Biopharmaceutical Industry PharmD Fellowships Unique Fellowships, Endless Opportunities Table of Contents About Biogen For more than 35 years, Biogen has been helping of disease biology and working to develop potentially Introduction to improve the lives of people living with serious life-changing treatments for the people suffering from medical conditions. Since our founding in 1978, we’ve these conditions. Biogen is a truly global organization, A Message From Al Sandrock, Executive Vice President, Chief Medical Officer, produced therapies for diseases that affect hundreds with more than 7000 employees worldwide. In addition Head, Development and Worldwide Medical...... 1 of thousands of people around the world. to our headquarters in Cambridge, Massachusetts, we have offices in the United States, Canada, Australia, About Biogen...... 2 The company was founded in Zurich, Switzerland, by Japan, and throughout Europe. We also have a direct scientists who were the first to clone and express commercial presence in 30 countries and distribution MCPHS University Faculty Preceptors...... 3 interferon, the monoclonal antibody that led to the agreements in more than 60 additional countries. development of our first multiple sclerosis (MS) therapy, About MCPHS University...... 4 Working to solve difficult challenges is the foundation AVONEX®. A pioneer in the biotechnology industry and of both our research and our corporate responsibility. About the Fellowships...... 5 one of the first biotech companies, Biogen now has The same passion that drives our science is reflected the world’s leading portfolio of MS therapies and in in our corporate citizenship, environmental sustainability, Eligibility and Application Procedure...... 5 2014 introduced new treatments for hemophilia A and and commitment to diversity. B, bringing the first innovation to patients in almost two decades. We are further applying our expertise Fellowships to solve some of the most challenging and complex diseases in neurology, including Alzheimer’s disease, Led by world-class research and development, Regulatory Sciences/Safety and Benefit-Risk Management....7 spinal muscular atrophy (SMA), Parkinson’s disease, Biogen uses novel science and leading-edge Dear Prospective Biogen Fellow, and amyotrophic lateral sclerosis (ALS). The pace of Safety and Benefit-Risk Management...... 9 Thank you for your interest in the Biogen Post-PharmD Fellowship discovery and innovation in neuroscience is accelerating technologies to discover, develop, commercialize, rapidly, bringing the promise of incredible advances to Regulatory Sciences–Advertising and Promotion...... 11 Programs. The evolving and growing world of biopharmaceutical and manufacture transformative therapies for industry has opened up a tremendous amount of opportunity for patients. As we help lead this transformative period in Regulatory Sciences–Trial Master File/Clinical pharmacists looking for an alternative and diverse career path. neuroscience, Biogen is driving a deeper understanding patients with few or no treatment options. Trial Application...... 13 Since the start of this fellowship, Biogen, in collaboration with Global Medical Writing...... 15 MCPHS University, has trained and promoted the role of the Doctor of Pharmacy within the company, academia, and the industry as a Worldwide Medical...... 17 whole. Fellows completing this program not only grow professionally in terms of skills and expertise, but have also made a substantial Real-World Outcomes, Innovative Partnerships, and Insights...... 19 impact on programs integral to the success of Biogen. Biogen is one of the oldest independent biotechnology companies in the world focused on developing and delivering therapies for Program Information neurodegenerative and autoimmune disorders. We provide a culture of innovation, inclusiveness, and empowerment. This environment allows Frequently Asked Questions...... 21 for personal and professional growth, all while creating an atmosphere of learning and new opportunities for our employees. Our passion and Fellowship Alumni...... 22 focus is not only on improving the lives of patients, but also extends to supporting the local community, nurturing science education for students of every age, and maximizing our environmental sustainability.
We are at an exciting time at Biogen and we are committed to “Our commitment is to educate our fellows on the “The Worldwide Medical fellowship provides fellows the pursuing science that truly matters. Best of luck as you explore the complex, rapidly evolving world of biopharmaceutical drug opportunity to understand how they can contribute to the different opportunities available to you, and I strongly encourage you development and to provide them with the necessary tools global medical function within Biogen R&D; it challenges to consider the Biogen fellowship. to help them shape their own careers.” them to learn new capabilities in research, development, and commercial areas to enhance their leadership competencies Carmen Bozic, MD within the dynamic and growing biopharmaceutical industry.” Sincerely, Senior Vice President Global Development Ralph Kern, MD Al Sandrock, MD, PhD Senior Vice President Executive Vice President, Chief Medical Officer, Worldwide Medical Head, Development and Worldwide Medical
About Biogen | 2 MCPHS University Faculty Preceptors About MCPHS University Lynn Squillace, JD, MPH Catherine Taglieri, BSP, MCPHS University provides an academic environment to guide and support fellows toward a successful career Director of Regulatory Sciences PharmD, RPh in the biopharmaceutical industry. As a private institution with a history of specializing in the health sciences, & Health Policy Assistant Professor of MCPHS University offers programs that embody scholarship, professional service, and community outreach. Assistant Professor Pharmacy Practice Through MCPHS University, the fellow will have the opportunity to gain teaching and research experience in an academic setting. Throughout the program, MCPHS University faculty and company program leaders mentor fellows according to each fellow’s scholarly and professional interests. As an adjunct assistant professor at MCPHS University, each fellow may have the opportunity to • develop, coordinate, and teach pharmacy courses. • co-precept students on advanced experiential rotations. • create and publish scholarly research and review articles. • present data at scientific and clinical meetings. Michael Steinberg, BA, BS, Stefanie Nigro, PharmD, PharmD, BCOP BCACP, BC-ADM • participate in professional development seminars. Professor of Pharmacy Practice Assistant Professor
Kristine Willett, William McCloskey, BA, BS, PharmD, FASHP PharmD, RPh Associate Professor of Professor and Vice-Chair, Pharmacy Practice Pharmacy Practice
Brian Rittenhouse, MS, PhD Pharmaceutical Business and Administrative Sciences
3 | MCPHS University Faculty Preceptors About MCPHS University | 4 About the Fellowships Fellowship Contact Information Biogen, in collaboration with MCPHS University, offers 7 unique fellowship programs to promote the role of Doctor of Pharmacy (PharmD) within the biopharmaceutical industry: Email Address • Regulatory Sciences/Safety and Benefit-Risk Management (Reg/SABR) • Safety and Benefit-Risk Management (SABR) Reg/SABR [email protected] • Regulatory Sciences–Advertising and Promotion (Reg–AP) • Regulatory Sciences–Trial Master File/Clinical Trial Application (Reg–TMF/CTA) SABR [email protected] • Global Medical Writing (GMW) • Worldwide Medical (WWM)
2 • Real-World Outcomes, Innovative Partnerships, and Insights (RI ) Reg-AP [email protected] Fellows will gain extensive experience through a variety of practical activities in both industry and academic settings, which will enhance the potential for accelerated career development. Reg-TMF/CTA [email protected] Eligibility • Applicants must hold a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy by the GMW [email protected] commencement of the program. • Candidates must have excellent written and oral (ie, verbal) communication skills and a strong interest in pursuing a career within the biopharmaceutical industry. WWM [email protected] • The Biogen fellows will be selected on a nationally competitive basis. • All fellowships last 2 years with a start date of July 1st. RI2 [email protected] Application Procedure • Candidates are encouraged to request a preliminary interview at the American Society of Health-System Pharmacists (ASHP) midyear meeting through the Personal Placement Service (PPS) website. • Interested candidates must submit their application materials online at http://www.mcphs.edu/BiopharmaceuticalFellowships, by December 20th. – Please submit a letter of intent, curriculum vitae, three references with contact information, and unofficial college transcript(s). • Please submit 3 letters of recommendation to the program’s email address, which can be found in the table on the next page.
5 | About the Fellowships About the Fellowships | 6 Regulatory Sciences/Safety and Benefit-Risk Management Fellowship 2-YEAR PROGRAM
REGULATORY SCIENCES 4 months SAFETY AND BENEFIT-RISK MANAGEMENT 10 months ELECTIVE 10 months
Regulatory Sciences Safety and Benefit-Risk Program Directors “The Biogen fellowship programs have Management (SABR) “The success of our program is a tribute been a source of incredibly talented Regulatory Sciences is a well-integrated global to highly motivated fellows, coupled with and inspiring individuals who have department that provides worldwide strategic contributed to the recognition of the Biogen is responsible for the continuous assessment an exceptionally supportive environment regulatory guidance and operational support for programs throughout the company.” of the benefit-risk relationship of all of its products— throughout the company.” Biogen’s development and commercial programs. starting in the early stages of development and Mehdi Chakir, PharmD Stacie Knight The fellow will acquire a better understanding of continuing through the postmarketing phase. Members Director, SABR Director, Regulatory Sciences the dynamics of the drug development process of the SABR department are continuously working to throughout the life cycle of our products, from early gain a better understanding of the safety profile of development through approval and commercialization. marketed products and those in development, in order During the rotation in Regulatory Sciences, the fellow to provide the medical community and patients with the Second-Year Fellows data necessary to make an informed decision will have the opportunity to gain experience in the “Fellows in the Biogen Regulatory Sciences and Safety & Benefit-Risk Management program have regarding disease management. different functions of the regulatory department, an unparalleled opportunity to see drug development from multiple positions. Fellows build a diverse which are as follows. During the rotation in SABR, the fellow will have an experience base that lets them stand apart.” • Advertising and Promotion (AP) opportunity to rotate through 3 general areas: Colin Gillis, PharmD • Operations • Global Case Management Northeastern University Bouvé College of Health Sciences • Labeling • Pharmacovigilance (PV) Scientists “This program is a unique opportunity for fellows to gain extensive practical experience in an invigorating • Clinical Trial Applications (CTA) • Epidemiology environment and foster the skills necessary for success in the biopharmaceutical industry.”
Bhumi Patel, PharmD University of the Sciences Philadelphia College of Pharmacy
Elective Options First-Year Fellows
The fellow will have the opportunity to spend up to “The partnership between MCPHS and Biogen provides a challenging yet nurturing environment for 4 months in another department within Biogen. fellows to be fully immersed in high-profile projects, driving personal and professional growth through Departments may include, but are not limited to: guidance from an impressive network of experienced individuals within the biopharmaceutical industry.” • Clinical Drug Supply Chain Kathy Lu, PharmD University of the Sciences Philadelphia College of Pharmacy • Global Clinical Operations • Global Commercial Strategy • Health Economics and Outcomes Research “The Regulatory Sciences and Safety & Benefit-Risk Management fellowship provides a unique platform that facilitates exposure to multiple facets of industry allowing for involvement in dynamic and valuable • Marketing projects that foster professional and personal growth.” Also, the fellow will have the opportunity to precept PharmD students. Tina Chhabra, PharmD Virginia Commonwealth University School of Pharmacy
7 | Regulatory Sciences/Safety and Benefit-Risk Management Regulatory Sciences/Safety and Benefit-Risk Management | 8 Safety and Benefit-Risk Management Fellowship 2-YEAR PROGRAM
SAFETY OPERATIONS 4 months PHARMACOVIGILANCE/ EPIDEMIOLOGY 10 months ELECTIVE 10 months
About Safety and Program Director Benefit-Risk Management “The success of our program is a tribute to highly motivated fellows, coupled with an exceptionally supportive environment throughout the company.” Biogen is responsible for the continuous assessment Safety Operations: During this rotation, the fellow of the benefit-risk relationship of all of its products— will become knowledgeable about the adverse event Mehdi Chakir, PharmD starting in the early stages of development and reporting process including initial review and triage, Director, SABR continuing through the postmarketing phase. Members adverse event report assessment, and distribution rules. of the Safety and Benefit-Risk Management department The fellow will also enhance his or her understanding of are continuously working to gain a better understanding clinical trial safety, ICSR reporting, global pharmacovigilance of the safety profile of marketed products and those in regulations and guidelines, safety data exchange development in order to provide the medical community agreements, and vendor oversight. and patients with the data necessary to make an informed decision regarding disease management. Epidemiology: During this rotation, the fellow will work closely with epidemiologists to provide REMS support, This 2-year Safety and Benefit-Risk fellowship understand and evaluate real-world data, and prepare is designed to provide an in-depth and hands-on epidemiology-based product summaries experience. Through this program, the fellow will gain exposure to the following three general areas: Pharmacovigilance (PV) Scientists: During this rotation, the fellow will engage in safety surveillance activities and prepare and review signal evaluations, periodic safety update reports, and risk management plans utilizing the training and skills gained through previous rotations.
Elective Options • Regulatory Sciences • Global Medical Writing • Clinical Drug Supply Chain • Global Clinical Operations • Global Commercial Strategy • Health Economics and Outcomes Research
9 | Safety and Benefit-Risk Management Safety and Benefit-Risk Management | 10 Regulatory Sciences–Advertising and Promotion Fellowship 2-YEAR PROGRAM
REGULATORY SCIENCES–AP 6 months ELECTIVE 6 months 9 months US MARKETING 3 months REGULATORY SCIENCES–AP
About Regulatory Sciences–AP Program Director Regulatory Sciences–Advertising and Promotion (AP) Regulatory Sciences–AP is an area in which skills cannot “Our fellowship program provides individuals with the opportunity to experience the evolving regulatory is one of the functional groups within the Regulatory be obtained solely from a professional degree; instead, landscape of advertising, labeling, and promotion. In addition, it offers unique rotations, including Sciences organization that support Biogen’s the necessary knowledge is gained predominantly commercial marketing, that position fellows competitively within the biopharmaceutical industry.” development and commercial programs. The Regulatory through on-the-job training and hands-on experience. Tammy Phinney Sciences–AP team is responsible for providing Vice President, US Regulatory Sciences Biogen with strategic, high-quality, timely, and decisive Biogen recognizes this critical need for experienced regulatory advice on advertising and promotional Regulatory Sciences–AP professionals and has materials, communications, and company activities partnered with the marketing department to offer a in accordance with FDA regulations, company policies, fellowship with opportunities to experience and learn the following: and business goals. Also, this team is responsible for Second-Year Fellow the creation, revision, and maintenance of US product • the FDA regulations that govern advertising, labeling. The AP group leads communications with labeling, and promotion “This fellowship program offers the opportunity to work closely with experienced and motivated regulatory agencies related to US labeling, advertising, individuals to gain valuable, hands-on regulatory experience. Through this unique opportunity, the fellow • how to accurately and effectively apply regulations and promotion. will acquire the necessary skills and network to be successful in the biopharmaceutical industry.” and provide guidance This 2-year Regulatory Sciences–AP fellowship is • how promotional materials are developed through Sui Kate Ho, PharmD Purdue University College of Pharmacy designed to provide advanced, hands-on experience. the commercial organization The fellowship provides Regulatory Sciences–AP professionals with comprehensive knowledge of The overall goal of the program is to prepare each fellow advertising and labeling regulations and real-world to be a successful Regulatory Sciences–AP professional applications for the development of product labels with a solid understanding of how FDA regulations are and the oversight of promotional material from the followed by the biopharmaceutical industry and enforced First-Year Fellow by the FDA. Upon completion of the fellowship, the biopharmaceutical perspective. “This fellowship is an extremely well-structured path for those interested in the commercial side of experienced fellow will be well-prepared to enter into an advanced career in Regulatory Sciences–AP. regulatory sciences. While working with a supportive and dedicated team, I’ve been given a unique chance to experience the many facets of advertising, labeling, and promotion, as well as learn the necessary skills to excel in this particular field.”
Elective Options Anita Kachappilly, PharmD St. John’s University College of Pharmacy and Health Sciences The fellow will have the opportunity to spend up to 3 months in another department within Biogen. Departments may include, but are not limited to: • Worldwide Medical • Global Commercial Strategy • Health Economics and Outcomes Research • Safety and Benefit-Risk Management • Regulatory Sciences Also, the fellow will have the opportunity to precept PharmD students.
11 | Regulatory Sciences–Advertising and Promotion Regulatory Sciences–Advertising and Promotion | 12 Regulatory Sciences–Trial Master File/Clinical Trial Application Fellowship 2-YEAR PROGRAM
FUNCTIONAL GROUP ROTATIONS 12 months 12 months CORE FUNCTIONAL GROUP
About Regulatory Sciences–TMF/CTA Program Directors This fellowship will primarily focus on the Trial Master During the second year, the fellow will gain direct “With an emphasis on effective leadership and open communication, the fellowship provides a strong File (TMF) and Clinical Trial Application (CTA). Over the experience within the CTA team, which is responsible network and numerous collaborative opportunities within regulatory functions. As a core member of course of 2 years, the fellow will be a member of cross- for managing international clinical trial applications with the TMF/CTA team, fellows will be exposed to a broad insight of regulatory processes on a global level functional teams and work with key individuals that have health authorities. In doing so, the team is responsible and develop a thorough understanding of clinical regulatory documents.” a comprehensive knowledge of regulatory requirements for the oversight of Clinical Research Organizations for the planning, conduct, and reporting of clinical trials. (CRO) and the collaboration with Biogen to ensure Vinita Leslie, MA Maintenance of the accurate and appropriate documentation timely execution of the application submissions. Director, Regulatory Sciences is needed for managing the conduct of clinical trials and As an integral member of the cross-functional study enables evaluation by audit or inspection for Good Clinical team which provides regulatory strategy for the studies, Practices (GCP) compliance. The fellow will also have the the fellow will support the CTA lead with startup, “The second year of the TMF/CTA Regulatory fellowship offers in-depth learning and experience in opportunity to complete collaborative initiatives within maintenance, and close-out activities for various execution of clinical trial applications around the world. The fellow will be an integral part of the study Regulatory Sciences. studies. The team provides regulatory training and management team and will provide the regulatory guidance needed to initiate and maintain regulatory education to increase the fellow’s exposure to multiple approvals in a rapidly changing global environment.” The TMF is considered the autobiography of a study and aspects of Regulatory Sciences. is our evidence that the integrity of the trial data, study Mugdha Sitole, PharmD analysis, and study conclusions are credible, and that Manager, Regulatory Sciences patient rights and safety have been protected. During the first year of the fellowship, the fellow will obtain a functional working knowledge within the TMF group as a support system for the TMF Study Owners, Manager, and Process Owner. The team provides comprehensive collaborative opportunities with TMF partners such First-Year Fellow as Global Clinical Operations, Safety and Benefit Risk “I feel incredibly grateful to work in an environment where the culture is collaborative, not competitive. Management, and Records Management. This provides the foundation for the second year of the fellowship. The TMF & CTA team at Biogen provides a great opportunity for professional and personal growth, as well as multiple teaching opportunities with MCPHS. As valued members of this multidisciplinary team, fellows gain increased exposure to the world of industry and regulatory sciences, and acquire an in-depth Elective Options knowledge of the submission and compliance process on a global scale.” The fellow will have the opportunity to spend up to April Nguyen, PharmD 3 months in another department within Biogen. University of the Pacific Thomas J. Long School of Pharmacy & Health Sciences Departments may include, but are not limited to: • Worldwide Medical • Global Commercial Strategy • Health Economics and Outcomes Research • Safety and Benefit-Risk Management • Regulatory Sciences Also, the fellow will have the opportunity to precept PharmD students.
13 | Regulatory Sciences–TMF/CTA Regulatory Sciences–TMF/CTA | 14 Global Medical Writing Fellowship 2-YEAR PROGRAM
GLOBAL MEDICAL WRITING 24 months
About Global Medical Writing Biogen’s Global Medical Writing fellowship will Sciences, Global Clinical Operations, Safety Program Directors focus on development of clinical and regulatory and Benefit Risk Management, Biostatistics and “Medical Writing offers a great vantage point to be involved in a wide range of activities that documents. In the course of 2 years, the fellow Clinical Data Sciences, and Quality and Compliance. support drug development.” will work with cross-functional teams to develop Working closely with this cross-functional team an understanding of the drug development process, provides comprehensive training and education as Mark Fielding, PhD including regulatory documentation requirements for well as broad exposure to career opportunities in Director, Medical Writing the planning, conduct, and reporting of clinical trials, Global Development. Understanding how study-level as well as the submission, approval, and maintenance documents are structured and written will provide the of marketing authorization for products. fellow with the foundation to understand how these documents support the overall drug development “The medical writing fellowship program offers a unique opportunity to gain knowledge on clinical Study-level documents: During the first year of the process at the program level. fellowship, the fellow will obtain a functional working development through the preparation of clinical and regulatory documents.” knowledge of study-level documents such as clinical Program-level documents: During the second year study protocols and reports required for the conduct of the fellowship, the fellow will gain direct experience Begona Ruiz Perez, PhD Associate Director, Medical Writing and reporting of clinical trials. The fellow will become with writing program-level documents that are familiar with the components and structure of clinical required for approval and maintenance of marketing protocols as well as the interpretation and reporting authorization for products. These documents include of data in clinical study reports, the flow of data within global clinical and regulatory documents. This will drug development, and its meaning to stakeholders. allow the fellow to gain hands-on experience in the production of a wider variety of documents and The fellow will work closely with other areas within an understanding of their place within the drug the Global Medical Writing department and with other development process. functions in Global Development, such as Regulatory First-Year Fellows “This fellowship gives you the necessary fundamentals and experience in order to thrive and become successful in the pharmaceutical industry.”
Joseph Naggar, PharmD MCPHS University– Boston
“The Global Medical Writing Fellowship is a distinctive and challenging opportunity to integrate clinical knowledge into the industry environment. Fellows work in close collaboration with multiple departments involved in clinical development, and develop a thorough understanding of the different regulatory requirements on a global scale. This program provides a platform for professional growth within Biogen and MCPHS University thanks to remarkable preceptors and colleagues.”
Jihae Lim, PharmD Temple University School of Pharmacy
15 | Global Medical Writing Global Medical Writing | 16 Worldwide Medical Fellowship 2-YEAR PROGRAM
FUNCTIONAL GROUP ROTATIONS 12 months 12 months CORE FUNCTIONAL GROUP
About Worldwide Medical Program Directors Biogen’s Worldwide Medical (WWM) departmental For the second year of the fellowship, the fellow will “The Global Medical fellowship at Biogen provides the opportunity to gain exposure to a broad range of mission is to inform real-world medical practice pick an area of concentration to prepare them for a roles within Medical Affairs and other key functions, while also allowing the fellow to specialize in the and to optimize patient outcomes by generating, career within the pharmaceutical industry. The area of area best aligned with their personal interests and professional aspirations. This program is the perfect assimilating, and delivering clear, timely, clinically concentration must be within Worldwide Medical. catalyst for a successful career in the pharmaceutical industry.” relevant information that addresses unmet medical James Lewin, PharmD needs. We do this by providing support to Research Associate Director, Medical Communications and Development, Corporate Development, and Global Commercial Operations, and by being responsible for clinical development and research, medical “The Worldwide Medical program calls upon driven individuals to immerse themselves in the Biogen publications, biostatistics, medical education, and culture of ingenuity, passion, and excellence, contributing to the fellows’ intellectual and professional growth.” many other services. Worldwide Medical is also responsible for providing healthcare professionals, Kyle Terpak, PharmD Manager, Medical Communications regulatory agencies, and professional groups with the medical and scientific information they need to understand our company’s products. During the first year of the fellowship program, the fellow will have the opportunity to explore the different Second-Year Fellow functional areas within Worldwide Medical. If desired, the fellow will have the opportunity to select a rotation “This collaborative endeavor brought together by MCPHS and Biogen creates an impressive array of resources outside of Worldwide Medical for greater experience and learning opportunities for the aspirational industry pharmacist. The stimulating and inspired network and understanding of the biopharmaceutical industry. here provides impetus for self-discovery as well as longitudinal career growth towards the future.”
Jonathan Wang, PharmD University of Pittsburgh School of Pharmacy Fellow Select 3 Core Rotations and 1 Elective First-Year Fellows “The Worldwide Medical fellowship is a unique rotational-based program that allows fellows to explore and develop a deeper understanding of the different functional areas within Medical Affairs and the biopharmaceutical industry.”
Insights Data Generation Communication Jinny Min, PharmD University of Michigan College of Pharmacy
• Insights & Analytics • Med Communications “The Worldwide Medical fellowship provides a great opportunity for fellows to gain experience in a • Med Directors • Real-world evidence • Med Publications • Med Research wide array of functional areas within Worldwide Medical. This experience provides a solid foundation • US Medical • Med Information • US Medical for a career within the biopharmaceutical industry.” • Competitive Intelligence • Congress Planning • Real-world evidence • Medical Excellence • Med Training Melanie Standridge, PharmD Thomas Jefferson University College of Pharmacy
Electives outside of Medical available per discussion
17 | Worldwide Medical Worldwide Medical | 18 Real-World Outcomes, Innovative Partnerships, and Insights (RI2) Fellowship 2-YEAR PROGRAM
RI2 4 months PROJECT 3 months ELECTIVE 12 months 1 month MARKET ACCESS 1 month MEDICAL FUNCTION 3 months RI2
About RI2 Biogen’s Real-World Outcomes, Innovative The second year of the fellowship is dedicated to Program Directors 2 2 Partnerships, and Insights (RI ) team establishes gaining an advanced experience within the RI team. “The Real-World Outcomes, Innovative Partnerships, and Insights Fellowship provides fellows an and fosters ongoing professional relationships The fellow will complete various research initiatives, opportunity to learn key principles of pharmacoeconomics and outcomes research as well as the with key managed-market decision makers and present at congresses, partake in field medical market application of such research within the industry setting.” policymakers to provide comprehensive medical access interactions, and consistently work to be a education, collaborative research opportunities, trusted partner within the team. Mehul Jhaveri, PharmD, MPH and comparative effectiveness health outcomes Director, US Real-World Outcomes, Innovative Partnerships, and Insights solutions that seek to improve patient care within a cost-conscious and evolving healthcare environment. “Our Real-World Outcomes, Innovative Partnerships, and Insights Fellowship offering provides During the first year of the fellowship, the fellow will a unique breadth of evidence generation strategy for Payer stakeholders across all brand and obtain a working functional knowledge within the core pipeline products to transform patient lives. Future fellows will be well equipped for leadership groups with which RI2 partners. The fellow will also in an evolving healthcare market.” have an opportunity to choose a rotation outside of the core curriculum to enhance his or her experience and Eric Hall, BS, PhD Director, US Real-World Outcomes, Innovative Partnerships, and Insights understanding of the biopharmaceutical industry.
Second-Year Fellow “The Real-World Outcomes, Innovative Partnerships, and Insights Fellowship program offers a premier Elective Options opportunity to engage in meaningful discussions with US Payers. Additionally, the experienced mentorship and targeted rotational curriculum in both the Commercial and Medical books of business prime the The fellow will have the opportunity to spend up to 3 months in another department within Biogen. individual for success within the biopharmaceutical industry.” Departments may include, but are not limited to: Kun Yang, PharmD University of Maryland School of Pharmacy • Health and Economics Outcomes Research • Value Based Medicine • Pricing and Channel Distribution First-Year Fellow • Patient Services “The Real-World Outcomes, Innovative Partnerships, and Insights Fellowship provides a great opportunity to work with both internal teams and key external stakeholders by leveraging the scientific innovation of • US Medical Director’s Office our products in order to better inform value-based decisions. Furthermore, this program grants fellows • Government Policy and Advocacy the opportunity to become fully immersed across both the medical and commercial sectors in order to • Global Market Access garner the requisite experience essential for a successful career in the biopharmaceutical industry.” • Worldwide Medical Jaanai Babb, PharmD Rutgers University Ernest Mario School of Pharmacy
19 | Real-World Outcomes, Innovative Partnerships, and Insights (RI2) Real-World Outcomes, Innovative Partnerships, and Insights (RI2) | 20 Frequently Asked Questions Fellowship Alumni What is the timeline for the fellowship selection process? • Initial interviews for the fellowship are conducted at the ASHP Midyear Clinical Meeting. All candidates will Regulatory Sciences–Safety and Benefit Risk Management need to register with Personnel Placement Service (PPS) in order to interview. Alumnus/Alumna Current Position • To request an interview, select the fellowship program(s) of interest through the PPS portal and provide your contact information and a copy of your CV. Hamdan Almas, PharmD Associate Director, Oncology–US Marketing University of California–San Francisco • Applicants may submit their application materials before or after the ASHP Midyear Clinical Meeting. GILEAD Sciences, Inc. All application materials must be received by December 20th; however, applications will be accepted and School of Pharmacy reviewed prior to the due date. Due to the competitive nature of the selection process, applicants are Benjamin Exter, PharmD
encouraged to submit their application materials as soon as possible. 2007 – 2009 Director, Global Pharmacovigilance Northeastern University Takeda Pharmaceuticals International Co. • The selection process will be complete in late January. Bouvé College of Health Sciences
Do I need previous industry experience in order to be considered for the fellowship program? Raymond Kim, PharmD Associate Director, Medical Services University of California–San Francisco • No, previous industry experience is not required, but it is beneficial. Ultragenyx Pharmaceutical Inc. School of Pharmacy Do I have to be a registered pharmacist to qualify for this fellowship? James Scanlon, PharmD
• No, but licensure is strongly encouraged. To qualify for this fellowship, you must be a graduate 2008 – 2010 Medical Science Liaison of an ACPE-accredited PharmD program at the commencement of the fellowship. Northeastern University InVentiv Health Bouvé College of Health Sciences Will I be able to defer my student loans? Amy Gangadharan, PharmD • Yes, provided that the student loan company accepts fellowship deferment. Candidates should contact their Safety Scientist, Safety Risk Management lender(s) for more information regarding eligibility and terms of deferment. Northeastern University Genentech Bouvé College of Health Sciences Can I apply for more than 1 fellowship at Biogen? Stephanie Fradette, PharmD
2009 – 2011 Associate Director, Regulatory Sciences • Yes, we welcome potential applicants to explore all of the opportunities available at Biogen. Northeastern University Biogen Bouvé College of Health Sciences Is a cover letter required to request an interview at PPS? • No, a cover letter is not needed for the initial interview request, but a letter of intent is required in the Desmond Murphy, PharmD Medical Science Liason formal application. Northeastern University Biogen Bouvé College of Health Sciences Are there any other elective options available that are not listed? – 2012 2010 Kimberly Price, PharmD • All elective options are subject to availability. Additional options may be available depending on interest. Manager, Medical Information Massachusetts College of Pharmacy ARIAD Pharmaceuticals and Health Sciences–Worcester 2012 – 2014 2012
Lauren Oliva, PharmD Manager, Regulatory Sciences Rutgers University Biogen Ernest Mario School of Pharmacy 2013 – 2015 2013
Theresa Foster, PharmD Pharmacovigilance Scientist, University of New England Safety & Benefit-Risk Management College of Pharmacy Biogen
Martin Kwok, PharmD 2014 – 2016 2014 Manager, Regulatory Affairs The Ohio State University Ironwood Pharmaceuticals College of Pharmacy
21 | Frequently Asked Questions Fellowship Alumni | 22 23 2013 – 2015 2012 – 2014
| Fellowship Alumni Philadelphia CollegeofPharmacy oftheSciences University Sheila Kundu, PharmD MarioSchoolofPharmacy Ernest University Rutgers Richard Lem, PharmD Regulatory Sciences–Advertising andPromotion Sciences–Advertising Regulatory Fellowship Alumni(Cont’d) Biogen andPromotion Advertising Manager, Sciences Regulatory Bayer andPromotion Advertising Assistant Director, Affairs Regulatory
2013 – 2015 2012 – 2014 School ofPharmacy ofConnecticut University Manas Prasad, PharmD Philadelphia CollegeofPharmacy oftheSciences University Jonathan Kendter, PharmD Fellowship Alumni(Cont’d) Worldwide Medical Biogen Specialist,Medical Information MedicalAffairs Amgen Specialist & Pharmacoeconomics Senior RegionalMedicalLiaison, HealthOutcomes Fellowship Alumni |
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