Biopharmaceutical Industry PharmD Fellowships Unique Fellowships, Endless Opportunities Table of Contents About Biogen these conditions. Biogen is a truly global organization, with more than 7000 employees worldwide. In addition For more than 35 years, Biogen has been helping to our headquarters in Cambridge, , we Introduction to improve the lives of people living with serious have offices in the United States, Canada, Australia, medical conditions. Since our founding in 1978, we’ve Japan, and throughout Europe. We also have a direct A Message From Al Sandrock, commercial presence in 30 countries and distribution Executive Vice President, Chief Medical Officer, produced therapies for diseases that affect hundreds Head, Development and Worldwide Medical...... 1 of thousands of people around the world. agreements in more than 60 additional countries. Working to solve difficult challenges is the foundation About Biogen...... 2 The company was founded in Zurich, Switzerland, by of both our research and our corporate responsibility. scientists who were the first to clone and express The same passion that drives our science is reflected MCPHS University Faculty Preceptors...... 3 interferon, the monoclonal antibody that led to the in our corporate citizenship, environmental sustainability, development of our first multiple sclerosis (MS) therapy, About MCPHS University...... 4 and commitment to diversity. AVONEX®. A pioneer in the biotechnology industry and About the Fellowships...... 5 one of the first biotech companies, Biogen now has the world’s leading portfolio of MS therapies. We are Led by world-class research and development, Eligibility and Application Procedure...... 5 further applying our expertise to solve some of the most challenging and complex diseases in neurology, Biogen uses novel science and leading-edge including Alzheimer’s disease, spinal muscular atrophy technologies to discover, develop, commercialize, Fellowships (SMA), Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and stroke. The pace of discovery and manufacture transformative therapies for Regulatory Sciences/Safety and Benefit-Risk Management....7 and innovation in neuroscience is accelerating patients with few or no treatment options. Dear Prospective Biogen Fellow, rapidly, bringing the promise of incredible advances to Safety and Benefit-Risk Management...... 9 Thank you for your interest in the Biogen Post-PharmD patients. As we help lead this transformative period in Regulatory Sciences–Advertising and Promotion...... 11 Programs. The evolving and growing world of biopharmaceutical neuroscience, Biogen is driving a deeper understanding industry has opened up a tremendous amount of opportunity for of disease biology and working to develop potentially Regulatory Sciences–Trial Master File/Clinical pharmacists looking for an alternative and diverse career path. life-changing treatments for the people suffering from 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 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...... 6 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 pursuing science that truly matters. Best of luck as you explore the different opportunities available to you, and I strongly encourage you to consider the Biogen Fellowship.

Sincerely,

Al Sandrock, MD, PhD Executive Vice President, Chief Medical Officer, Head, Development and Worldwide Medical

About Biogen | 2 MCPHS University Faculty Preceptors About MCPHS University Lynn Squillace, JD, MPH Catherine Taglieri, BSP, Director of Regulatory Sciences PharmD, RPh MCPHS University provides an academic environment to guide and support fellows toward a successful career & Health Policy Assistant Professor of in the biopharmaceutical industry. As a private institution with a history of specializing in the health sciences, Assistant Professor Pharmacy Practice MCPHS University offers programs that embody scholarship, professional service, and community outreach. 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. Michael Steinberg, BA, BS, Stefanie Nigro, PharmD, • co-precept students on advanced experiential rotations. PharmD, BCOP BCACP, BC-ADM Professor of Pharmacy Practice Assistant Professor • create and publish scholarly research and review articles. • present data at scientific and clinical meetings. • participate in professional development seminars.

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 Amee Mistry, PharmD Pharmaceutical Business and Associate Professor of Administrative Sciences Pharmacy Practice

Paul Kaplita, PhD Timothy Aungst, PharmD Associate Professor of Assistant Professor of Pharmaceutical Sciences Pharmacy Practice

3 | MCPHS University Faculty Preceptors About MCPHS University | 4 About the Fellowships Frequently Asked Questions Biogen, in collaboration with MCPHS University, offers 7 unique fellowship programs to promote the role of What is the timeline for the fellowship selection process? Doctor of Pharmacy (PharmD) within the biopharmaceutical industry: • Initial interviews for the fellowship are conducted at the ASHP Midyear Clinical Meeting. All candidates will • Regulatory Sciences/Safety and Benefit-Risk Management (Reg/SABR) need to register with Personnel Placement Service (PPS) in order to interview. • Safety and Benefit-Risk Management (SABR) • 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. • Regulatory Sciences–Advertising and Promotion (Reg–AP) • Applicants may submit their application materials before or after the ASHP Midyear Clinical Meeting. • Regulatory Sciences–Trial Master File/Clinical Trial Application (Reg–TMF/CTA) All application materials must be received by December 20th; however, applications will be accepted and • Global Medical Writing (GMW) reviewed prior to the due date. Due to the competitive nature of the selection process, applicants are encouraged to submit their application materials as soon as possible. • Worldwide Medical (WWM) • The selection process will be complete in late January. • Real-World Outcomes, Innovative Partnerships, and Insights (RI2) Fellows will gain extensive experience through a variety of practical activities in both industry and academic Do I need previous industry experience in order to be considered for the fellowship program? settings, which will enhance the potential for accelerated career development. • No, previous industry experience is not required, but it is beneficial.

Do I have to be a registered pharmacist to qualify for this fellowship? Eligibility • No, but licensure is strongly encouraged. To qualify for this fellowship, you must be a graduate of an ACPE-accredited PharmD program at the commencement of the fellowship. • Applicants must hold a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy by the commencement of the program. Will I be able to defer my student loans? • Candidates must have excellent written and oral (ie, verbal) communication skills and a strong interest in • Yes, provided that the student loan company accepts fellowship deferment. Candidates should contact their pursuing a career within the biopharmaceutical industry. lender(s) for more information regarding eligibility and terms of deferment. • The Biogen fellows will be selected on a nationally competitive basis. Can I apply for more than 1 fellowship at Biogen? • All fellowships last 2 years with a start date of July 1st. • Yes, we welcome potential applicants to explore all of the opportunities available at Biogen.

Application Procedure Is a cover letter required to request an interview at PPS? • Candidates are encouraged to request a preliminary interview at the American Society of Health-System • No, a cover letter is not needed for the initial interview request, but a letter of intent is required in the Pharmacists (ASHP) midyear meeting through the Personal Placement Service (PPS) website. formal application. • Interested candidates must submit their application materials online at Are there any other elective options available that are not listed? http://www.mcphs.edu/BiopharmaceuticalFellowships, by December 20th. • All elective options are subject to availability. Additional options may be available depending on interest. – Please submit a letter of intent, curriculum vitae, three references with contact information, and unofficial college transcript(s).

5 | About the Fellowships Frequently Asked Questions | 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 SABR/Regulatory Fellowship provides been a source of incredibly talented Regulatory Sciences is a well-integrated global the opportunity for Fellows to gain a well- and inspiring individuals who have department that provides worldwide strategic contributed to the recognition of the Biogen is responsible for the continuous assessment rounded experience through exposure regulatory guidance and operational support for programs throughout the company.” of the benefit-risk relationship of all of its products— and practical experience across multiple Biogen’s development and commercial programs. starting in the early stages of development and functions. They become integral members of Stacie Knight The fellow will acquire a better understanding of our teams.” continuing through the postmarketing phase. Members Director, Regulatory Sciences the dynamics of the drug development process of the SABR department are continuously working to Sharon Chan, PharmD throughout the life cycle of our products, from early gain a better understanding of the safety profile of Senior Manager, SABR 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 will have the opportunity to gain experience in the data necessary to make an informed decision “The partnership between MCPHS and Biogen provides a challenging yet nurturing environment for different functions of the regulatory department, regarding disease management. which are as follows. fellows to be fully immersed in high-profile projects, driving personal and professional growth through During the rotation in SABR, the fellow will have an guidance from an impressive network of experienced individuals within the biopharmaceutical industry.” • Advertising and Promotion (AP) opportunity to rotate through 3 general areas: Kathy Lu, PharmD • Operations • Global Case Management University of the Sciences Philadelphia College of Pharmacy • Labeling • Pharmacovigilance (PV) Scientists • Clinical Trial Applications (CTA) • Epidemiology “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 Fellowship Contact Information projects that foster professional and personal growth.” [email protected] Tina Chhabra, PharmD Virginia Commonwealth University School of Pharmacy

Elective Options First-Year Fellows

The fellow will have the opportunity to spend up to “The Regulatory Sciences/Safety and Benefit-Risk Management fellowship offers the opportunity 4 months in another department within Biogen. to work closely with accomplished professionals on meaningful projects, which impact challenging Departments may include, but are not limited to: and complex diseases. Through this program, the fellow will acquire the skills needed to excel in the biopharmaceutical industry.” • Clinical Drug Supply Chain • Global Clinical Operations Brianne Fitzgerald, PharmD MCPHS University - • Global Commercial Strategy • Health Economics and Outcomes Research “The Regulatory Sciences and Safety & Benefit-Risk Management fellowship at Biogen uniquely allows the fellow to gain substantial exposure to two closely related functional areas and develop the skills • Marketing necessary for a successful transition to a career in the biopharmaceutical industry.” Also, the fellow will have the opportunity to precept PharmD students. Amanda Hall, PharmD Temple 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

GLOBAL CASE MANAGEMENT 4 months PHARMACOVIGILANCE/ EPIDEMIOLOGY 10 months ELECTIVE 10 months

About Safety and Program Director Benefit-Risk Management “The SABR Fellowship allows the Fellow to learn and contribute to the pharmacovigilance lifecycle through rotations across the various sub-functions. They become integral members of our teams.” Biogen is responsible for the continuous assessment Global Case Management: During this rotation, the of the benefit-risk relationship of all of its products— fellow will become knowledgeable about the adverse Sharon Chan, PharmD starting in the early stages of development and event reporting process including initial review Senior Manager, SABR continuing through the postmarketing phase. Members and triage, adverse event report assessment, and of the Safety and Benefit-Risk Management department distribution rules. The fellow will also enhance his or her are continuously working to gain a better understanding understanding of clinical trial safety, ICSR reporting, global of the safety profile of marketed products and those in pharmacovigilance regulations and guidelines, safety development in order to provide the medical community data exchange agreements, and vendor oversight. First-Year Fellow and patients with the data necessary to make an informed decision regarding disease management. Epidemiology: During this rotation, the fellow will work “As a first year fellow at Biogen, I feel fortunate to have the opportunity to be directly involved in closely with epidemiologists to provide REMS support, various cross-functional projects. The team within SABR is fully supportive of the fellowship and This 2-year Safety and Benefit-Risk fellowship is understand and evaluate real-world data, and prepare is invested in our professional development. I look forward to the continued professional growth designed to provide an in-depth and hands-on epidemiology-based product summaries experience. Starting from individual case safety reports throughout the program, which will prepare me for a successful career in the biopharmaceutical through aggregate reporting the fellow will learn about Pharmacovigilance (PV) Scientists: During this industry.” the pharmacovigilance life cycle. Through this program, rotation, the fellow will engage in safety surveillance activities and prepare and review signal evaluations, Michael Ryan, PharmD the fellow will gain exposure to the following three MCPHS University - Boston general areas: periodic safety update reports, and risk management plans utilizing the training and skills gained through previous rotations. Fellowship Contact Information [email protected]

Elective Options The fellow will have the opportunity to spend up to 4 months in another department within Biogen. Departments may include, but are not limited to: • Regulatory Sciences • Global Medical Writing • Clinical Drug Supply Chain • Global Clinical Operations • Global Commercial Strategy • Health Economics and Outcomes Research Also, the fellow will have the opportunity to precent PharmD students.

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 program provides individuals interested in the regulatory sciences with a unique opportunity is one of the functional groups within the Regulatory be obtained solely from a professional degree; instead, to work in the constantly evolving field of advertising and promotion. Our well-structured fellowship Sciences organization that support Biogen’s the necessary knowledge is gained predominantly allows for the opportunity to work on cross-functional teams, gain hands-on regulatory experience, development and commercial programs. The Regulatory through on-the-job training and hands-on experience. and participate in rotations in both marketing and an elective of their choice. These opportunities, Sciences–AP team is responsible for providing along with a core foundation in advertising and promotion, provide a well-rounded experience that Biogen recognizes this critical need for experienced Biogen with strategic, high-quality, timely, and decisive allows our fellows to be competitive within the biopharmaceutical industry.” Regulatory Sciences–AP professionals and has regulatory advice on advertising and promotional partnered with the marketing department to offer a materials, communications, and company activities in Blythe Buchanan accordance with FDA regulations, company policies, and fellowship with opportunities to experience and learn Director, Regulatory Sciences business goals. The AP group leads communications the following: with regulatory agencies related to US labeling, • the FDA regulations that govern advertising, First-Year Fellow advertising, and promotion. and promotion “This fellowship program is an excellent opportunity to work closely with a team of passionate and This 2-year Regulatory Sciences–AP fellowship is • how to accurately and effectively apply regulations experienced regulatory science professionals in the setting of advertising and promotion. The leadership designed to provide advanced, hands-on experience. and provide guidance within the advertising and promotion team has been amazing; with their direction and support I was The fellowship provides AP professionals with • how promotional materials are developed through able to quickly become a valuable, contributing member of the team. I am surrounded by a great group comprehensive knowledge of regulations and the commercial organization of mentors, who are devoted to seeing me grow personally and professionally, and I am confident that real-world applications for advertising and promotion the unique opportunities provided to me during this fellowship will help me to be successful in the in the biopharmaceutical industry. The overall goal of the program is to prepare each fellow to be a successful Regulatory Sciences–AP professional biopharmaceutical industry.” with a solid understanding of how FDA regulations are Kathleen Neumann, PharmD followed by the biopharmaceutical industry and enforced MCPHS University - Boston Fellowship Contact Information by the FDA. Upon completion of the fellowship, the [email protected] experienced fellow will be well-prepared to enter into an advanced career in Regulatory Sciences–AP.

Elective Options 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 “The Biogen fellowship programs have been a source of incredibly talented and inspiring individuals File (TMF) and Clinical Trial Application (CTA). Over the experience within the CTA team, which is responsible who have contributed to the recognition of the programs throughout the company. course of 2 years, the fellow will be a member of cross- for managing international clinical trial applications with functional teams and work with key individuals that have health authorities. In doing so, the team is responsible Stacie Knight Director, Regulatory Sciences 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 Maintenance of the accurate and appropriate documentation timely execution of the application submissions. 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, “The TMF/CTA Regulatory fellowship offers a great opportunity for learning about the composition of Practices (GCP) compliance. The fellow will also have the the fellow will support the CTA lead with startup, the clinical trial master file and experience in execution of global clinical trial applications. Fellows opportunity to complete collaborative initiatives within maintenance, and close-out activities for various will be exposed to a broad insight of regulatory processes on a global level and develop a thorough Regulatory Sciences. studies. The team provides regulatory training and understanding of regulatory affairs within clinical trials.” education to increase the fellow’s exposure to multiple The TMF is considered the autobiography of a study and aspects of Regulatory Sciences. Matt Stagray is our evidence that the integrity of the trial data, study Senior Manager, Regulatory Sciences analysis, and study conclusions are credible, and that patient rights and safety have been protected. During the first year of the fellowship, the fellow will obtain a Fellowship Contact Information functional working knowledge within the TMF group as [email protected] a support system for the TMF Study Owners, Manager, Second-Year Fellow and Process Owner. The team provides comprehensive “I feel incredibly grateful to work in an environment where the culture is collaborative, not competitive. collaborative opportunities with TMF partners such The TMF & CTA team at Biogen provides a great opportunity for professional and personal growth, as as Global Clinical Operations, Safety and Benefit Risk well as multiple teaching opportunities with MCPHS. As valued members of this multidisciplinary team, Management, and Records Management. This provides fellows gain increased exposure to the world of industry and regulatory sciences, and acquire an in-depth the foundation for the second year of the fellowship. knowledge of the submission and compliance process on a global scale.”

April Nguyen, PharmD Elective Options University of the Pacific Thomas J. Long School of Pharmacy & Health Sciences The fellow will have the opportunity to spend up to First-Year Fellow 3 months in another department within Biogen. “The TMF/CTA fellowship provides a unique opportunity to really understand and take ownership of Departments may include, but are not limited to: regulatory responsibilities, including the structure and maintenance of the Trial Master File. While working with core team members I feel supported and encouraged to learn and grow as much as possible during • Worldwide Medical my time as a fellow.” • Global Commercial Strategy Olivia Weiss, PharmD • Health Economics and Outcomes Research Notre Dame of Maryland University, School of Pharmacy • 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 Regulatory Sciences - Global Medical Writing Fellowship 2-YEAR PROGRAM

GLOBAL MEDICAL WRITING 4 months GLOBAL MEDICAL WRITING 10 months ELECTIVE 10 months

About Global Medical Writing Biogen’s Medical Writing Fellowship will focus on The fellow will also become familiar in the Program Directors “The medical writing fellowship clinical and regulatory documents needed for drug interpretation and reporting of the clinical data, program offers a unique “Medical Writing offers a great development. Over the course of 2 years, the fellow the purpose of the clinical study report, and opportunity to gain knowledge on vantage point to be involved in will work with teams including physicians, statisticians, the importance of the data in this document to clinical development through the clinical pharmacologists, and other scientists to create stakeholders. a wide range of activities that preparation of clinical and regulatory the documents needed to support the conduct and support drug development.” documents.” Working within cross-functional teams provides reporting of clinical trials, as well as the documents Mark Fielding, PhD needed to obtain and maintain marketing authorization exposure to the different scientific and medical Begona Ruiz Perez, PhD Director, Medical Writing Associate Director, Medical Writing for therapies. functions within drug development and in how they collaborate on clinical studies. Also, developing an ​​​​​In the first year, the fellow will develop documents at understanding of how the study-level documents are the level of an individual clinical study of a potential created will provide the fellow with the foundation Second-Year Fellows new drug. These documents will include the clinical needed to understand how individual studies support “The Global Medical Writing Fellowship offers you the opportunity to work alongside the brightest minds study protocol and the clinical study report needed the overall drug development process. in drug development. This program equips you with the experience necessary to lead teams through to conduct and describe the data from the study, regulatory document lifecycles and contribute to the development of life saving therapies.” respectively. The fellow, as part of the cross-functional In the second year, the fellow will work on program- team of scientists and physicians, will learn about level documents that are required to support all Joseph Naggar, PharmD the purpose, structure and components of a protocol, studies within a drug development program, or support MCPHS University– Boston and the process required to develop and adapt the the submission of data to regulatory authorities for protocol during the course of a study. marketing authorizations. This will allow the fellow to gain experience with a wider variety of documents and an understanding of their function within the broader “The Global Medical Writing Fellowship is a distinctive and challenging opportunity to integrate clinical context of drug development.” knowledge into the industry environment. Fellows work in close collaboration with multiple departments Fellowship Contact Information involved in clinical development, and develop a thorough understanding of the different regulatory [email protected] 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 Elective Options Temple University School of Pharmacy The fellow will have the opportunity to spend up to 4 months in another department within Biogen. Departments may include, but are not limited to: First-Year Fellow “The Global Medical Writing fellowship provides unique opportunities to become involved in the drug •  Global Clinical Operations development process at Biogen. Fellows are exposed to a wide variety of projects and collaborate • Regulatory Sciences with multiple departments across the company to develop both clinical and regulatory documents. • Safety and Benefit-Risk Management This fellowship program will build a strong foundation for any pharmacist aspiring to work in the biopharmaceutical industry.” • Scientific Communications Melissa Laracy, PharmD • Worldwide Medical University of Connecticut 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 “The Worldwide Medical program calls upon driven individuals to immerse Biogen’s Worldwide Medical (WWM) departmental For the second year of the fellowship, the fellow will “The Worldwide Medical fellowship at themselves in the Biogen culture of mission is to inform real-world medical practice pick an area of concentration to prepare them for a Biogen provides the opportunity to gain and to optimize patient outcomes by generating, career within the biopharmaceutical industry. The area exposure to a broad range of roles within ingenuity, passion, and excellence, assimilating, and delivering clear, timely, clinically of concentration must be within Worldwide Medical. Medical Affairs, while also allowing the contributing to the fellows’ intellectual relevant information that addresses unmet medical fellow to specialize in the area best and professional growth.” aligned with their personal interests and needs. We do this by providing support to Research professional aspirations.” Kyle Terpak, PharmD and Development, Corporate Development, and Senior Manager, Global Scientific Commercial, and by leading phase 4 studies James Lewin, PharmD Communications and real-world data generation efforts, scientific Associate Director, Global Scientific communications, medical education, medical Communications information, and many other responsibilities. Worldwide Medical is also responsible for providing Second-Year Fellows healthcare professionals, regulatory agencies, “The Worldwide Medical fellowship is a unique rotational-based program that allows fellows to professional groups, and patients with the medical explore and develop a deeper understanding of the different functional areas within Medical Affairs and scientific information they need to understand our and the biopharmaceutical industry.” company’s products. Jinny Min, PharmD During the first year of the fellowship program, University of Michigan College of Pharmacy the fellow will have the opportunity to explore the different functional areas within Worldwide Medical. If desired, the fellow will have the opportunity to “The Worldwide Medical fellowship provides a great opportunity for fellows to gain experience in a select a rotation outside of Worldwide Medical to Fellowship Contact Information wide array of functional areas within Worldwide Medical. This experience provides a solid foundation for a career within the biopharmaceutical industry.” obtain a unique perspective and understanding of the [email protected] biopharmaceutical industry. Melanie Standridge, PharmD Thomas Jefferson University College of Pharmacy

First-Year Fellows “The accomplished Worldwide Medical team ensures that fellows take ownership of impactful projects across various functional areas in order to lay the foundation for a meaningful career in the biopharmaceutical industry.”

Tyler Lasky, PharmD Butler University, College of Pharmacy & Health Sciences

“From preceptors who care about your professional growth, to a flexible rotation-based structure, the Worldwide Medical Fellowship fuses together multiple elements to provide fellows with a truly unique opportunity.”

Anthony Zaki, PharmD , School of Pharmacy

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 his or her experience and understanding of the Program Directors 2 Partnerships, and Insights (RI ) team seeks to biopharmaceutical industry (e.g. Medical Information, “The Real-World Outcomes, Innovative Partnerships, and Insights Fellowship provides fellows an evolve patient care within a cost-conscious and Market Access & Reimbursement, US or Global opportunity to learn key principles of pharmacoeconomics and outcomes research and its applications to changing healthcare environment in the US. Through Medical Directors, Publications and Communications, patients, physicians, payers, and healthcare policy-makers.” collaborative real-world outcomes research and health and Regulatory, etc.) economics studies (e.g., retrospective analyses, Mehul Jhaveri, PharmD, MPH 2 prospective observational studies, comparative The second year of the RI fellowship is dedicated to Director, US Real-World Outcomes, Innovative Partnerships, and Insights effectiveness research, qualitative patient quality developing essential leadership skills and advancing of life research), the team develops evidence-based competencies to enable strategic execution of 2 outcomes and tools to educate the medical, payer, projects and business activities. The RI fellow will “Our fellowship prepares business-minded professionals so they can successfully connect, inspire, patient, and health policy communities on the value of be the lead for research projects, present scientific and challenge the healthcare community to deliver better patient outcomes.” the Biogen portfolio. research at clinical congresses or key business meetings, and participate in strategic business Michelle Patel Senior Manager, US Real-World Outcomes, Innovative Partnerships, and Insights During the first year of the fellowship, the fellow planning efforts within the organization. will obtain a working knowledge of key principles 2 that enable the design and delivery of meaningful By the end of the fellowship, the RI Fellow will have real-world research while building relationships with a solid foundation to pursue various roles within cross-functional colleagues. The fellow will have an Medical Affairs and Health Economics and Outcomes opportunity to choose from multiple rotations outside Research. 2 of the core RI curriculum to enhance and broaden RI2 will not be recruiting for the 2017-2018 Second-Year Fellow Fellowship Contact Information fellowship year. [email protected] “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 our products in order to better inform value-based decisions. Furthermore, this program grants fellows the opportunity to become fully immersed across both the medical and commercial sectors in order to Elective Options garner the requisite experience essential for a successful career in the biopharmaceutical industry.”

The fellow will have the opportunity to spend up to Jaanai Babb, PharmD 3 months in another department within Biogen. Rutgers University Ernest Mario School of Pharmacy Departments may include, but are not limited to: • Health and Economics Outcomes Research First-Year Fellow • Value Based Medicine “The Real World Outcomes, Innovative Partnerships and Insights Fellowship program enables fellows • Pricing and Channel Distribution to develop a diverse skillset spanning both medical and commercial functional areas. By engaging • Patient Services in meaningful research and outcomes based initiatives, fellows gain the tools necessary to become successful leaders in the biopharmaceutical industry.” • US Medical Director’s Office • Government Policy and Advocacy Alysa Redlich, PharmD, MBA University of Rhode Island • Global Market Access • Worldwide Medical

19 | Real-World Outcomes, Innovative Partnerships, and Insights (RI2) Real-World Outcomes, Innovative Partnerships, and Insights (RI2) | 20 Fellowship Alumni Fellowship Alumni (Cont’d)

Regulatory Sciences–Safety and Benefit Risk Management Regulatory Sciences-Safety and Benefit Risk Management Alumnus/Alumna Current Position Colin Gillis, PharmD Manager, Global Regulatory Strategy Northeastern University Biogen Hamdan Almas, PharmD Director, Oncology–US Marketing Bouve College of Health Sciences University of California–San Francisco GILEAD Sciences, Inc. School of Pharmacy Bhumi Patel, PharmD 2015 – 2017 2015 Manager, Regulatory Global Labeling Rutgers University Benjamin Exter, PharmD Pfizer 2007 – 2009 Senior Director, Clinical Sciences Ernest Mario School of Pharmacy Northeastern University Unum Therapeutics Bouvé College of Health Sciences Regulatory Sciences- Advertising and Promotion

Raymond Kim, PharmD Associate Director, Medical Services Richard Lem, PharmD Associate Director, Regulatory Affairs University of California–San Francisco Ultragenyx Pharmaceutical Inc. Rutgers University Advertising and Promotion School of Pharmacy Ernest Mario School of Pharmacy Bayer 2012 – 2014 2012 James Scanlon, PharmD

2008 – 2010 Regional Medical Liaison Sheila Kundu, PharmD Manager, Regulatory Sciences Northeastern University Amgen University of the Sciences Advertising and Promotion Bouvé College of Health Sciences Philadelphia College of Pharmacy Biogen 2013 – 2015 2013 Amy Gangadharan, PharmD Sr. Safety Scientist, Safety Risk Management Manager, Regulatory Affairs Northeastern University Kate Ho, PharmD Genentech Advertising and Promotion Bouvé College of Health Sciences Purdue University College of Pharmacy TESARO, Inc 2015 – 2017 2015 Stephanie Fradette, PharmD

2009 – 2011 Associate Director, Regulatory Sciences Worldwide Medical Northeastern University Biogen Bouvé College of Health Sciences Jonathan Kendter, PharmD Senior Regional Medical Liaison, Health Outcomes University of the Sciences & Pharmacoeconomics Specialist Desmond Murphy, PharmD Medical Science Liason Philadelphia College of Pharmacy Amgen 2012 – 2014 2012 Northeastern University Biogen Bouvé College of Health Sciences

2010 – 2012 2010 Manas Prasad, PharmD Medical Information Specialist, Medical Affairs University of Connecticut Kimberly Price, PharmD Biogen Senior Manager, Scientific Communications School of Pharmacy Massachusetts College of Pharmacy – 2015 2013 bluebird bio and Health Sciences–Worcester 2012 – 2014 2012

Lauren Oliva, PharmD Senior Manager, Regulatory Sciences Rutgers University Biogen Ernest Mario School of Pharmacy 2013 – 2015 2013

Theresa Foster, PharmD Pharmacovigilance Scientist, University of New England AstraZeneca College of Pharmacy

Martin Kwok, PharmD 2014 – 2016 2014 Senior Manager, Regulatory Affairs The Ohio State University Ironwood Pharmaceuticals College of Pharmacy

21 | Fellowship Alumni Fellowship Alumni | 22