAA privacy compliance. Proactively translate for non-English speaking patients; counsel patients regarding medical/legal rights and medical coverage.
Intercept Pharmaceuticals, Attorney Consultant 4/2015 – 6/2015 [San Diego, CA] Consulting attorney in Intercept’s legal department, providing in-house corporate and intellectual property counsel with respect to a variety of corporate agreements, including manufacturing and supply, research and collaboration, grant and sponsorship, clinical trial, data transfer, material transfer, confidentiality, employment, consulting, and general service agreements. Responsible for all aspects of contract management, including drafting, reviewing and negotiating agreements from inception to execution, and ensuring compliance therewith.
Cytori Therapeutics, In-house Corporate Counsel 7/2011 – 3/2015 [San Diego, CA] In-house attorney reporting directly to General Counsel and CEO, working directly with Board of Directors on corporate governance matters. Provide legal counsel and guidance to officers or other managers on corporate legal matters. Draft, negotiate, interpret and analyze wide variety of domestic and international commercial agreements, including licensing, material transfer, clinical trial, research & development, loan financing, supply, distribution, manufacturing, commercial lease, professional services, confidentiality, and employment agreements. Provide legal advice in respect of healthcare, corporate and intellectual property matters to clients on governance, marketing, regulatory, employment and business issues across broad product portfolio and business. Counsel Company on regulatory, operational and contractual healthcare issues related to the marketing and promotion of products, including Food and Drug Administration advertising and promotional labeling issues.
Knobbe Martens Olson & Bear, Intellectual Property Attorney 9/2009 – 6/2011 [Irvine, CA] 5/2008 – 7/2008 Drafted intellectual property licensing, settlement, and assignment agreements. Managed intellectual property litigation. Drafted trademark and domain name complaints, motions for summary judgment, motions in limine, trial briefs. Provided compliance review and regulatory support for technology clients. Conducted and analyzed trademark search clearances for product branding and marketing. Advised regarding availability of trademarks for use and registration. Negotiated with CINDY EVANS NGUYEN
counsel regarding intellectual property disputes. Monitored and enforced clients’ IP rights throughout the U.S. and world. Spearheaded and successfully opposed summary judgment in an IP infringement case in the Central District of California.
United Nations Int’l Criminal Tribunal for Former Yugoslavia, Extern 8/2008 – 12/2008 [The Netherlands] Assisted trial attorneys in prosecution of persons responsible for violations of international humanitarian law. Prepared witnesses for in-court testimony. Conducted legal research regarding command responsibility.
Foley & Lardner, Intellectual Property Summer Associate 7/2008 – 8/2008 [San Diego, CA] Researched and drafted legal memoranda analyzing intellectual property and health care law. Participated in intellectual property litigation and patent prosecution.
Stradling Yocca Carlson & Rauth, Summer Associate 6/2007 – 8/2007 [Newport, CA] Drafted technology licensing agreements and privacy policies, participated in trademark and employment litigation, drafted summary judgment motion, organized document production.
PUBLICATIONS & PRESENTATIONS
• Susan Natland & Cindy Nguyen, Common US Marines slogan remains in the public domain, WORLD TRADEMARK REV., October 28, 2010. • Susan Natland & Cindy Nguyen, Use of identical mark is circumstantial evidence of dilution, WORLD TRADEMARK REV., July 19, 2010. • Cindy Nguyen, Associate, Knobbe, Martens, Olson & Bear, LLP, Guest Lecture at UCLA School of Law: Trademark Registration, March 4, 2010. • John Carson & Cindy Nguyen, In re Bose, 32(6) EUR. INTELL. PROP. REV., N48-49 (2010). • John Carson & Cindy Nguyen, USC v. Univ. South Carolina, 32(6) EUR. INTELL. PROP. REV., N49-50 (2010). • Cindy Nguyen, The Corporation: A Price Paid for the Psychopathic Pursuit of Profit and Power?, in THINKING ABOUT PSYCHOPATHS AND PSYCHOPATHY, 207, 207-21 (Ellsworth L. Fersch ed., 2006). • Cindy Nguyen, Mighty Mice and Super-Babies, 18 HARV. SCI. REV. 44, 44-7 (2004).
SKILLS, INTERESTS, AFFILIATIONS
• Admitted to State Bar of California (Cal Bar No. 267994) • Registered Patent Attorney with the U.S. Patent & Trademark Office (Registration No. 65,449) • Certification by Compliance Certification Board in Healthcare Compliance (2015) • ATHENA San Diego, Pinnacle Auction Committee Member • Association of Corporate Counsel, San Diego Chapter, 2011 – present • Orange County Asian American Bar Association, Board of Directors, 2009-2011 • Languages: fluent in Vietnamese, conversational in Spanish • Interests: traveling, Victorian literature, do-it-yourself projects
2 William M. Evans 10259 Rue Finisterre (760)-799-2670 San Diego, CA 92131 [email protected]
Experience Ionis Pharmaceuticals, Inc. Carlsbad, CA Director, Patents, April 2011 – present
Draft and prosecute patent applications relating to antisense compounds, nucleotide purification and synthesis, and siRNA compounds. Manage extensive world-wide patent portfolio. Negotiate and draft license agreements, MTAs, and CDAs. Manage post-grant proceedings in the US and Europe. Prepare Orange Book listings for FDA approved products. Analyze patent term extension for FDA approved products. Perform freedom to operate and patent landscape searches. Provide guidance on company policy related to electronic notebook maintenance and record keeping.
Knobbe Martens Olson & Bear LLP, San Diego, CA Associate, September 2009 – April 2011 Drafted and prosecuted patent applications directed to novel small molecules, polymers, nanotechnology, and pharmaceutical compositions. Performed freedom to operate and patentability searches and analysis.
University of California at San Diego, La Jolla, CA Teaching Assistant, September 2003 – August 2006 Supervised students working in organic synthesis laboratories. Performed weekly question and answer sessions and provided weekly lectures to groups of 40 to 350 students.
Irisys Research and Development, Inc., San Diego, CA Research Associate, May 2005 – April 2006 Manufactured drugs for clinical trial. Developed pharmaceutical formulations to meet FDA specifications. Performed analytical chemical testing to ensure drugs satisfied target specifications. Prepared standard operating procedures for cGMP manufacturing. Education University of San Diego School of Law, San Diego, CA Juris Doctor May 2009 GPA 3.48/4.33—Class Rank 60/327 Awards: CALI Award: Bioethics and the Law; Intellectual Property Seminar High Pass, Lawyering Skills I (Legal Research and Writing)
University of California at San Diego, La Jolla, CA Master of Science in Chemistry, January 2007 Honors: 2006 Outstanding Teaching Assistant Performance
University of California at San Diego, La Jolla, CA Bachelor of Science in Chemistry and Bachelor of Arts in History, June 2005 Honors: Provost’s Honors; Teaching Assistant Excellence Award Activities: 2000-2001 Men’s Crew
Affiliations California Bar No. 264,656 USPTO Registration No.: 64,800 Caroline Forrester Cell Phone: 619-547-9749. Email: [email protected]. Website: www.DrugInsight.org
EDUCATION • California Northstate University College of Pharmacy, Elk Grove, CA 5/2015 Doctor of Pharmacy (PharmD.), Magna cum Laude
• William Paterson University, Wayne, NJ 5/2007 Bachelor of Science in Chemistry
PROFESSIONAL EXPERIENCE Pharmacist Blogger/Freelance Writer Drug Insight.org (founder). An online company providing insightful articles and blogs on biologic and biosimilar drugs Selected blogs: • Are biosimilars a big deal anymore? (currently trending on LinkedIn #health) • Nucala approved for self-administration • Emgality approved for cluster headache treatment
Clinical Specialist 4/2019 to present MedImpact Healthcare Systems. Tempe, AZ • Provide drug information support. Research and provide clinical literature documentation to support prior authorization decisions • Review medication request guidelines for clinical appropriateness and operational efficiency and assist in the revision and creation of new or existing medication request guidelines as indicated
Drug Information Pharmacist 7/2016 to 3/2019 MedImpact Healthcare Systems. San Diego, CA • Analyze scientific drug data and develop timely drug and therapeutic class monographs containing accurate, relevant, non-biased clinical content, in support of the National Pharmacy & Therapeutics (P&T) Committee activities • Develop and present recommendations for drug formulary positioning, utilization management, and recommendations regarding client pharmacy benefit expenditures and utilization
Affiliate Faculty 1/2019 to present University of California, San Diego, Health Sciences. Skaggs School of Pharmacy. San Diego, CA • Conduct formal lectures for the Masters in Drug Development Program and precept pharmacy students
Freelance Writer 11/2018 to present OnCourse Learning (Relias). E-learning company based in Brookfield, WI PharmCon. E-learning company based in Myrtle Beach, SC • Identify and use credible health information sources to create Continuing Education manuscripts
PGY-1 Managed Care Pharmacy Resident (AMCP-ASHP Accredited) 7/2015 to 6/2016 OptumRx. Irvine, CA
INVITED LECTURES AND PRESENTATIONS UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences 4/2019 • Lecture Title: Pharmacy and Therapeutics Committees 101 • Course: DDPM-08 Principles of Marketing Strategy, Product Value, & Life Cycle Management Masters in Drug Development Class UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences 3/2019 • Lecture Title: Introduction to PBMs and Formulary Management • Course: DDPM-08 Principles of Marketing Strategy, Product Value, & Life Cycle Management Masters in Drug Development Class
USC School of Pharmacy, Los Angeles, CA 9/2015 • Lecture Title: Introduction to PBMs 101 • Course: USC Pharmacy School Managed Care Elective Course
PUBLICATIONS AND POSTERS • Woldemariam T, Malekakhlagh A, Bett C & Pearson D. “Evaluation of the Anti-Tumor Activity of Selected Herbs and Spices” J. Pharm. Sci. Pharmacol. 1, 296-303 (2014). https://doi.org/10.1166/jpsp.2014.1030. • Forrester C, Tran JN, Chung V. Impact of the Hepatitis C First Fill Consultation Program Over a One-Year Period. AMCP Annual conference, April 2016. • Forrester C, Lin A, Tso l, et al. Utilization Patterns of 2015 Updated Beers Criteria High Risk Medications in a Nationwide Medicare Population. Pharmacy Quality Alliance (PQA) Conference, January 2016. • Woldemariam T, Bett C, Malekakhlagh A. Clinical Application of Pharmacogenomics in Drug Therapy of Cardiovascular Disease (Chapter 7). In: Feng X, Hong-Guang X, eds. Applying Pharmacogenomics in Therapeutics, 181, January 2016. • Online Drug Monograph Publications: http://www.rxeconsult.com/profile/Caroline-Bett-PharmD-984/ • Blog articles: www.DrugInsight.org/blog
HONORS AND AWARDS • California Northstate University Pharm.D., Magna Cum Laude (5/2015) o Awarded for achievement of graduating GPA of 3.7 or higher • APhA-ASP California Northstate University Patient Counseling Competition Winner (1/2014) • American Pharmacists Association - Academy of Student Pharmacists • ABHP Student Leadership and Achievement Award (12/2014) • William Paterson University Excellence in Chemistry Award (5/2007) o Awarded by the Department of Chemistry for the top graduating Chemistry students • William Paterson University Dean’s List (2004 to 2006) • William Paterson University Full Presidential Scholarship (9/2004 to 5/2007) o Merit scholarship for academic excellence awarded towards full tuition and fees LICENSE • Registered Pharmacist - California State Board of Pharmacy License# 72845
PRECEPTING DUTIES • Developed a syllabus for a new 6-week Drug Information rotation for APPE 4th year UCSD pharmacy school students • Precepted MedImpact’s Managed Care Pharmacy Resident on the 6-week Drug Information Rotation • Precepted APPE students on rotation at OptumRx throughout residency • Attended residency and rotation fairs for UCSD, USC and California Northstate University Pharmacy Schools • Coordinated and hosted 100 students at the OptumRx Student Site visit • UCSD RxConnections student outreach event
SKILLS • Residency trained and experienced Managed Care Clinical Pharmacist with extensive experience in scientific data analysis, drug reviews, and presentation of utilization management recommendations to the Pharmacy and Therapeutics, Industry Relations and Formulary Strategy committees. Skilled in Drug Information, Prior Authorization, Drug Utilization and Formulary Strategy and Management, and Pharmacy and Therapeutics support. Subject matter expert on autoimmune biologics and biosimilars utilization and formulary management.
PROFESSIONAL AFFILIATIONS • Academy of Managed Care Pharmacy (AMCP) Katie Graham Lyons, Pharm.D., M.S. 1274 South Gilpin Street Denver, Colorado 80210 303.648.1978 [email protected]
Professional Experience
01/2015 - present President Trajet Consulting, Inc. Denver, Colorado http://www.trajetconsulting.com/
A Medical Affairs and Regulatory Consulting Firm offering a Path to a Solution-Oriented Approach. A sampling of offered services include:
Regulatory Affairs Services: General Regulatory Support; FDA Submission Content Creation; Compliance Guidance Development; Promotional Regulatory Assessment; Development and Delivery of Regulatory Training; Orphan drug designation and annual reports; Clinicaltrial.gov updates
Medical Operations Services: Chief Medical Officer Expertise; Medical Director Expertise; Launch Strategy; Standard Operating Procedure Development; Advisory Board Development and Execution; Pre-clinical and Clinical Study Support
Medical Communications Services: Tactics Development; Strategic Publication Plan Development and Management; Medical Writing; Scientific Meeting Presence; Medical Information Department; Advisory Board Support; Medical Review Capabilities Medical Liaison Training o Job Function, Regulatory Boundary, Presentation Skills, Therapeutic Content, Mission/Value, Roles/Responsibilities
08/2016 - present Senior Consultant The Medical Affairs Company, Inc.
Consultant providing promotional regulatory expertise Consultant providing medical communication expertise
03/2014 – 01/2015 Medical Affairs Director Merck.
Develop and maintain professional relationships with scientific leaders Act as content expert to deliver accurate, balanced and credible information in the Cardiovascular/Metabolic therapeutic area as it relates to Merck products and corresponding disease states Train speakers on the scientific content of slide decks Attend scientific and medical meetings Katie G. Lyons, Page 2
11/2010 – 03/2014 Director/Owner Medical Content Consulting Services.
Medical Affairs, Training and Promotional Regulatory Consulting Firm providing activities including:
Medical Affairs-based activities: Medical review and assessment for drug and device companies Training for new Medical Reviewers Training for Medical Liaison programs Medical Liaison program assessments and benchmarking Development/assessment of Medical Liaison Standard Operating Procedures Development of Medical materials both training and customer facing
Training-based activities: Promotional regulatory training for Medical Affairs; Commercial, Company Speakers and Third-Party vendors On-boarding training for promotional regulatory departments Development of continuing education content for pharmacists and pharmacy technicians Development of product standard language and resource documents Pharmacist education Advisory Board Member and collaboration for Pharm.D. course-work content
Promotional regulatory-based activities: Interim Senior Director Regulatory Affairs Promotional regulatory reviews, assessments and potential solutions Lectures on regulatory history and current regulatory environment Newsletter summaries for major regulatory meetings Desk Aid documents for promotional regulatory teams
01 – 10, 2010 Senior Consultant 11/2011- 06/2012 Opus Regulatory.
Provided regulatory review, assessment and strategic input for multiple pipeline and marketed products Provided assessments, reviews and approvals within the Medical Legal Board review based on interpretation of alignment with Code of Federal Regulation, FDA Guidelines, Product History, Company Policy, and Current Regulatory Environment for the legacy Schering Plough Oncology and Hepatitis franchises Managed 2253 Submissions
01/2007 – 08/2009 Senior Manager of Regulatory Promotions Global Regulatory Affairs. Amgen Inc.
Senior regulatory reviewer on internal and external materials in the Legal Regulatory Review Process o Assessments provided for Aranesp® Oncology, Vectibix®, denosumab oncology, denosumab bone and Corporate Account Pieces o Managed FDA submissions in accordance to FDA regulations Katie G. Lyons, Page 3
o Assisted with written communications to DDMAC (now OPDP) Managed the development of Product Reference Files Member providing strategic input during Global Regulatory, Label Working Group, Global Development, Product Safety, Product Clinical Strategy, Global Commercial Team, US Commercial Launch Team, US Brand Team and Product Regulatory Meetings Developed budget, metrics and resource allocation proposals Mentored assistant reviewers and contracting regulatory reviewers Supervised staff Participated in leadership, career management, selecting top talent, conflict management, negotiation, stress management and managing organizational change coursework
Training manager for the Regulatory Promotions Group (RPG) Initiated and drove collaboration with commercial to provide standardized baseline regulatory training across the business unit Developed and provided training to internal departments on relevant environmental changes including Enforcement Actions Developed and provided training on regulatory promotions to sales and scientific affairs new hires Updated and provided scientific interaction training to internal personnel Created and provided agency training for promotional regulatory boundaries Drove the creation of Conflict Management Training for the RPG Initiation and drove the development of standardized on-boarding for the regulatory promotion group o Core Reviewer Training; 30, 60, 90-day expectations; Team reference library; Desk aids; Standardized Review Template for Enforcement Actions Developed internal department rotations through regulatory promotions Initiated relationships with local schools Drove the creation of and acted as preceptor for Pharm.D. Clerkships rotations for pharmacy students from the University of Southern California and Western School of Pharmacy
03/2003 – 01/2007 Senior Manager Medical Communications Medical Affairs. Amgen Inc.
Medical Affairs representative and reviewer on internal and external promotional and scientific pieces ensuring all materials accurately represent scientific evidence and scientific related adherence to Code of Federal Regulations within the regulatory/legal review process Participation in process improvement task force Led the strategic collaborations between medical communications and marketing Strategic medical input for material development from concept to production o Led collaboration that decreased developmental costs for field materials o Selected areas of focus or therapy and product knowledge for training of medical and commercial personnel Katie G. Lyons, Page 4
o Developed and provided Sales and Medical Affairs training o Co-leader in re-structuring new hires Sales Training o Provided medical input in Strategic Brand Planning Strategic point and manager for medical communication activities supporting new market evaluations Provided scientific expertise, consultation for materials used at advisory boards, speaker training and consultant meetings o Developed and provided scientific content at National Advisory Board Meetings Managed development of resources and trainings for Regional Medical Liaisons Led strategic global publication plan o Led development and maintenance of objective and project driven plan o Responsible for planning, initiation and coordination of publications o Led the development of core references o Coordinated abstract, poster and manuscript development o Review of publications prior to submission Support internal Medical Affairs as liaison with external thought leaders Managed Medical Affairs presence at Scientific Congress o Coordination of scientific booth content o Managed scientific activity presence o Developed and provided scientific and promotional booth training Provided competitive intelligence and scientific support Revision of Medical Information Letter Participation in Product Working Group, Medical Affairs, Brand Planning, Promotional and Medical Strategic Plan of Action Meetings Mentor for Medical Communication new hires and contractors Supervisor for administrative staff Provided educational presentations to health care professionals Training manager o Developed and implemented standardized new hire training o Developed and provided training at regional sales meetings o Preceptor for Pharm.D. Externship Clerkship rotation
08/2001 – 03/2003 Clinical Science Manager, Pain and Arthritis and Urology Global Medical Affairs. Pharmacia.
02/2001 – 08/2001 Medical Science Liaison, Neurology and Women’s Health Global Medical Affairs. Wyeth Pharmaceuticals.
08/2000 – 02/2001 Medical Science Liaison, Infectious Disease Medical Affairs. Dura Pharmaceuticals. Katie G. Lyons, Page 5
Academic Experience
01/2019 – present Affiliate Faculty; Course Co-Chair: Marketing Strategy, Product Management & Life Cycle Product Management and Student Advisor University of California San Diego School of Pharmacy. MS in Drug Development & Product Management. La Jolla, California.
06/2009 - present Invited Lecturer University of Southern California Masters in Regulatory Program. Los Angeles, California Developed and Provide Promotional Regulatory Lecture in Regulation of Drugs and Biological Products Coursework Developed and Provide Hands-on Workshop on Promotional Regulatory Review in Regulation of Drugs and Biological Products Coursework
01/2015 – present Student Credit Portfolio Challenge Evaluator University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. Distance Degree Program. Aurora, Colorado
02/2010 – 02/2017 Invited Lecturer University of California San Diego School of Pharmacy. La Jolla, California Developed and Provide Pharmaceutical Considerations in Phase III Research, Labeling Submission and Promotion in Drug Development Coursework Pharmacy Student Mentor for those interested in careers within the pharmaceutical industry
01/2016-01/2018 Facilitator: Inter-professional Education and Development University of Colorado Medical Campus: Inter-professional Education Development. Aurora, Colorado
01/2012 – 03/2014 Part-Time Instructor University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. Aurora, Colorado Non-traditional Pharm.D. Program Part-Time Instructor Collaborated in revamping Seminars in Pharmaceutical Care Coursework
02/2011 - 01/2012 Lecturer Rx School. AMN Healthcare Education Services. Develop and provide continuing pharmacist education lectures Advisory Board Member
01/2008 – 08/2009 Clinical Preceptor University of Southern California School of Pharmacy. Los Angeles, California
08/2008 – 08/2009 Preceptor / Clinical Assistant Professor of Pharmacy Practice Western University of Health Sciences College of Pharmacy. Pomona, California Katie G. Lyons, Page 6
08/1999 – 08/2000 Graduate Research Assistant: Bench Research University of Illinois at Chicago College of Health and Human Sciences. Chicago, Illinois
08/1999 -08/2000 Contract Faculty University of Missouri at Kansas City School of Pharmacy. Kansas City, Missouri
07/1998 – 07/1999 Clinical Assistant Professor University of Missouri at Kansas City School of Pharmacy. Kansas City, Missouri
07/1997 – 06/1998 Clinical Instructor University of North Carolina School of Pharmacy. Chapel Hill, North Carolina
Scientific Education
08/1999 – 08/2002 Masters of Science in Kinesiology, Exercise Physiology University of Illinois at Chicago. Chicago, Illinois
07/1997 – 06/1998 Pediatric Pharmacotherapy Fellow University of North Carolina School of Pharmacy. Chapel Hill, North Carolina
07/1996 – 06/1997 Pharmacy Practice Residency Children's Hospital Medical Center, Cincinnati, Ohio
09/1990 – 05/1996 Doctor of Pharmacy Drake University, Des Moines, Iowa
Research Publications
Scott CS, Graham, KM. Taste Comparison of Common Medications Used in the Cystic Fibrosis Population. Journal of Pediatric Pharmacy Practice. 1999; 4 (3): 139-145.
Scott CS, Retsch-Bogart GZ, Kustra RP, Graham KM, Glasscock BJ, Smith PC. The Pharmacokinetics of ibuprofen suspension, chewable tablets, and tablets in children with cystic fibrosis. Journal of Pediatrics. 1999; 13 (4): 340-345.
Graham KM, Larson L. Student Perceptions of Alternative Therapies. Journal of Pharmacy Teaching. 1998; 6(3): 53-66. Abstracts
Scott CS, Graham, KM. Taste Comparison of Common Medications Used in the Cystic Fibrosis Population. Pediatric Pharmacy Advocacy Group Annual Meeting, Kiawah Island, South Carolina. 1998. Scott CS, Retsch-Bogart GZ, Kustra RP, Graham KM, Glasscock BJ, Smith PC. Pharmacokinetics of Ibuprofen Suspension, Chewable Tablets, and Tablets in Children with Cystic Fibrosis. Pediatric Pharmacy Advocacy Group Annual Meeting, Kiawah Island, South Carolina. 1998. Katie G. Lyons, Page 7
Scott CS, Retsch-Bogart GZ, Kustra RP, Graham KM, Glasscock BJ, Smith PC. Pharmacokinetics of Ibuprofen Suspension, Chewable Tablets, and Tablets in Children with Cystic Fibrosis. North American Annual Cystic Fibrosis Meeting, Montreal, Canada. 1998.
Scott CS, Retsch-Bogart GZ, Kustra RP, Graham KM, Wong JQ, Smith PC. Pharmacokinetics of Ibuprofen Suspension in Young Children with Cystic Fibrosis. North American Cystic Fibrosis Annual Meeting, Nashville, Tennessee. 1997.
Selected Articles
“A Pharmacist’s Role in Treatment Options for Autism”. Pharmacy Choice. Available at: http://www.pharmacychoice.com/education/diseases/autism.cfm?autism=autism
“A Pharmacist’s Role in End of Life Care” Chain Drug Review. February 28, 2011.
“Protease Inhibitors” Therapeutic Concepts. Children’s Hospital Medical Center, Cincinnati, Ohio. 1997.
Articles Featured In Davis M, Worrell J. The Fellowship Experience: Postdoctoral Fellowships in Pharmacy Can Be A Valuable Tool in Building A Career. Carolina Pharmacy. Spring 2007: 6-9.
Selected Invited Presentations Since 2010
Moderator: Understand Recent Enforcement Trends and the Impact on Medical Affairs Processes. CBI Medical Affairs Advancement Forum. January 20-21, 2016.
Moderator: Medical Science Liaison Breakout Educational Stream. CBI Medical Affairs Advancement Forum. January 20-21, 2016.
“Promotional Regulatory: What is it? And Why is it important?” Regulation of Drugs and Biological Products Coursework. University of Southern California Masters in Regulatory Coursework. 2009-2017
“Pharmaceutical Considerations in Phase III Research and Labeling Submission” Drug Development Coursework. University of California San Diego School of Pharmacy. 2010- 2017
“Communicating During the Pre-Approval Stages: A Medical Perspective” Drug Information Association Marketing Pharmaceuticals Meeting. 2014.
“How to Spot ‘Bad Ads’: Drug Regulation Past, Present and Future”. A Continuing Education Program for Pharmacists and Pharmacy Technicians. Rx School. 2011
Current Organizations
Drug Information Association The Food and Drug Law Institute Regulatory Affairs Professional Society
Current Licensures
Pharmacist License Ohio # 03-3-21699 Pharmacist License Colorado # 0018693 OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018)
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Joseph D. Ma eRA COMMONS USER NAME (credential, e.g., agency login): joema1 POSITION TITLE: Professor, Division of Clinical Pharmacy EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY
University of California, Irvine B.S. 06/1998 Biology University of California, San Francisco Pharm.D. 06/2002 Pharmacy Bassett Healthcare, Cooperstown, NY Fellowship 06/2004 Clinical Pharmacology
A. Personal Statement I have a background in clinical pharmacology, with training and expertise in drug metabolism, pharmacokinetics, and pain management. My current clinical practice is at an outpatient pain and palliative care consultation service. Under a collaborative practice protocol, I see patients, have prescribing privileges and based on my assessment of the patient, I am able to start, stop, and/or modify medication therapy. Over the past several years, I have served as a research mentor to pharmacy students, medical students, pharmacy residents, medical residents, and to post-doctoral fellows. Since 2013, I have directed a pharmacy student summer research program whereby approximately 30 students participate in a full time, 10-week summer research program whereby each student is assigned a mentor and specific research project. As PI or co-investigator on university-, private sector-, and CDC-funded grants, I have the expertise, experience, training, and motivation necessary to successfully carry out the research for our proposed program, and my expertise and experience have prepared me to successfully perform the proposed work for this collaborative project.
B. Positions and Honors Positions and Employment 2002- Licensed Pharmacist, California State Board of Pharmacy, RPH 53980 2002-2004 Postdoctoral Fellow, Bassett Healthcare, Cooperstown, NY 2004-2006 Clinical Trial Specialist, Amgen, Inc., Thousand Oaks, CA 2004-2007 Staff Pharmacist, Pavilions Pharmacy, Westlake, CA 2006-2007 Senior Research Associate, Amgen, Inc., Thousand Oaks, CA 2007-2013 Assistant Professor of Clinical Pharmacy, University of California (UC) San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) 2007-2010 Attending Pharmacist, UC San Diego, Health Care Free Clinic, San Diego, CA 2010- Pain and Palliative Care Pharmacist, Moores Cancer Center, UC San Diego 2013-2017 Associate Professor of Clinical Pharmacy, UC San Diego, SSPPS 2017- Professor, Division of Clinical Pharmacy, UC San Diego, SSPPS
Other Experience and Professional Memberships 2002–2013 Member, American Society for Clinical Pharmacology and Therapeutics 2007– Member, American College of Clinical Pharmacology 2007- Member, American College of Clinical Pharmacy 2008-2009 Meeting Co-chair, 2009 American College of Clinical Pharmacology Annual Meeting 2012-2013 Meeting Co-chair, 2013 American College of Clinical Pharmacology Annual Meeting
Honors and Awards 1997 National Institute on Drug Abuse (NIDA) Intramural Research Training Award, NIH 1998 National Institute on Drug Abuse (NIDA) Intramural Research Training Award, NIH 2002 Finalist, UCSF School of Pharmacy Bowl of Hygeia Award 2008 National Center of Leadership in Academic Medicine, UCSD School of Medicine 2008 Excellence in Teaching Award, UCSD SSPPS Class of 2009 2013 Excellence in Teaching Award, UCSD SSPPS Class of 2014 2015 Fellow, American College of Clinical Pharmacology 2017 Excellence in Teaching Award, UCSD SSPPS Class of 2017
C. Contribution to Science
1. Phenotyping involves the use of a probe drug to quantify in vivo, real-time, drug-metabolizing enzyme activity. I continue to pursue an area of research in optimizing methods for quantification of cytochrome P450 (CYP) activity. Such methods included single-point, sparse sampling, and/or limited sampling models to evaluate CYP activity in order to simplify study design and decrease study-related costs and time. My research has shown that some of these methods lack adequate validation, are highly biased, and susceptible to center specificity, thus leading to erroneous conclusions. We have also determined novel limited sampling models, with the utilization of appropriate validation methods, for estimation of CYP3A and CYP2C19 activities. The implication of our research is that future phenotyping studies using such methods must be adequately validated in order to accurately determine in vivo, real-time, drug-metabolizing enzyme activity. I served as the primary investigator in all of these studies. a. Nguyen AN, Hoffman JT, Tsunoda SM, I-J Jang, Ma JD. (2012). Evaluation of intravenous midazolam limited sampling models to determine area under the concentration time curve during cytochrome P450 3A baseline, inhibition, and induction or activation. International Journal of Clinical Pharmacology and Therapeutics; 50(7):468-475. b. Masters JC, Harano DM, Greenberg HE, Tsunoda SM, Jang I-J, Ma JD. (2015). Limited sampling strategy of partial area-under-the-concentration-time-curves to estimate midazolam systemic clearance for cytochrome P450 3A phenotyping. Therapeutic Drug Monitoring; 37(1):84-89. c. Chang AT, Bertino JS Jr, Nafziger AN, Kashuba ADM, Turpault S, Lewis LD, Ma JD. (2016) S- warfarin limited sampling models to estimate area under the concentration versus time curve for cytochrome P450 2C9 baseline activity and following induction. Therapeutic Drug Monitoring; 38(3):383-387.
2. Detection of parent drug and/or metabolite concentrations via urine drug testing is used in clinical practice to confirm prescribed and/or illicit drug use. Limitations exist on the use of urine as the specimen for analysis such as tampering and significant intra- and inter-individual variability of drug concentration measurements. These publications identified what patient-specific factors contributed to urine drug concentration variability as well as quantified the extent of such variability in a pain population. I served as the primary investigator or co-investigator in all of these studies. a. Yee DA, Atayee RS, Best BM, Ma JD. (2014). Observations on the urine metabolic profile of codeine in pain patients. Journal of Analytical Toxicology; 38(2):86-91. b. Bordson SJ, Atayee RS, Ma JD, Best BM. (2014). Tricyclic antidepressants: is your patient taking them? Observations on adherence and unreported use using provider-reported medication lists and urine drug testing. Pain Medicine; 15(3):355-363. c. Yee DA, Hughes MM, Guo AY, Barakat NH, Tse SA, Ma JD, Best BM, Atayee RS. (2014). Observation of improved adherence with frequent urine drug testing in pain patients. Journal of Opioid Management; 10(2): 111-118. d. Barakat NH, Atayee RS, Best BM, Ma JD. (2014). Urinary hydrocodone and metabolite distributions in pain patients. Journal of Analytical Toxicology; 38(7):404-409.
3. Pharmacogenomics has potential clinical application in maximizing drug efficacy and/or minimizing drug toxicity. A significant barrier to implementing pharmacogenomics is health care professionals’ lack of knowledge on pharmacogenomics. For 3 years, I served as co-Investigator for the development of a shared pharmacogenomics curriculum for health care professionals. The program was designed to increase awareness about current knowledge of the validity of pharmacogenomic tests and their potential clinical implications. I was involved in creating the educational curriculum (9 educational modules), reviewing and editing the educational modules, determining website content, designing case vignettes for interactive learning, and providing continuing education lectures at local and national professional meetings (14 invited presentations). a. Lee KC, Ma JD, Hudmon KS, Kuo GM. (2012). A train-the-trainer approach to a shared pharmacogenomics curriculum for US colleges and schools of pharmacy. American Journal of Pharmaceutical Education; 76(10): Article 193. b. Kuo GM, Lee KC, Ma JD. Implementation and outcomes of a live continuing education program on pharmacogenomics. (2013). Pharmacogenomics; 14(8):885-895. c. Lee KC, Hudmon KS, Ma JD, Kuo GM. (2015). Evaluation of a shared pharmacogenomics curriculum for pharmacy students. Pharmacogenomics; 16(4):315-322.
Complete List of Published Work in MyBibliography: https://www.ncbi.nlm.nih.gov/myncbi/browse/collection/46319048/?sort=date&direction=ascending
Research Support Ongoing Research Support – None
Completed Research Support 1U38GD000070-01 Kuo (PI) 09/2008-09/2011 Pharmacogenomics education program: Bridging the gap between science and practice The goal of this program was to develop a shared pharmacogenomics curriculum for health care professionals and students. Role: Co-Investigator
Millennium Research Institute Best (PI) 06/2011-07/2013 Urinary Excretion Pharmacokinetics of Pain Medications The goal of this program was to examine patient factors in contributing to pain medication inter- and intra- individual pharmacokinetic variability. Role: Co-Investigator
UC San Diego, Academic Geriatric Resource Center (AGRC) 06/2011-06/2012 Pharmacy Student-Initiated Education Program The goal of this program was to develop an educational curriculum related to older adult health and nutritional needs. Role: Principal Investigator
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Jeremiah Momper eRA COMMONS USER NAME (credential, e.g., agency login): JEREMIAHMOMPER POSITION TITLE: Assistant Professor of Clinical Pharmacy EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY
University of Pittsburgh, Pittsburgh, PA PharmD 04/2006 Pharmacy
University of Pittsburgh, Pittsburgh, PA PhD 12/2011 Pharmaceutical Sciences
A. Personal Statement
I am a Pharmacologist within the Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego. The primary goal of my research is to identify factors that regulate the pharmacokinetics and pharmacodynamics of drugs in order to optimize drug therapy and drug development. I have a broad background in clinical pharmacology and pharmacokinetics and received additional training in drug development as a Commissioner’s Fellow at the U.S. Food and Drug Administration. I also have technical expertise in the quantitation of drugs and metabolites in biological fluids using liquid chromatography-tandem mass spectrometry (LC-MS/MS). I direct the UCSD Drug Development Program, a core lab that provides screening tools for in vitro ADME and in vivo pharmacokinetics. I am also a protocol pharmacologist in the International Maternal International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) network and am actively involved in trials evaluating antiretroviral drugs in pregnant women. As part of this project I will serve as a pharmacology consultant for a phase one trial for an IL23 antibody in alcoholic liver disease. I have the appropriate training, experience, and scientific environment to carry out this role in the project.
B. Positions and Honors
2006 – 2011 Clinical Pharmacist, Drug Use and Disease Management Program University of Pittsburgh Medical Center, Pittsburgh, PA 2011 – 2013 Commissioner’s Fellow, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 2013 – 06/2019 Assistant Professor of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, CA 07/2019 – Present Associate Professor of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, CA
C. Contributions to Science
Maternal and Pediatric Clinical Pharmacology
My research has focused on understanding sources of variability in drug disposition and response in the atypical patient, and using this information to improve drug therapy. In pregnancy, several important physiological changes occur that alter pharmacokinetics and pharmacodynamics. In therapeutic areas where treatment is necessary during pregnancy, such as HIV, it is critical to account for these differences in order to optimally dose medications. Under-dosing poses risks such as poor control of disease and associated symptoms, resistance, and transmission of infections to the fetus, whereas over-dosing is associated with maternal and fetal toxicity. In children, including premature neonates and those with rare diseases, growth and maturation cause a dynamic setting characterized by extensive interindividual variability in drug disposition and response. A major ongoing research focus is the application of novel clinical pharmacology tools to improve scientific decision-making, dose selection, and drug development in these vulnerable populations.
Momper JD, Best BM, Wang J, Capparelli EV, et al. Elvitegravir/Cobicistat Pharmacokinetics in Pregnant and Postpartum Women with HIV. AIDS. 2018 Nov 13;32(17):2507-2516. PMC6209536
Momper JD, Capparelli EV, Wade KC, et al. Population Pharmacokinetics of Fluconazole in Premature Infants Less than 750 Grams Birth Weight. Antimicrob Agents Chemother. 2016 Jul 11. PMC4997840
Momper JD, Wagner JA. Therapeutic drug monitoring as a component of personalized medicine: Applications in pediatric drug development. Clin Pharmacol Ther. 2014 Feb;95(2):138-40.
Edginton AN, Shah B, Sevestre M, Momper JD. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of 6 years. Clin Pharmacokinet. 2013 Aug;52(8):693-703.
Regulation of Drug-Metabolizing Enzymes and Transporters in Infection and Inflammation
The functional expression and activity of drug metabolizing enzymes and transporters are principal determinants of drug exposure, which directly relates to desired and adverse pharmacologic effects. My work has generated experimental and clinical evidence demonstrating the role of uremic toxins and cytokines in modifying OAT1-mediated anionic secretion in the kidney. These findings have been used to optimize the dosing of antiviral nucleotide analogs for the treatment of polyomavirus infections in renal transplant recipients and have broad implications for drug therapy in kidney disease.
Momper JD, Nigam SK. Developmental regulation of kidney and liver SLC and ABC drug transporters and drug metabolizing enzymes: the role of remote organ communication. Expert Opin Drug Metab Toxicol. 2018 Jun 4:1-10. PMC6277044
Momper JD, Zhao Y, Shapiro R, Schonder KS, Yao G, Randhawa P, Venkataramanan R. Pharmacokinetics of low-dose cidofovir in kidney transplant recipients with BK virus infection. Transpl Infect Dis. 2013 Feb;15(1):34-41. PMC3654813
Momper JD, Venkataramanan R, Nolin TD. Nonrenal Drug Clearance in CKD: Searching for the Path Less Traveled. Adv Chronic Kidney Dis. 2010;17(5):384-391.
Momper JD, Zhang S, Randhawa PS, Shapiro R, Schonder KS, Venkataramanan R. Determination of cidofovir in human plasma after low dose drug administration using high-performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2010;53(4):1015-21. PMC3654809
Pre-Clinical Drug Development for Neglected Tropical Diseases and Medical Countermeasures
Neglected tropical diseases (NTDs) affect over a billion people in developing countries. Medical countermeasures (MCMs) encompass drugs that may be used for biodefense against biological, chemical, or radiological bioweapons. Both NTDs and MCMs receive limited interest from the pharmaceutical industry necessitating academic drug discovery and development, including lead identification and optimization. My research has focused on pre-clinical drug development for NTDs and MCMs in a collaborative fashion with PIs engaged in drug discovery. Specifically, my laboratory performs in vivo and in vitro drug metabolism and pharmacokinetic studies to identify potential compound liabilities and guide structural modifications or other development strategies to optimize lead compounds from a pharmacokinetic-pharmacodynamic perspective.
Bachovchin KA, Sharma A, Bag S, Klug DM, Schneider KM, Singh B, Jalani HB, Buskes M, Mehta N, Tanghe S, Momper JD, Sciotti RJ, Rodriguez A, Mensa-Wilmot K, Pollastri MP, Ferrins L. Improvement of Aqueous Solubility of Lapatinib-derived Analogs: Identification of a Quinolinimine as a Lead for Human African Trypanosomiasis Drug Development. J Med Chem. 2019 Jan 24;62(2):665-687. PMC6556231
Yoo E, Stokes BH, de Jong H, Vanaerschot M, Kumar T, Lawrence N, Njoroge M, Garcia A, Van der Westhuyzen R, Momper JD, Ng CL, Fidock DA, Bogyo M. Defining the Determinants of Specificity of Plasmodium Proteasome Inhibitors. J Am Chem Soc. 2018 Aug 29. PMC6407133
Mesci P, Macia A, Moore SM, Shiryaev SA, Pinto A, Huang CT, Tejwani L, Fernandes IR, Suarez NA, Kolar MJ, Montefusco S, Rosenberg SC, Herai RH, Cugola FR, Russo FB, Sheets N, Saghatelian A, Shresta S, Momper JD, Siqueira-Neto JL, Corbett KD, Beltrão-Braga PCB, Terskikh AV, Muotri AR. Blocking Zika virus vertical transmission. Sci Rep. 2018 Jan 19;8(1):1218. PMC5775359
Post-exposure treatment with the oxime RS194B rapidly reactivates and reverses advanced symptoms of lethal inhaled paraoxon in macaques. Rosenberg YJ, Wang J, Ooms T, Rajendran N, Mao L, Jiang X, Lees J, Urban L, Momper JD, Sepulveda Y, Shyong YJ, Taylor P. Toxicol Lett. 2018 Sep 1;293:229-234. PMC5943181
Complete List of Published Work in MyBibliography: https://www.ncbi.nlm.nih.gov/myncbi/jeremiah.momper.1/bibliography/public/
D. Additional Information: Research Support and/or Scholastic Performance
ACTIVE
NIH UM1AI068632 (PI: Nachman) 09/01/18 – 11/30/19 National Institute of Allergy and Infectious Diseases (NIAID) LOC-IMPAACT LEADERSHIP GROUP The goal of the project and IMPAACT's mission is to decrease incident HIV and HIV-associated infections including mother-to-child transmission (MTCT) and to decrease mortality/morbidity due to HIV and HIV- associated infections and co-morbidities among infants, children, adolescents, and pregnant/postpartum women worldwide Role: Consortium PI (Prime: Johns Hopkins University)
NIH 1R01HD096798 (PI: Wachman) 07/01/18 – 06/30/23 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use The goal of the project is to characterize the safety, pharmacokinetics, and efficacy of extended-release naltrexone during pregnancy Role: Consortium PI (Prime: Boston University)
NIH R01HD095547 (PI: Bradley) 04/01/18 – 06/30/22 Eunice Kennedy Shriver National Institute of Child Health and Human Development Longitudinal Assessment of Beta-Iactam Antibiotic Exposure in Critically Ill Children with Sepsis in the PICU to Predict Dosing Requirements The goal of this project is to present new antibiotic dosing guidelines for children with sepsis in the PICU, with the potential to optimize daily dosing to save lives and decrease sepsis-mediated morbidity. Role: Co-Investigator
NIH #1R01HD095857-01 (PI: Buekens) 09/01/2018 - 05/31/2023 National Institute of Allergy and Infectious Diseases (NIAID) Short-course Benznidazole Treatment to Reduce Trypanosoma cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiority Randomized Controlled Trial The goal of this project is to conduct a clinical trial to evaluate if a 30 day/150mg course benznidazole treatment is non-inferior to a 60 day/300mg course. Role: Co-investigator
NIH U54 #1U54HD090259 (PI: Tremoulet) 09/20/2016 – 06/30/21 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Developmental Pharmacology for Inflammatory and Infectious Diseases The goal of this project is to advance the knowledge of clinical and basic pharmacology, pharmacokinetics (PK) and clinical therapeutics of antimicrobial and anti-inflammatory agents in infants, children and adolescents. Role: Co-Investigator
IN-US-380-5492 (PI: Momper) 8/21/19 – 09/30/20 Gilead Sciences, Inc. Efficacy, safety, and pharmacokinetics of bictegravir/emtricitabine/tenofovir alafenamide in combination with darunavir with cobicistat or ritonavir in treatment experienced patients with HIV The overall goal of this project is to evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) in treatment experienced patients. Role: Principal Investigator
HDTRA11910006 (PI: Taylor) 9/1/18 – 8/31/23 Defense Threat Reduction Agency (DTRA) CNS Active, Orally Bioavailable, Zwitterionic Oxime Antidotes to Organophosphates The goal of the project is to advance zwitterionic oximes as superior antidotes to nerve agent organophosphates used in chemical warfare and associated terrorism. Role: Co-Investigator
20192106 (PI: Tsunoda) 5/30/19 – 12/31/23 Veloxis Pharmaceuticals Inc. Assessment of the Intestinal CYP3A Contribution to Drug Interactions with Evarsus XR Using Grapefruit Juice The goal of the project is to evaluate the magnitude of grapefruit juice on tacrolimus pharmacokinetic parameters in stable kidney transplant patients taking Envarus XR. Role: Co-Investigator
1R21AI142452 (Caffrey) 07/1/19 – 06/30/21 0.6 Cal Months NIH/NIAID Translational development of cysteine protease inhibitors to treat hookworm disease The goal of this project is to test a number of pre-clinically advanced inhibitors of cysteine proteases as a novel drug therapy to treat hookworm infection. Role: Co-Investigator
COMPLETED
NIH R21 AI127505-01 (PI: Gerwick/Lage de Siqueira Neto) 12/01/2016 – 11/30/19 National Institute of Allergy and Infectious Diseases (NIAID) Development of Gallinamide A Analogs to Treat Trypanosoma cruzi (Chagas' Disease) The goal is to generate a late stage preclinical lead for the treatment of Chagas’ Disease from "cruzain", a unique protease of a marine cyanobacterium. Role: Co-investigator
NIH 1UH2TR002084 (PI: Ekins) 09/01/17-08/31/19 National Institute of Neurological Disorders and Stroke Repurposing pyronaridine as a treatment for Chagas disease The goal of this project is to determine the minimum effective dose of pyronaridine in an acute model of Chagas disease and efficacy in the chronic phase while also assessing potential for combination therapy Role: Co-Investigator CHANTAL A. REED (LACKEY), Ph.D. 14018 Crest Way (760) 845-6842 Del Mar, CA 92014 [email protected] PROFESSIONAL EXPERIENCE BRAIN HZ CONSULTING, INC. Del Mar, CA. Vice President (3/08 – present) Consulting services in Pharmaceutical Development and Analytical Sciences. Technical writing for internal reports to support product development, and regulatory submissions, including NDA, MAA, IND, DSUR and IMPD. Registration and special stability, specification justification, excipient compatibility, residual solvents, elemental impurities, analytical method validation, analytical method development, method transfer, photostability, packaging studies, preservative effectiveness testing, and other analytical and pharmaceutical development reports. Stability tracking and trending for drug product and drug substance. Data auditing, data analysis, cell-based assay development, study design, and literature reviews. Biologics and small molecules, various routes of administration. IONIS PHARMACEUTICALS, Carlsbad, CA. Senior Scientist (8/03 – 4/05) in Pharmaceutical Development. Pharmaceutical R & D in drug delivery and product quality for antisense oligonucleotides. Formulation research to qualify new dosage forms appropriate for specific therapeutic indications and routes of administration. Focused on novel (liposomal and polymeric) dosage forms, aseptically prepared parenteral solutions and nasal sprays. Designed and led animal studies to ascertain the effectiveness of novel formulations. IONIS PHARMACEUTICALS, Carlsbad, CA. Senior Scientist in Antisense Lead Identification (9/01 – 8/03). Validation of lead oligonucleotides. Optimization of transfection conditions in new and difficult cell types, including primary cells, investigating cell-type specific parameters which affect the efficiency of in vitro transfection, and Effectively communicated protocols to corporate partners. Hired, trained and managed a research associate to validate targets for partners. UNIVERSITY OF WASHINGTON, Seattle, WA. Ph.D. Student (9/96 – 8/01) Complexation of synthetic, pH-responsive polymers with proteins to enhance endosomal release of targeted biomolecules and increase therapeutic efficacy. Assessment of membrane disruptive activity, quantitation of uptake, analysis of intracellular localization, cassette mutagenesis to create bifunctional proteins, and derivatization and conjugation of polymers and proteins. UNIVERSITY OF CALIFORNIA, LOS ANGELES, Los Angeles, CA. Lab Technician in the Department of Microbiology, Immunology and Molecular Genetics (Summers 1994 – 1996). Genetic engineering, gene sequencing, gene mapping, PCR analysis, complementation testing of mutants, determination of frequency of mutation. HARVARD UNIVERSITY, Cambridge, MA. Lab Technician in the Division of Applied Sciences (Part-time 1994 – 1996). Constructed and tested hip pads and floor panels to reduce incidence of hip fracture in falls. Aided in design of simple tests to assess risk for a sideways fall.
EDUCATION
Ph.D., BIOENGINEERING. 9/96 – 8/01. UNIVERSITY OF WASHINGTON, Seattle, WA. pH-Responsive Polymer-Protein Conjugates for Control of Intracellular Trafficking of Biomolecular Therapeutics. B.A. ENGINEERING SCIENCES. 9/92 – 6/96. HARVARD UNIVERSITY, Cambridge, MA. Cum Laude. AWARDS AND HONORS 2000 NSF IGERT Fellowship Award from the University of Washington Center for Nanotechnology (support for one academic year). 2000 American Society of Gene Therapy merit based travel grant. 1998 Controlled Release Society-Cygnus Graduate Student Award for Outstanding Work in Drug Delivery. 1997 University Initiative Fund Graduate Fellowship from the University of Washington Center for Nanotechnology (support for two academic years).
PUBLICATIONS AND PATENTS Hoffman, A. S., Stayton, P., Press, O. W., Murthy, N., Lackey Reed, C., Crum, L. A., Mourad, P. D., Porter, T. M., and Tirrell, D., (2004) Enhanced transport using membrane disruptive agents. United States Patent 8,846,106. Hoffman, A. S., Stayton, P. S., El-Sayed, M. E. H., Murthy, N. Bulmus, V., Lackey, C., and Cheung, C. (2007) Design of “smart” nano-scale delivery systems for biomolecular therapeutics. Journal of Biomedical Nanotechnology, 3(3), 213-7. Reed, C. A., Peralta, E. R., Wenrich, L. M., Wong, C. A., Bennett, C. F., Freier, S., and Lollo, B. (2005) Transfection protocol for antisense oligonucleotides affects uniformity of transfection in cell culture and efficiency of mRNA target reduction. Oligonucleotides, 15(1), 12-22. Stayton, P. S., El-Sayed, M. E. H., Murthy, N., Bulmus, V., Lackey, C., Cheung, C., and Hoffman, A. S. (2005) ‘Smart’ delivery systems for biomolecular therapeutics. Orthodontics and Cranofacial Research. 8(3), 219-25. Hoffman, A. S., Stayton, P., Press, O. W., Tirrell, D., Murthy, N., Lackey, C., Crum, L. A., Mourad, P. D., and Porter, T. M. (2004) Enhanced transport using membrane disruptive agents. United States Patent 6,835,393. Liang, Y., Osborne, M. C., Monia, B. P., Bhanot, S., Gaarde, W. A., Reed, C., She, P., Jetton, T. L., and Demarest, K. T. (2003) Reduction in glucagon receptor expression by an antisense oligonucleotide ameliorates diabetic syndrome in db/db mice. Diabetes. 53(2), 410-7. Lackey, C. A., Press, O. W., Hoffman, A. S., and Stayton, P. S. (2002) A Biomimetic pH-Responsive Polymer Directs Endosomal Release and Intracellular Delivery of an Endocytosed Antibody Complex. Bioconjugate Chemistry, 13(5), 996-1001. Hoffman A. S., Stayton P. S., Bulmus V., Chen G., Chen J., Cheung C., Chilkoti A., Ding Z., Dong L., Fong R., Lackey C. A., Long C. J., Miura M., Morris J. E., Murthy N., Nabeshima Y., Park T. G., Press O. W., Shimoboji T., Shoemaker S., Yang H. J., Monji N., Nowinski R. C., Cole C. A., Priest J. H., Harris J. M. (2000) Really Smart Bioconjugates Of Smart Polymers And Receptor Proteins. Journal of Biomedical Materials Research. 52(4), 577-86. Stayton, P.S., Hoffman, A.S., Murthy, N., Lackey, C., Cheung, C., Tan, P., Klumb, L.A., Chilkoti, A., Wilbur, F.S., and Press, O.W. (2000) Molecular engineering of proteins and polymers for targeting and intracellular delivery of therapeutics. Journal of Controlled Release. 65(1-2), 203-20. Lackey, C. A., Murthy, N., Press, O. W., Tirrell, D. A., Hoffman, A. S., and Stayton, P. S. (1999) Hemolytic Activity of pH-responsive Polymer-Streptavidin Bioconjugates. Bioconjugate Chemistry. 10, 401-5. Slupska, M.M., King, A.G., Lu, L.I., Lin, R.H., Mao, E.F., Lackey, C.A., Chiang, J.H., Baikalov, C., and Miller, J.H. (1998) Examination of the role of DNA polymerase proofreading in the mutator effect of miscoding tRNAs. Journal of Bacteriology. 180(21), 5712-7. ORAL PRESENTATIONS (poster presentations not listed) Lackey, C. A., Press, O. W., Hoffman, A. S., and Stayton, P. S. (2001) pH-Sensitive Polymer-Protein Complexes for Control of Intracellular Trafficking of Biomolecular Therapeutics. American Chemical Society National Meeting. San Diego, CA. April 1-5. Lackey, C. A., Press, O. W., Hoffman, A. S., and Stayton, P. S. (2000) Enhancement of Cell Transfection Efficiency by a Biomimetic Membrane-Disruptive Polymer in a Model Nonviral, Targeted Delivery System. Biomedical Engineering Society Annual Meeting. Seattle, WA. October 12-14. Lackey, C. A., Press, O. W., Hoffman, A. S., and Stayton, P. S. (2000) Enhancement of Cell Transfection Efficiency by a Biomimetic Membrane-Disruptive Polymer in a Model Nonviral, Targeted Delivery System. American Society of Gene Therapy National Meeting. Denver, CO. May 31-June 4. Lackey, C. A., Murthy, N., Stayton, P. S., Press, O. W., Hoffman, A. S. and Tirrell, D. A. (1998) Stimuli- Responsive Biomolecular Conjugates: Controlled Membrane Disruption. Controlled Release Society International Symposium. Las Vegas, NE. June 21-24.
LABORATORY SKILLS
DNA/RNA: Real-time RT-PCR, RNA isolation from cells and tissues, site-directed mutagenesis, plasmid subcloning, PCR, plasmid isolation, agarose gel electrophoresis, Northern blotting, gel extraction, DNA sequencing, bacterial transformation, competent cell preparation. PROTEIN: Bacterial expression and purification of recombinant proteins (including streptavidin and ricin A chain), SDS-PAGE, Western blotting, polymer-protein conjugation, derivatization with small molecules (fluorescent probes, biotin), hemolysis assay. CELL CULTURE: Lipid transfection of oligonucleotides into cells, isolation and culture of primary cells from human blood, electroporation, fluorescence and DIC microscopy, flow cytometry, confocal microscopy, plasmid transfection, radioactive protein synthesis assay, cellular uptake quantitation, maintenance of several cell lines including primary cells. ANIMAL WORK: Animal care and handling, subcutaneous administration of drug, necropsy. DRUG PRODUCT: Aseptic manufacturing of drug product under GLP conditions
TEACHING EXPERIENCE UNIVERSITY OF CALIFORNIA, SAN DIEGO, San Diego CA. Skaggs School of Pharmacy and Pharmaceutical Sciences Course Chair for SPPS 225, “Dosage Forms and Drug Delivery Systems” (Winter’07 – present) Health Sciences Assistant Clinical Professor, Non-Salaried (6/07 – present) UNIVERSITY OF PHOENIX, San Diego, CA. Faculty for Research and Evaluation I and II, “Statistics for Business.” (7/06 – 9/06) SAN DIEGO CITY COLLEGE, San Diego, CA. Adjunct Faculty in Biological Sciences for Biology 107, “Biology for Non-Majors.” (1/05 – 12/05) HARVARD UNIVERSITY, Cambridge, MA. Course Assistant for Biological Sciences 2, “Organismic and Evolutionary Biology.”(9/95 – 12/95)
ADDITIONAL SKILLS cGMP and GLP trained Bilingual (French/English)
VANDE CASTEELE, Niels
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Vande Casteele, Niels eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Medicine, University of California San Diego, La Jolla, CA, USA EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY
Dept. of Pharmaceutical and Pharmacological Pharmaceutical Sciences, University of Leuven - KU Leuven, B.S. 06/07 Sciences Belgium
Dept. of Pharmaceutical and Pharmacological Drug Development, Sciences, University of Leuven - KU Leuven, M.S. 06/09 Major Subject Belgium. Pharmacy Institute of Medical Sciences, University of Aberdeen, Scotland.
Dept. of Pharmaceutical and Pharmacological Pharmaceutical Ph.D. 05/13 Sciences, University of Leuven - KU Leuven, Sciences Belgium
Clinical Pharmacology Dept. of Medicine, Division of Gastroenterology, Postdoctoral 10/16 and Outcomes Inflammatory Bowel Disease Center, University of Fellow Research California San Diego
A. Personal Statement I am a clinical pharmacologist with nine years of experience in public-private research in the field of chronic inflammatory diseases and drug development, therapeutic drug and immunogenicity monitoring of biologics, including bioanalytical method development, population pharmacokinetics (PK), pharmacodynamics (PD) & pharmacometrics, disease-specific outcome measures and biomarkers. In addition, I have five years of experience in the scientific and operational aspects of clinical research and clinical trials with a strong interest in precision medicine and trial design. The opportunity to transform human health through scientific research has motivated me to pursue an international, meaningful and flourishing academic career. My outstanding track record of productivity and unique expertise as clinical pharmacologist have allowed me to secure funding both from competitive international grant agencies, as well as from pharmaceutical industry. As an Assistant Professor of Medicine in the Division of Gastroenterology, I will further grow that independence by initiating projects that will lead to successful results, publications and subsequent grant funding, to become an independent investigator and a cornerstone in the Department of Medicine at UC San Diego. With the support of Robarts Clinical Trials, I have taken the lead in building a global Translational Research Consortium including eight world-renowned IBD centers, including UC San Diego, for conducting state-of-the- art precision medicine research including multicenter real-world evidence generation and early drug development in gastrointestinal diseases. Besides longitudinal real-world data collection of patient-level data, the Consortium has the capabilities to perform ‘omics analysis in blood, tissue and fecal samples and conduct bioinformatics for data integration and ‘omics data analysis.
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VANDE CASTEELE, Niels
B. Positions and Honors Positions 2008 Undergraduate Student, University of Aberdeen, Aberdeen, Scotland 2008 – 2009 Pharmacist intern, Apotheek Van Meerbeek – Picard, Sterrebeek, Belgium 2009 – 2013 PhD Student, University of Leuven - KU Leuven, Leuven, Belgium 2012 Graduate Student, University of Amsterdam, Amsterdam, The Netherlands 2013 – 2016 Postdoctoral Fellow, University of Leuven - KU Leuven, Leuven, Belgium 2013 – 2016 Academic Research Fellow, Robarts Clinical Trials, San Diego, CA 2013 – 2016 Postdoctoral Fellow, UCSD, La Jolla, CA 2016 – 2017 Associate Project Scientist, UCSD, La Jolla, CA 2013 – Present Consultant, Pharmaceutical and Life Science Industry 2017 – Present Assistant Professor of Medicine, Division of Gastroenterology, UC San Diego, La Jolla, CA Honors 07/2011 Travel Grant to attend the 10th ULLA Summer School of Pharmacy, Parma, Italy 02/2012 Poster of Distinction, European Crohn’s and Colitis Organisation (ECCO) meeting, Barcelona, Spain 02/2012 Best abstract, ECCO meeting, Barcelona, Spain 05/2012–07/2012 Research Grant, Academische Stichting, Leuven, Belgium 05/2012 Horizon Pharma Student Abstract Prize, Digestive Diseases Week (DDW) meeting, San Diego, CA 11/2012 Travel Grant to attend the Globalization Pharmaceutics Education Network meeting, Melbourne, Australia 02/2013 Honorary Fellowship from the Belgian American Educational Foundation, Belgium 03/2013 Incentive Grant from the Flemish Association of Gastroenterology, Belgium 10/2013 Travel Grant to attend the United European Gastroenterology Week (UEGW) meeting, Berlin, Germany 10/2013 Top Abstract Prize at the UEGW meeting, Berlin, Germany 12/2013 Travel Grant to attend the Advances in Inflammatory Bowel Disease meeting, Hollywood, FL 05/2014 Poster of Distinction, DDW meeting, Chicago, IL 05/2015 Young Investigator Outstanding Poster Prize, DDW meeting, Washington, DC 06/2016 Poster of Distinction, DDW meeting, San Diego, CA 05/2017 Poster of Distinction, DDW meeting, Chicago, IL 01/2018 Lloyd Mayer Career Development Award, CCC meeting, Las Vegas, NV 06/2018 Research Scholar Award, DDW meeting, Washington, DC 03/2019 Top-10 Digital Oral Presentations, ECCO meeting, Copenhagen, Denmark C. Contributions to Science 1. Clinical pharmacokinetics and pharmacodynamics of biologics I have expert knowledge in the field of clinical pharmacology as it pertains to biologics used in the treatment of inflammatory diseases. My contributions have led to a better understanding of the PK and PD of these complex molecules. Moreover, retrospective and prospective studies have shown the value of performing therapeutic drug monitoring (TDM) to optimize therapy. Specifically, I was the principle investigator of the first randomized controlled trial investigating personalized dosing of infliximab based on TDM in IBD patients (TAXIT trial). This landmark trial was conducted in 263 IBD patients and showed that TDM of infliximab can lead to a more efficient use of drug. Another important implication of this study is that causality was shown between drug exposure and response to therapy. My expertise is sought after by peers, academic and industrial collaborators, and various medical associations as demonstrated by my contribution to clinical guidelines on the value of TDM in IBD in the United States and Australia, as well as my contribution to various review articles and editorials. - Vande Casteele N, Baert F, Bian S, et al. Subcutaneous Absorption Contributes to Observed Interindividual Variability in Adalimumab Serum Concentrations in Crohn's Disease: A Prospective Multicentre Study. J Crohns Colitis 2019 [Epub ahead of print] - Vande Casteele N, Jeyarajah J, Jairath V, et al. Infliximab Exposure-Response Relationship and Thresholds Associated with Endoscopic Healing in Patients with Ulcerative Colitis. Clin Gastroenterol Hepatol 2018 [Epub ahead of print]
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VANDE CASTEELE, Niels
- Hemperly A, Sandborn WJ, Vande Casteele N. Clinical pharmacology in adult and pediatric inflammatory bowel disease. Inflamm Bowel Dis 2018;24(12):2527-2542. - Vande Casteele N, Oyamada J, Shimizu C, et al. Infliximab pharmacokinetics are influenced by intravenous immunoglobulin administration in patients with Kawasaki disease. Clin Pharmacokinet 2018;57(12):1593-1601 - Vande Casteele N, Feagan BG, Vermeire S, et al. Exposure-response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease. Aliment Pharmacol Ther 2018;47(2):229-237. - Mitrev N, Vande Casteele N, Seow CH, et al. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther 2017;46(11-12):1037-1053 - Vande Casteele N, Herfarth H, Katz J, et al. American Gastroenterological Association technical review on the role of therapeutic drug monitoring in the management of inflammatory bowel diseases. Gastroenterology 2017;153(3):835-857.e6 - Vande Casteele N, Mould DR, Coarse J, et al. Accounting for pharmacokinetic variability of certolizumab pegol in patients with Crohn’s disease. Clin Pharmacokinet 2017;56(12):1513-1523 - Vande Casteele N & Khanna R Therapeutic drug monitoring of golimumab in the treatment of ulcerative colitis. Pharm Res 2017;34(8):1556-1563 - Hindryckx P, Novak G, Vande Casteele N, et al. Review article: dose optimisation of infliximab for acute severe ulcerative colitis. Aliment Pharmacol Ther 2017;77(4):363-377 - Ben-Horin S, Vande Casteele N, Schreiber S, et al. Biosimilars in inflammatory bowel disease: facts and fears of extrapolation. Clin Gastroenterol Hepatol 2016;14(12):1685-1696 - Cleynen I, Van Moerkercke W, Billiet T, Vandecandelaere P, Vande Casteele N, et al. Characteristics of anti-TNF-associated skin lesions in inflammatory bowel disease patients: a cohort study. Ann Int Med 2016;164(1):10-22 - Papamichael K, Van Stappen T, Jairath V, Gecse K, Khanna R, D'Haens G, Vermeire S, Gils A, Feagan BG, Levesque BG, Vande Casteele N. Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Aliment Pharmacol Ther 2015;42(10):1158-69 - Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015;148(7):1320-9.e3 - Arias M, Vande Casteele N, Vermeire S, et al. A panel to predict long-term outcome of infliximab therapy for patients with ulcerative colitis. Clin Gastroenterol Hepatol 2015;13(3):531-8 - Vande Casteele N & Gils A. Pharmacokinetics of anti-TNF monoclonal antibodies in inflammatory bowel disease: adding value to current practice. J Clin Pharmacol 2015;55 Suppl 3:S39-50 - Vande Casteele N, Khanna R, Levesque BG, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut 2015;64(10):1539-45 - Papamichael K, Gils A, Rutgeerts PJ, Levesque BG, Vermeire S, Sandborn WJ, Vande Casteele N. The role for therapeutic drug monitoring during induction therapy with TNF antagonists in IBD: evolution in the definition and management of primary non response. Inflamm Bowel Dis 2015;21(1):182-97 - Baert F, Vande Casteele N, Tops S, et al. Cohort study: prior response to infliximab and early serum drug concentrations predict effect of adalimumab in ulcerative colitis. Aliment Pharmacol Ther 2014;40(11- 12):1324-32 - Vande Casteele N, Ballet V, Van Assche G, et al. Early serial trough and antidrug antibody level measurements predict clinical outcome of infliximab and adalimumab treatment. Gut 2012;61(2):321 2. Immunogenicity of biologics By using a multidisciplinary approach combining know-how and expertise from the field of molecular biology, pharmacology, immunology and medicine, I could show that not all antibodies generated against a biologic have the same impact on PK and clinical outcomes as some anti-drug antibodies are transient and others are persistent. This concept has now been replicated for other drugs and in various disease indications. This work was a stepping stone for identifying an association between human leukocyte antigen (HLA) type and risk for immunogenicity. Characterizing the immunogenicity profile of a drug in a population is critical from an efficacy perspective, but also from a safety perspective as we have shown that presence of these antibodies is associated with acute severe infusion reactions. - Van Stappen T, Vande Casteele N, Van Assche G, et al. Clinical relevance of detecting anti-infliximab antibodies with a drug-tolerant assay: post hoc analysis of the TAXIT trial. Gut 2018;67(5):818-826
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VANDE CASTEELE, Niels
- Hindryckx P, Novak G, Vande Casteele N, et al. Incidence, prevention and management of anti-drug antibodies against therapeutic antibodies in inflammatory bowel disease: a practical overview. Drugs 2017;77(4):363-377 - Billiet T, Vande Casteele N, Van Stappen T, et al. Immunogenicity to infliximab is associated with HLA- DRB1. Gut 2015;64(8):1344-5 - Baert F, Kondragunta V, Lockton S, Vande Casteele N, et al. Antibodies to adalimumab are associated with future inflammation in Crohn's patients receiving maintenance adalimumab therapy: a post hoc analysis of the Karmiris trial. Gut 2016;65(7):1126-31 - Vande Casteele N, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol 2013;108(6):962-71 - Vande Casteele N, Breynaert C, Vermeire S, et al. Incidence of acute severe infusion reactions to infliximab depends on definition used rather than assay. Aliment Pharmacol Ther 2011;34(3):401-403 3. Bioanalytical assay development and validation My analytical skills and expertise have allowed me to develop, optimize and validate robust assays that allow to conduct state-of-the-art translational research, including histological assessment of disease activity, immunohistochemistry, proteomics, transcriptomics, flow cytometry, etc. Some of these assays (for TDM) were compared towards other established tests in various studies and were licensed to global diagnostics companies, making them commercially available globally. Creative thinking also led to the exploration of novel (pre)analytical methods such as sampling via dried blood spot to facilitate sample collection, development of a cell-based assay that allows to distinguishing neutralizing from non-neutralizing anti-drug antibodies and development of an acid dissociation competitive ligand binding assay, which allows to measure anti-drug antibodies in serum, even in the presence of drug. I was the principle investigator of two prospective multicenter trials to compare 1) the variation in quantification of T-cell responses in peripheral blood mononuclear cells using flow cytometry and 2) histology, transcriptomics and immunohistochemistry outcomes across biopsy samples from different location in Crohn’s disease patients. - Novak G, Stevens T, Van Viegen T, …, Vande Casteele N. Evaluation of optimal biopsy location for assessment of histological activity, transcriptomic and immunohistochemical analyses in patients with active Crohn's disease. Aliment Pharmacol Ther 2019 [Epub ahead of print] - Vande Casteele N, Wildenberg ME. Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis. J Immunol Methods 2018 [Epub ahead of print] - Wildenberg ME, Duijvestein M, Westera L, van Viegen T, Buskens CJ, van der Bilt JDW, Stitt L, Jairath V, Feagan BG, Vande Casteele N. Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies. J Immunol Methods 2018;459:50-54 - Westera L, van Viegen T, Jeyarajah J, Azad A, Bilsborough J, van den Brink GR, Cremer J, Danese S, D'Haens G, Eckmann L, Faubion W, Filice M, Korf H, McGovern D, Panes J, Salas A, Sandborn WJ, Silverberg MS, Smith MI, Vermeire S, Vetrano S, Shackelton LM, Stitt L, Jairath V, Levesque BG, Spencer DM, Feagan BG, Vande Casteele N. Centrally determined standardization of flow cytometry methods reduces interlaboratory variation in a prospective multicenter study. Clin Transl Gastroenterol 2017;8(11):e126 - Vande Casteele N. Assays for measurement of TNF antagonists in practice. Frontline Gastroenterol 2017;8(4):236-242. - Van Stappen T, Bollen L, Vande Casteele N, et al. Rapid test for infliximab drug concentration allows immediate dose adaptation. Clin Transl Gastroenterol 2016;7(12):e206 - Van Stappen T, Billiet T, Vande Casteele N, et al. An optimized anti-infliximab bridging enzyme-linked immunosorbent assay for harmonization of anti-infliximab antibody titers in patients with inflammatory bowel diseases. Inflamm Bowel Dis 2015;21(9):2172-7 - Gils A*, Vande Casteele N*, Poppe R, et al. Development of a universal anti-adalimumab antibody standard for interlaboratory harmonization. Ther Drug Monit 2014;36(5):669-73 - Vande Casteele N, Brecx S, Ferrante M, et al. Letter: dry blood spots for anti-TNF treatment monitoring in IBD. Aliment Pharmacol Ther 2013;37(10):1024-5 - Vande Casteele N*, Buurman D*, Sturkenboom M, et al. Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays. Aliment Pharmacol Ther 2012;36(8):765-71 *Both authors contributed equally An overview of my citations and citations indices can be found through my Google Scholar Profile: https://scholar.google.com/citations?user=nYTgUm4AAAAJ&hl=en&oi=ao
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VANDE CASTEELE, Niels
D. Additional Information: Research Support and/or Scholastic Performance 1. Current research support Investigator-initiated Research, Takeda Vande Casteele (PI) 07/18–11/19 Title: Development and Validation of A Technique for the Quantification of Denaturated and Degraded Drug in Colonic Tissue Samples from Inflammatory Bowel Disease Patients Treated with Vedolizumab The goal of this study is to develop and validate a multiple reaction monitoring-mass spectrometry (MRM-MS) technique for the quantitative proteomic analyses for the detection and quantification of vedolizumab in tissue. Research Scholar Award, American Gastroenterology Association Vande Casteele (PI) 07/18–08/21 Title: Identifying Optimal Thresholds & Personalized Dosing Regimens of Inflximab to Maximize Endoscopic Remission Rates in Patients with Ulcerative Colitis The goal of this study is to interrogate the correlation between endoscopic outcomes and systemic (serum) and local (tissue) infliximab exposure to delineate thresholds that are associated with endoscopic healing. Investigator-initiated Research, Takeda Vande Casteele (Co-I) 07/17–12/19 Title: Interrogating mechanisms of action underlying clinical efficacy of vedolizumab for inflammatory bowel diseases The goal of this study is to elucidate the mechanism of action of vedolizumab by confirming target engagement and doing state-of-the-art translational research and biomarker development in mouse models and in clinical samples. 2. Past research support Pilot Grant, Altman Clinical Translational Research Institute (UCSD) Vande Casteele (PI) 04/18–03/19 Title: Quantification of Denaturated and Degraded Drug in Intestinal Tissue Samples from Inflammatory Bowel Disease Patients Treated with Vedolizumab The goal of this study is to develop and validate a novel technique to quantitatively measure denaturated and possibly degraded vedolizumab in intestinal mucosal tissue, serum and stool samples. Career Development Award, Crohn’s and Colitis Foundation Vande Casteele (PI) 01/18–6/18 Title: Identifying Optimal Thresholds & Personalized Dosing Regimens of Infliximab to Maximize Endoscopic Remission Rates in Patients with Ulcerative Colitis The goal of this study is to describe inter-individual variability in drug and target disposition in patients that will allow for a personalized dosing approach to increase the likelihood of patients responding favorably to therapy. Postdoctoral Fellowship, Fund for Scientific Research (FWO) Vande Casteele (PI) 10/13–09/16 Title: Translating therapeutic drug monitoring of biopharmaceuticals into individualised care of inflammatory bowel disease patients through pharmacometric modelling and pharmacoeconomic evaluation. The goal of this study was to develop and validate advanced pharmacokinetic and pharmacodynamic models about biologics used in the treatment of inflammatory bowel diseases. Junior Mobility (JuMo) Grant, University of Leuven – KU Leuven Vande Casteele (PI) 2014–2015 Title: Translating therapeutic drug monitoring of biopharmaceuticals into individualized care of inflammatory bowel disease patients through pharmacometric modelling. The goal of this study was to interrogate the value of therapeutic drug monitoring of biologics on large datasets collected through clinical practice and clinical trials. International Mobility Grant, Fund for Scientific Research (FWO) Vande Casteele (PI) 2013–2014 Title: Development of a toolbox to personalize anti-TNF treatment in IBD patients by doing functional testing, patient stratification and profound pharmacokinetic and -dynamic analyses of retro- and prospective clinical studies. The goal of this study was to define specific thresholds of drug concentration thresholds of various biologics that correspond to clinically important outcomes.
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Farrah Wong, Pharm.D. San Diego, CA ▪ (626) 823-9909 ▪ [email protected]
EXPERIENCE
OptumRx Irvine, California Senior Director, Commercial Formulary Contracting Strategy, Industry Relations June 2018 - Present . Lead the formulary management and contracting strategies for OptumRx commercial formularies for over 25 million lives . Oversee the contracting strategies for over 100 therapeutic classes in both pharmacy and medical benefit drugs, with rebates exceeding $8 billion annually . Lead the development and implementation of effective formulary strategies that focus on clinically sound and affordability measures . Collaborate with clients to support custom formulary and trend management options for over 15 million lives . Leveraging analytics and clinical tools, investigate potential drug trend drivers and opportunities for lowering total plan costs . Collaborate with cross functional teams to assess drug trends and implement strategies to mitigate drug spend . Preceptor for residents and pharmacy students in the OptumRx Clerkship and Residency programs
OptumRx (formerly Prescription Solutions) Irvine, California Senior Director, Pipeline and Drug Surveillance, Clinical Services February 2016- Present Manager, Pipeline and Drug Surveillance, Clinical Services 2011 – January 2016 . Spearheaded the OptumRx First Movers process to mitigate potential high costs and utilization of high impact pipeline drugs for over 65 million member lives. Key accomplishments included: - Successfully reduced costs for targeted drugs by up to 86% - Leveraged intelligence from the Pipeline program and analytical tools to model out potential clinically appropriate, cost-effective formulary management programs - Proactively evaluated and strategized formulary management options with clients and contracting team prior to drug approval (e.g., Harvoni, Entresto, Orkambi) - Full integration of the OptumRx First Movers process with various departments and clients - Seamless execution with cross functional groups to ensure management strategies for first movers were implemented and operationalized expeditiously and accurately - Thorough review and assessment of first movers prior to drug approval; expedited P&T review of first movers upon approval . Oversee the OptumRx Drug Pipeline program to provide pharmaceutical intelligence to various clients in the Commercial, Medicare Part D, and Medicaid markets by providing: budgetary impact analyses for high impact pipeline drugs; evaluation of pipeline drugs anticipated to have appreciable impact on therapeutic management, utilization, and financial patterns; drug pipeline meetings; and pipeline trend reports . Direct the drug pipeline utilization management process to leverage pipeline information in plan benefit designs and management options . Collaborate with Medicare clients to support the CMS Bid process with the inclusion of pipeline drugs and their projected utilization and budgetary impact
Farrah Wong, Pharm.D. Page 1 of 5 . Lead the Biosimilars and Generics Monitoring program to provide insight, trend forecasts, and utilization management strategies for first-time biosimilars and generics to maximize affordability . Oversee the Price Surveillance program to proactively monitor for drug cost fluctuations allowing for prompt action to protect clients from undo financial exposure . Manage the Drug Safety clinical program to meet NCQA/URAC accreditation and regulatory requirements . Oversee the development and distribution of clinical publications and talking points to provide timely pharmaceutical information to numerous segments within Optum and to clients . Designed and launched the long-term drug shortage notification process to be in compliance with CMS regulatory requirements . Preceptor for residents and pharmacy students in the OptumRx Clerkship and Residency programs
Prescription Solutions Irvine, California Clinical Pharmacist, Clinical Services 2008 – 2011 . Identified, researched, analyzed, and presented key drugs in development that may provide clinical impact to existing treatment paradigms on a bimonthly basis to physicians and pharmacists . Collaborated with Analytics to estimate the budgetary impact of developmental drugs for Medicare and commercial health plans . Supported the development, enhancement, and maintenance of the Generics Strategy program . Developed and implemented the Drug Safety Program to meet regulatory compliance; initiatives included member and provider mailings, drug recall alerts, and talking points . Evaluated and delivered oral presentations of drug and class reviews to the P&T Committee . Supported the clinical development and maintenance of utilization management programs, including prior authorization, step therapy, edits, and quantity limits . Expanded and led the Clinical News Summary program to disseminate time-sensitive articles to physicians, pharmacists, and nurses capturing topics with significant clinical impact . Managed the Prescription Solutions Rx News® clinical publication, which highlighted current clinical topics and pipeline trends . Preceptor for residents and pharmacy students in the OptumRx Clerkship and Residency programs . Member of the Prescription Solutions Residency Committee
Prescription Solutions Irvine, California Clinical Pharmacist, Formulary Management 2006 – 2008 . Performed Part D formulary analyses, including drug tiering, compliance with Centers for Medicare and Medicaid Services requirements, and market share projections . Researched, evaluated, and analyzed developmental drugs that may impact prescribing trends . Collaborated with the Analytics team to estimate the budgetary impact developmental drugs may have on Medicare and commercial health plans upon approval . Delivered ACPE-accredited drug pipeline presentations to physicians, pharmacists, and pharmacy technicians . Prepared and presented comprehensive drug monographs, including single drug reviews, class reviews, and new drug formulation reviews to the P&T Committee . Composed and e-published the Pipeline Forecast newsletter and first-time generics to clients and healthcare professionals . Restructured the pipeline review process . Researched and responded to drug information requests
Farrah Wong, Pharm.D. Page 2 of 5
Little Company of Mary Hospital Torrance, California Clinical Pharmacist 2005 – 2007 . Performed pharmacokinetics for aminoglycoside and vancomycin therapy, Coumadin® monitoring and dosing, parenteral nutrition monitoring and adjustments, and renal dosing . Assessed and reviewed appropriateness of antibiotic usages during Infectious Disease rounds with physicians and nursing staff . Participated in drug use evaluations, adverse drug reaction reporting, and I.V. to P.O. switch program . Supervised and trained pharmacy technicians and intern pharmacists . Provided pharmacological knowledge and recommendations to healthcare professionals, including physicians, nurses, and nutritionists . Reconciled patient home medications to ensure uninterrupted therapy . Processed and verified prescriptions in the inpatient and outpatient pharmacies . Compounded prescriptions . Compared economic and health safety issues between Lantus® and Levemir® for formulary consideration
Sav-On Drugs Monterey Park, California Intern Pharmacist 2005 . Processed and filled prescriptions . Counseled patients about medications and potential side effects . Recommended over-the-counter products . Verified with third party billing companies for insurance billing . Interacted with physicians’ offices for prescription refills
Kaiser Permanente Los Angeles, California Intern Pharmacist 2002 – 2004 . Performed drug interventions at various hospital units including the intensive care, cardiac care, and telemetry units . Dosed antibiotics and suggested alternative medications for patients . Prepared intravenous and chemotherapeutic solutions . Revised the inpatient adult narcotics/sedation protocol
CONFERENCE PRESENTATIONS & WEBINARS
“What’s Trending for Pharmacy?” Orlando, Florida sPCMA Business Forum. Presentation. March 2019
“What’s Trending for Pharmacy in 2018?” Las Vegas, Nevada Optum Client Forum. Presentation. August 2018
“Drug Pipeline: What’s Next and What to Expect” Washington, DC Optum Client Forum. Presentation. August 2017
“Are You Keeping Pace with the Dynamics of Biosimilars and the Drug Pipeline?” Orlando, Florida PBMI Drug Benefit Conference. Presentation. March 2017
Farrah Wong, Pharm.D. Page 3 of 5 “Managing High Impact Pipeline Drugs” Anaheim, California Optum Client Forum. Presentation. August 2016
“Big Savings for Biosimilars? Discounts in mirror may be smaller than they appear” OptumRx. Webinar. July 2016
“High Impact Pipeline” Washington, DC PCMA Policy Forum. Presentation. April 2016
“Pipeline Data, Modeling and Clinical Information – Evolving Payer Considerations” Orlando, Florida sPCMA Business Forum. Presentation. February 2016
“How Payers Use Pipeline Data and Analysis to Make Decisions ” Orlando, Florida sPCMA Business Forum. Presentation. March 2015
“Trends in Specialty Pharmacy” Specialty Pharmacy Times. Webinar. August 2011
EDUCATION
University of Southern California, School of Pharmacy Los Angeles, California Doctor of Pharmacy May 2005
University of California, Los Angeles Los Angeles, California Bachelor of Science in Physiological Science December 2000
LICENSURE
California Board of Pharmacy Registered Pharmacist . License: 57382 . Expiration Date: 11/30/2020
HONORS
UnitedHealth Group Irvine, California Living the Values “Better Together” Award 2015
University of Southern California, School of Pharmacy Los Angeles, California Project of the Year Award - Kids’ Day 2003
Howard Hughes Medical Institute Pasadena, California Research Fellowship at California Institute of Technology Summer 1999, Summer 2000
University of California, Irvine Irvine, California Dean’s List Fall 1998, Winter 1999
Farrah Wong, Pharm.D. Page 4 of 5
PROFESSIONAL AFFILIATIONS
Academy of Managed Care Pharmacy 2008 – Present Member Contributor, AMCP/ISPOR/NPC CER Collaborative Focus Group 2011
REFERENCES
Available Upon Request
Farrah Wong, Pharm.D. Page 5 of 5 OMB No. 0925-0001 and 0925-0002 (Rev. 11/16 Approved Through 10/31/2018)
BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Yam, Felix K. eRA COMMONS USER NAME (credential, e.g., agency login): FELIX_YAM
POSITION TITLE: Associate Clinical Professor of Pharmacy
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY
University of Rhode Island College of Pharmacy, Pharm.D. 05/2004 Pharmacy Kingston, RI University of Kentucky, Lexington, KY Residency 06/2005 Pharmacy Practice University of Kentucky, Lexington, KY Residency 06/2006 Primary Care Pharmacy Management Cedars-Sinai Medical Center, Los Angeles, CA Residency 08/2007 and Leadership MAS University of California, San Diego, CA Clinical 12/2012 Clinical Research Research University of California, San Diego, CA Fellowship 08/2012 Pharmacotherapy
A. Personal Statement
My area of practice and research in cardiovascular diseases and heart failure provide me the necessary tools to successfully serve as co-principal investigator for the proposed research project. I have a broad background in clinical pharmacy with specific training and expertise in cardiovascular diseases and clinical research. My clinical expertise includes working in a multidisciplinary heart failure clinic and practicing as a mid-level provider to improve adherence and utilization of guideline-directed medical therapies. I have formal training in clinical research and have participated in multiple clinical trials involved in evaluating novel therapies and technologies for heart failure. My role in these clinical trials included recruitment of study participants, evaluation of patients during clinical visits, and investigational drug services. In addition, I have experience in conducting several observational retrospective cohort studies in the area of heart failure. As a result of these experiences, I am aware of the leadership and project management skills needed to provide appropriate study oversight. The current research project builds logically within my area of practice and research aimed at improving outcomes for patients with heart failure.
Yam, FK. Lew, T., Eraly, SA., Hsiang, Wl., Hirsch, JD., Devor, MJ. Changes in medication regimen complexity and the risk for 90-day hospital readmission and/or emergency department visits in U.S. Veterans with heart failure. Res Social Adm Pharm. 2016;12(5):713-21.
Ishihara, D., Yam, FK. Impact of door to diuretic time in acute decompensated heart failure. Poster presentation at ASHP Mid-Year Meeting. December 2015. New Orleans, LA.
Yam FK, Akers WS., Smith KM, Ramaih CH, Ferraris VC, Flynn JD. Interventions to Improve Guideline Compliance following Coronary Bypass Graft Surgery. Surgery. 2006 Oct;140(4):541-7. B. Positions and Honors
Positions and Employment 2007-2008 Pharmacy Program Coordinator, Cedars-Sinai Medical Center, Los Angeles, CA 2008-2010 Pharmacy Services Supervisor, Cedars-Sinai Medical Center, Los Angeles, CA 2010–Present Associate Clinical Professor, UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, CA 2010-Present Clinical Pharmacist Specialist, Heart Failure, VA San Diego Health-System, La Jolla, CA
Other Experience and Professional Memberships 2005-Present Member, American Society of Health System Pharmacists 2005-Present Member, American College of Clinical Pharmacy 2006-Present Peer Reviewer, Pharmacotherapy 2006-Present Peer Reviewer, Annals of Pharmacotherapy 2010-2012 Chair, Training and Education Committee, San Diego Society of Health System Pharmacists 2010-Present Member, California Society of Health System Pharmacists 2011-2014 Member, American Association of Colleges of Pharmacy 2011-2013 Member, American Society of Consultant Pharmacists 2014-Present Member, Heart Failure Society of America 2014-Present Member, American College of Cardiology
Honors 2011 AFPE Faculty Development Fellowship Award 2011 Board Certified Pharmacotherapy Specialist (BCPS) 2012 UC San Diego SSPPS Class of 2012 Preceptor of the Year Award 2012 University of the Pacific, 2012 Distinguished Service Award 2015 UC San Diego SSPPS Class of 2015 Preceptor of the Year Award 2015 Recognized as Board Certified Pharmacotherapy Specialist with Added Qualifications in Cardiology
C. Contributions to Science
1. Heart failure hospitalization is associated with multiple medication modifications. These modifications often increase medication regimen complexity (MRC) and may increase the risk of readmission and/or emergency department visit. We sought to evaluate the association between changes in medication regimen complexity during hospitalization of patients with heart failure and the risk of readmission or ED visit at 90 days. We found that patients experienced significant increases in MRC but these changes were not associated with an increase in the risk for readmission or ED visit. This work demonstrates that increases in MRC do not necessarily portend worse outcomes. Instead, increases in MRC may be an indicator for medication optimization. As such, complexity scores such as MRC should be interpreted carefully.
Yam, FK. Lew, T., Eraly, SA., Hsiang, Wl., Hirsch, JD., Devor, MJ. Changes in medication regimen complexity and the risk for 90-day hospital readmission and/or emergency department visits in U.S. Veterans with heart failure. Res Social Adm Pharm. 2016;12(5):713-21.
2. Many patients with heart failure (HF) exacerbation experience acute kidney injury or hyperkalemia. Temporary discontinuation of medications that can worsen renal function or cause hyperkalemia is common in the acute care setting. Medications commonly withheld in this setting include renin-angiotensin-aldosterone (RAAS) inhibitors such as angiotensin converting enzyme inhibitors (ACEi’s) and angiotensin receptor blockers (ARB’s). Beta-blockers (BB’s) can also be withheld in patients with acute decompensated heart failure and hemodynamic compromise. The extent to which withheld guideline-directed medical therapies (GDMT) are restarted in the outpatient setting is unknown. We sought to determine the incidence of GDMT discontinuation during HF hospitalization and evaluate if discontinuation of GDMT was associated with a decrease in GDMT use at 60 days. We found that approximately 20% of patients had at least one of their GDMT’s discontinued and at six months less than 50% of these patients had had their GDMT restarted. This data demonstrates that temporary discontinuation of GDMT following HF hospitalization is common and is associated with lower rates of GDMT use at 60 days. Interventions to evaluate readiness for re-initiation prior to hospital discharge or post- discharge can improve rates of GDMT use following HF hospitalization.
Cheng, S. and Yam, FK. Discontinuation of Guideline-Directed Medical Therapies in Veterans Hospitalized with Heart Failure. Abstract Presentation at VA Long Beach Residency Conference. May 2017. Long Beach, CA.
3. Treatment with guideline-directed medical therapy (GDMT) in heart failure with reduced ejection fraction (HFrEF) is recommended before and after implantable cardioverter-defibrillator (ICD) placement. Studies have shown that rates of GDMT prior to ICD implantation is low and suboptimal use of GDMT post-implantation is associated with increased mortality. The impact of adherence to GDMT regimens on arrhythmic event rates post-ICD implantation is unknown. We sought to evaluate the impact of non-adherence to GDMT on arrhythmic event rates post-ICD implantation in patients with HFrEF. We were unable to find an association between GDMT adherence and arrhythmic event rates but our study identified suboptimal GDMT use in ICD patients. Overall, GDMT adherence rates were less than 50% and less than 50% of patients were on at least 50% of GDMT target doses. This study identified suboptimal GDMT use in HF patients with ICD. Interventions to optimize GDMT use in this patient population is needed to improve outcomes.
Le, J., and Yam, FK. Impact of non-adherence to guideline-directed medical therapy and the risk for arrhythmic events in Veterans with heart failure and implantable cardioverter-defibrillators. Poster Presentation at ASHP Mid-Year Meeting. December 2016. Las Vegas, NV.
Complete List of Published Work in MyBibliography: https://www.ncbi.nlm.nih.gov/sites/myncbi/collections/bibliography/52592896/
D. Additional Information: Research Support and/or Scholastic Performance
Completed Research Support
American Foundation for Pharmaceutical Education Yam (PI) 2011-2012
Evaluating Medication Regimen Complexity During Transitions of Care in Elderly Veterans The aim of this study is to develop a predictive model for medication adherence and hospital readmission rates using the medication regimen complexity index tool. Role: Principal Investigator
Amgen Pharmacy Resident Program Grant Shane (PI) 2007-2008
Pharmacy Residency Program in Medication Use Systems The aim of this program was to develop and train pharmacy practitioners in clinical and operational components of medication use systems to improve medication safety within health-systems. Role: Co-Investigator and Program Faculty
ASHP Foundation Health Services Research Yam (PI) 2005-2006
Clinical Inertia: Time to Intervention of Critical A1C Values The aim of this study is to compare the rates of optimization of drug therapy and time to intervention of critical hemoglobin A1C values in Type 2 Diabetics among two models of care: usual medical care vs. pharmacist- managed care. Role: Principal Investigator
February 6, 2020
Dear Dr. Russell,
We appreciate the time taken by the UC San Diego Graduate Council to review the proposal for the Master of Science in Drug Development and Product Management degree program to be offered online. Thank you for your comments in the memo dated December 11, 2019 and for the opportunity to answer the Graduate Council’s questions.
As part of our proposal resubmission, we have addressed the Guidelines for Proposals to Establish Online Master’s Degree Programs (December 11, 2019) within the proposal. In addition to a clean version of the revised proposal, we have included a copy tracking the changes made to the original proposal.
Additionally, in following the Appendix B – Format for the Graduate Degree Program Proposal dated August 2019, Systemwide Academic Senate’s Coordinating Committee on Graduate Affairs (CCGA), we have added Section 1.5 Contributions to Diversity, also addressed in question 5 of the December 11 memo. Furthermore, Appendix B did not specifically address where to discuss online delivery, so we have added Section 2.13 to address it.
We hope that we have adequately addressed all concerns and that the program will be approved in the next review. A detailed point-by-point response to each of the questions raised in the December 11, 2019 memo is included in our email. (Graduate Council questions and comments are italicized).
Sincerely,
Williams Ettouati, Pharm.D. Managing Director MS in Drug Development and Product Management Program
Joseph Ma, Pharm.D. Program Faculty Director MS in Drug Development and Product Management Program Professor
Cc: James McKerrow, Ph.D, M.D. Distinguished Professor Dean Skaggs School of Pharmacy and Pharmaceutical Sciences Associate Vice Chancellor for Health Sciences
Skaggs School of Pharmacy & Pharmaceutical Sciences UC San Diego Health Sciences • 9500 Gilman Drive, # 0000 • La Jolla, CA 92093 T: 858-000-0000 • F: 858-000-0000 • pharmacy.ucsd.edu
1. The MS-DDPM online was developed based on the existing on ground program offered at UC San Diego since fall 2018. (The Council asks proposers to provide additional information about proposers’ experience with the in-person program in the proposal). a. Please provide data about the student profile for the in-person program, particularly about the number of applications, the admitted and acceptance rates, the number of enrolled students, and the number of students completing the program. How do these numbers compare to what was estimated in the original proposal to establish the in- person MS-DDPM? How do they compare with the anticipated numbers for the proposed MS-DDPM online?
Data from Admissions for the MS in Drug Development and Product Management (MS in DDPM) 2018 and 2019 (self-reported by students)
Class of 2019 - 2020
2019 Admissions Statistics: Number of applications submitted: 61 Number of applications accepted: 28 Acceptance rate: 46% Total admitted (enrolled): 25 Completion rate: TBA
2019 -2020 Cohort Statistics: Total cohort: 25 Male: 7 (28%) Female: 18 (72%) International: 11 (44%) Domestic: 14 (56%) Under-Represented Minorities: 5 (20%)
Ethnicity (applicants may have indicated more than one): White/Caucasian: 2 African American/Black: 3 Latinx/Chicanx, or Spanish Origin: 5 Middle Eastern/Middle Eastern American: 1 Asian/Asian American: 7 (1 Korean, 3 Vietnamese, 4 Chinese, 2 Indian, 1 Pakistani) Chose not to disclose 11
Class of 2018 – 2019
2018 Admissions Statistics: Number of applications submitted: 54 Number of applications accepted: 20 Acceptance rate: 37% Total admitted (enrolled): 18
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Completion rate: 100%
2018-2019 Cohort Statistics: Total cohort: 18 Male: 6 (33%) Female: 12 (67%) International: 4 (22%) Under-Represented Minorities: 1 (6%)
Ethnicity (applicants may have indicated more than one): White/Caucasian: 7 African American/Black: 0 Latinx/Chicanx, or Spanish Origin: 1 Middle Eastern/Middle Eastern American: 2 Asian/Asian American: 7 (1 Korean, 3 Vietnamese, 1 Chinese, 1 Indian, 1 Pakistani) Did not disclose: 1
In this current academic year, the enrollment number of 25 students meets the projected number as stated in the original proposal for the on ground program in year two. Enrollment numbers for the initial year (2018-19) of the in-person program were slightly lower than anticipated (18 rather than 24); however, the faculty did not want to compromise the quality of candidates to meet projected numbers. Current recruitment numbers with applications in progress indicate we should be able to admit the projected number of 30 in 2020. Of note is that though the program is only in its second year, it is already self-sustaining, fiscally sound, and generating sufficient funds for reinvestment into the program in year three and beyond.
As described in the current proposal, offering the program online will make the degree program more accessible to students throughout the United States, including URMs and full-time working professionals not located in the San Diego region, as well as international students. The online presence will help to minimize physical barriers in the context of the in-person program. The online program will be identical to the in-person program in terms of quality of education and total number of units (36). Efficiencies will be gained in program operations and teaching as the courses are refined, and we anticipate that a cohort of up to 65 students will enroll in the inaugural online academic year.
b. What were the results of the program’s efforts to track and examine student performance and success in the in-person program?
Our first cohort of 18 students for the academic year 2018 – 2019 all graduated from the program. Student performance in the in-person program was examined by different types of assessments in each course and by a comprehensive examination. The comprehensive examination was an 84-question examination that was administered at the end of the academic year. The content was built from each course’s goals and objectives with faculty course chair(s) responsible for providing examination questions. The examination questions were then reviewed internally by the MS in Drug Development and Product Management (MS in DDPM) Steering Committee, which is comprised of the Managing
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Faculty Director, Program Faculty Director, and two full-time Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) faculty. Passing of this examination was required for graduation and degree conferral. For the academic year 2018 – 2019, the passing rate of the comprehensive examination was 100% (n=18).
Tracking student performance in each course was the responsibility of the faculty course chair(s) and included multiple methods of assessment, including but not limited to quizzes, midterm and/or final examinations, case-based study review, group presentations, and individual presentations. For example, for the in-person course DDPM210 Biologics and Biosimilars Drug Development, the primary method of assessment was the quality of student responses to questions from graded case studies. Students were able to work in assigned student groups to review the required reading materials and to complete the case study questions. Successful completion of each course was recorded as graded coursework and completed credit units on the student’s academic transcripts. See MS-DDPM proposal Section 2.13.7.
In addition, we are pleased that the students who completed the program in 2019 are reporting that they have gained what they hoped to achieve in earning the MS in DDPM degree in terms of providing foundational knowledge, promotional opportunities and/or career advancements.
c. Section 1.4 notes that the program was established in a face-to-face format to best understand the teaching requirements of the students and program. It is not clear to the Council what lessons were learned from the existing in-person MS-DDPM program and how this informed the design of the MS-DDPM online. Please include details in the proposal about the insights gained in the last two years and how they apply to the MS- DDPM online curriculum.
Students from the in-person program expressed satisfaction with small group discussions and assignments for team-based assessments. In addition, they appreciated the utilization of case studies that provided “real world examples” that could be applied to and/or integrated with learned concepts/principles from didactic content. For the online program, we intend to leverage what has been gained from the in-person program, from the utilization of small group discussions, selection of assignments for team-based assessment, and integration of case studies.
During the application process, one insight gained was the inability to attract candidates who resided outside Southern California, or were out-of-state or out-of-country. Several of these applicants were offered admission into our program but declined to accept. The primary reason for declining was the inability for the candidate to relocate because of financial and/or personal hardships. In addition, even though the course schedules were designed to accommodate our students’ work commitments, and the majority of our students were full-time employees in the San Diego area, attending evening courses was at times stressful and challenging for our students. Over the 2018 – 2019 academic year, we observed periodic student absences from courses. The primary reason for the absences were mainly related to work schedules and other issues that would conflict with the student being able to attend the in-person DDPM course. The proposed online program aims to minimize the students’ stress by way of having course content readily and easily available rather than requiring participation a live, in-person presentation.
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d. Please provide an evaluation of the effectiveness of the flipped courses used in the in-person program.
Several of the courses provided elements of a flipped learning environment by way of incorporating in- class time for students to actively engage in knowledge building (i.e., learning culture), to provide intentional content to maximize student-centered learning and having course faculty serve in the role as Professional Educator via observing students and providing them with immediate feedback on group assignments. For example, in the DDPM 208 Principles of Marketing Strategy, Product Value, and Life Cycle Management course, marketing case studies were assigned to a team of 4 – 5 students. Students worked with their assigned teams to review, prepare, analyze, and present case studies to the class, with each team then submitting a written report answering questions posed during the case study presentation and from the case report reading. The grading for each case study assignment was two- fold: Individual student performance and overall team performance. Based on student feedback primarily from conversations between students and faculty, students expressed strong satisfaction with the use of case-based, student-centered learning. Other courses in the program have also utilized this framework for integrating case studies into the respective coursework. See MS in DDPM proposal 2.13 Online Delivery.
2. The program will rely heavily on the Teaching + Learning Commons (Commons) for course design but the proposal does not provide specific details about course design and assessment. Please provide a report on the course design research and detail the services that the Commons will provide.
a. What are the program’s expectations of the Commons in terms of course design as opposed to the instructor’s role? Specifically, will the Commons be “designing” courses or “advising” instructors on course design?
Instructional Designers (IDs) from the Commons’ Digital Learning Hub will work in partnership with course chair(s) from each course to help them design and build the online format. As is being done for the current in-person program, for the proposed online program, course chair(s) will provide oversight in the creation of course content, composing course goals and objectives, determining methods of student assessment(s), and selecting lecturers to provide didactic, expert instruction. The course chair(s) is the subject matter expert and is responsible for the course content, assignments and assessments. Course chair(s) define what students interact with and consume within the course. Except for the Managing Director and Faculty Director, most faculty do not have experience teaching in the online modality. The IDs have expertise in pedagogical techniques and learning tools in an online setting and will provide guidance to the faculty on how students will interact with and access their content. They will assist with the development of multimedia components, creating digital learning assets and building the course on the learning management system as needed. Throughout the instructional design process, each component will be aligned with learning outcomes and designed to provide faculty with analytical and anecdotal feedback that informs student performance and engagement. The IDs will also provide pedagogical and technical training for faculty and program staff on how to use the LMS and integrated technical tools when they teach their courses. See MS in DDPM proposal Section 2.13 Online Delivery.
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Partnering with the Teaching and Learning Commons’ instructional designers for online course design is critical for the following compliance reasons. All online courses must meet the Electronic Accessibility standards established by UCOP (https://www.ucop.edu/electronic-accessibility/). Additionally, the campus has adopted Quality Matters (QM) Standards as the benchmark for ensuring high quality online courses. Courses that meet QM Standards reflect critical design components that facilitate engagement and support student success. The Instructional Designers are certified in Quality Matters and accessibility and will work with the faculty to make sure each course is compliant. See MS in DDPM proposal Section 2.13 Online Delivery.
b. Please clearly account for the costs associated with TLC’s time in the program’s budget (both in terms of course design and ongoing tech support).
The Campus (Office of Executive Vice Chancellor) has invested 9 FTEs and ~$1.3M of the overall budget of the Teaching + Learning Commons in dedicated support for digital course and program design, development and assessment via The Digital Learning Hub (7 FTE) and the Assessment Hub (2 FTE). Likewise, the EVC has invested 7 FTEs to Information Technology Services (ITS) for dedicated Ed Tech Staffing to provide technology and media support for digital course production and technical support to learners. The services provided by the Teaching + Learning Commons and ITS for digital learning are available to faculty campus-wide who are resourced by the Strategic Academic Program Development Initiative (Educational Innovation) and thus do not need to be accounted for in the program budget. See MS in DDPM proposal Section 6 Resource Requirement and Impact on the Academic Unit.
3. The proposal was submitted prior to EVC Simmons’ July 19, 2019 announcement regarding new platforms for hosting UC San Diego online courses and programs. The Council asks that proposers review the proposal with TLC to ensure that the design for the online format of the degree program is in compliance. If it is not, please modify the proposal to comply.
This proposal is compliant with EVC Simmon’s July 19, 2019 announcement regarding new platforms. The DDPM online degree will be hosted on our Canvas Learning Management System. See Section 2.13 Online Delivery.
4. The proposal notes that voluntary faculty will assist core faculty in student advising. How are these faculty appointed and monitored by the core faculty?
DDPM Voluntary Faculty are appointed and monitored by SSPPS. Individuals who provide significant teaching by way of chairing or co-chairing a course to our students are eligible for a voluntary faculty appointment at SSPPS. With the exception of a single course (DDPM211 Managed Markets, Post- marketing, Drug Utilization Management), all other DDPM courses involve a UC San Diego faculty co- chair. These individuals must be teaching students within the next 12 months to qualify. Applicants complete an appointment request form and provide an updated CV or resume. The application materials are reviewed and approved by an SSPPS Faculty committee. If approved, the duration of the appointment is for a period of 3 years, during which the UC San Diego faculty will oversee the work of the voluntary faculty. Afterward, the individual must reapply and will undergo the same process of
5 submitting documents and then a review of the application. See MS in DDPM proposal Section 4 Faculty.
a. What are the expectations for voluntary faculty engagement with students?
DDPM Voluntary Faculty (VF) are involved as course chairs or co-chairs in designing courses to reflect the needs of the Pharmaceutical, Biotechnology and Managed Care industries and are a vital part of creating a highly innovative educational program. Our VF work in synergy with our Core SSPPS Faculty to define student learning objectives, develop related student assessment strategies, and provide teaching and learning activities.
Our DDPM VF are MDs, PharmDs, and PhDs who are professional executives with years of work experience in industry. They provide not only real-world drug development and management practical expertise but in addition provide networking opportunities to our students. Our VF engagement also may provide career guidance and student mentoring based on their area of expertise and brings critical contributions to teaching and learning of our students. Our VFs are an integral part of DDPM program, and help create an exceptional culture for student success. See MS in DDPM proposal Section 4 Faculty.
5. In August 2019, the Systemwide Academic Senate’s Coordinating Committee on Graduate Affairs (CCGA) updated its proposal format to include Section 1.5 for contributions to diversity. Please add this section to the proposal and clearly articulate the program’s diversity plans and goals. It is not sufficient to state that the program will ensure “a good balance” between males, females, URMs, and representatives from industry. How will moving to an online format impact the program’s diversity goals?
The MS in DDPM program leaders are dedicated to equity, diversity and inclusion and are committed to enhancing accessibility for all students. As a professional degree program, we are preparing students for success in top organizations and companies. These organizations and companies thrive by hiring talented diverse individuals, and accordingly we strive to include members of diverse communities in our cohort so their perspectives and experiences will enrich the program.
Our outreach and marketing strategy is based in equity, diversity and inclusion. Certain marketing and outreach efforts will be made to directly target underserved communities through organizations such as the Society for Advancement of Chicanos/Hispanics and Native Americans in Science (SACNAS), which is inclusive in its membership. According to the SACNAS website, 40% of its members are pursuing careers in Life Sciences (https://www.sacnas.org/). We will utilize LinkedIn and other social media to market to diverse groups such as Women of Color in Pharma (https://wocip.org/). Lastly, the program will collaborate and align its goals with the Graduate Division’s diversity and inclusion outreach efforts, such as the Annual Biomedical Research Conference for Minority Students (https://www.abrcms.org). The UC San Diego Extension Marketing team will help direct marketing and outreach efforts to reach diverse populations.
The target market for the degree program is early career professionals in the biotechnology and pharmaceutical industries. Our diversity goals will thus align with the reported data about current
6 representation of employed URM in these industries. According to the most recent data available from the US Bureau of Labor Statistics (https://www.bls.gov/cps/cpsaat18.htm) 9.4% of the pharmaceutical and medicine manufacturing workforce is comprised of individuals identifying their race as Black or African American, 12.2% identifying their ethnicity as Hispanic or Latino, and 15.7% identifying as Asian. The MS in DDPM 2018 – 2019 cohort comprises 20% URM. To help us maintain successful marketing, and recruitment efforts, we will collaborate with a team of knowledgeable and diverse individuals who consider Equity Diversity and Inclusion (EDI) at each stage and will examine best practices in academia.
The admissions committee conducts a holistic review process that considers the work experience of each applicant, letters of recommendation, and an applicant’s statement of intent about why this master’s degree program will help advance their career. Subsequently, for any potential applicant, an in- person or teleconference interview is conducted. We do not require the GRE with the understanding that the GRE test scores may not reveal the potential of an applicant, and that it is often associated with impeding the academic advancement of URM or first-generation students.
Financial considerations are often a barrier for students to attend the program. Scholarships are awarded based on merit and factors that enhance diversity in the program. These scholarships would help reduce financial barriers and improve access to the program for students from underserved communities. Additionally, the online program format will enable students to pursue the MS in DDPM without the costs associated with relocation and loss of income.
The program faculty and administrators are committed to creating an online academic environment that encourages all students to follow their intellectual curiosity and to pursue opportunities to make an impact in their own unique way. Students will be respected for their perspectives, backgrounds, and experiences. We will be leaders in creating an educational online experience where all feel included and experience equitable opportunity in achieving their aspirations. See MS in DDPM proposal Section 1.5 Contributions to Diversity.
The following information will be featured on the program website and program marketing collateral:
What is EDI (Equity, Diversity, and Inclusion) to UC San Diego?
Diversity refers to the variety of personal experiences, values, and worldviews that arise from differences of culture and circumstance. Such differences include race, ethnicity, gender, age, religion, political views, language, abilities/disabilities, sexual orientation, socioeconomic status, and geographic region.
Equity is the guarantee of fair treatment, access, opportunity, and advancement for all students, faculty, and staff…while at the same time striving to identify and eliminate barriers that have prevented the full participation of marginalized groups.
Inclusion is the act of creating environments in which any individual or group can feel welcomed, respected, supported, and valued.
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6. Administrative support for the program will be provided by University Extension. Please provide more details about the services provided by Extension and the partnership with SSPPS.
a. How will the faculty retain oversight over the quality of the program and monitor the student experience?
The DDPM Faculty Steering Committee is responsible for reviewing applications, interviewing and nominating to the Graduate Division applicants for admission. As previously mentioned in question 2.a. faculty course chair(s) will provide oversight in the creation of course content, composing course goals and objectives, determining methods of student assessment(s), and the selection of lecturers to provide didactic, expert instruction. Monitoring of the student experience of each course will be the responsibility of the faculty course chair(s) and will occur during the course and after course completion. During the course, the method(s) of assessment will remain the primary modality regarding student performance. For example, in the DDPM204 Clinical Trial Development course, one method of assessment is a group presentation of an FDA-approved drug with content focusing on the study design of clinical trials. The faculty course chairs and/or course assistant for the DDPM204 proposed online course will monitor the student experience of the group presentation by engaging in a question and answer (Q&A) session/discussion forum and completing an 18-item grading rubric focusing on presentation content, presentation style, and the Q&A session/discussion forum. After the course, monitoring student experience will be via review of the student course evaluations. Providing overall support for the DDPM program, there is the DDPM Steering Committee comprised of the Managing Faculty Director, Faculty Program Director, and two full-time SSPPS faculty members in addition to the University Extension administrative support team. For each course in the proposed online program, a formalized review by the faculty on the DDPM Steering committee will be conducted yearly (for each course) to ensure appropriateness and updating of the course content. See MS in DDPM proposal Section 2.13.1.
The courses will be designed with multiple opportunities for students to participate in online discussion forums to ask questions and provide feedback. Course faculty chairs and program administrative staff will monitor the discussion forums during the course to assess the student experience and make course adjustments when necessary. Additionally, each course will have an end of course survey which solicits feedback on the course content and the online learning experience. The Canvas Learning Management platform provides robust learning analytics on the participation and performance of each individual student and the aggregate class. The Digital Learning team will train each instructor on how to utilize the Canvas learning analytics tools for their course. See MS in DDPM proposal Section 2.13. Online Delivery.
UC San Diego Extension will provide administrative support under the direction of the Managing Faculty Director, Program Faculty Direction, and two full-time SSPPS faculty who comprise the DDPM Steering Committee. UC San Diego Extension has extensive experience in administering self-supporting, professionally oriented degree programs at UC San Diego. See MS in DDPM proposal Sections 2.13.6 Student Advising and 6 Resource Requirement and Impact on the Academic Unit.
The services provided by UC San Diego Extension include, but are not limited to:
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• Marketing • Developing and executing program administrative policies • Overseeing financial management • Collecting applications and setting up candidate interviews with DDPM Steering Committee faculty • Providing course chair and co-chair servicing (i.e. setting up UCSD email addresses and Canvas accounts) • Providing student servicing (i.e. Canvas overview, orientation meeting)
The online MS in DDPM program will be designed and implemented utilizing resources available through the Strategic Academic Program Development (SAPD) initiative, with the Education Research and Assessment Hub in the Teaching and Learning Commons providing guidance and direction for developing the courses and program for the online degree.
b. Please provide details about how the student support and advising staff will interact with students in an online environment (more details about proposal requirements are included in Section VII.3 of the Guidelines)
The DDPM online degree program will employ a multifaceted advising and support system to help address the needs of online students. Both asynchronous and synchronous electronic communication technologies (summarized below and integrated into the Canvas Learning Management System) will be used to accommodate the challenges of scheduling and different time zones.
Real time (synchronous) Toll-free numbers, web conferencing (Zoom), virtual meeting support tools rooms, online chats
Asynchronous support tools Online forms, email, forums and discussion boards
The Canvas Learning Management Platform has built in communication tools that allow the instructors and staff to interact with students both as a group and individually. There will be discussion forums dedicated to student support and advising which will allow students to ask questions and seek support from their peers and from the advising staff. The support and advising staff will use Zoom, the campus web conferencing tool, to schedule live advisory and student support sessions. These sessions will allow virtual real-time interactions (two-way video and audio) between students and staff.
An online advising portal, integrated with the program website, will also be developed, allowing students to obtain answers to questions (e.g. FAQs) that do not require dialogue, such as administrative information and educational policies and procedures. See MS in DDPM proposal Section 2.13.
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