biopharmaceutical industry pharmd fellowships - biogen

Biopharmaceutical Industry PharmD FellowshipsUnique Fellowships, Endless Opportunities

Introduction

A Message From Al Sandrock, Chief Medical Officer ..........1

About Biogen ..................................................................2

About the Fellowships .....................................................3

Eligibility and Application Procedure..................................4

Fellowships

Regulatory Affairs – Safety and Benefit-Risk Management ...5

Regulatory Affairs – Advertising, Labeling, and Promotion ....7

Worldwide Medical........................................................9

Medical and Value Based Outcomes ............................11

Program Information

Fellowship Alumni .......................................................13

Frequently Asked Questions ........................................14

Table of Contents

Thank you for your interest in the Biogen™ Post-PharmD Fellowship Programs. The evolving and growing world of the biopharmaceutical industry has opened up a tremendous number of opportunities for pharmacists looking for an alternative and diverse career path. Since the start of this fellowship, Biogen, in collaboration with MCPHS University, has trained and promoted the role of the Doctor of Pharmacy within the company, academia, and the industry as a whole. Fellows completing this program not only grow professionally in terms of skills and expertise but also make substantial impact on programs integral to the success of Biogen.

Focused on developing and delivering therapies for neurodegenerative, hematologic, and autoimmune disorders, Biogen is one of the oldest independent biotechnology companies in the world. We provide a culture of innovation, inclusiveness, and empowerment. This environment provides for personal and professional growth—all while creating an atmosphere of learning and new opportunities for our employees. Our passion and focus are 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.

This is 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 Group Senior Vice President and Chief Medical Officer

About Biogen | 2

“The Worldwide Medical fellowship provides fellows the opportunity to expand their horizons; it challenges them to learn new concepts in the research, development, and commercial areas and fosters growth of the leadership competencies needed for the dynamic biopharmaceutical landscape.”

Amit Rakhit, MD Senior Vice PresidentWorldwide Medical

“In the innovative and ever-changing world of drug safety and risk management, we are committed to providing challenging experiences that build a depth of knowledge and foster the potential for accelerated professional development.”

Priya Singhal, MD, MPHVice President, Global HeadSafety and Benefit-Risk Management

“Our program represents a unique opportunity to develop people in the rapidly evolving global regulatory environment, impacting healthcare and public health policy.”

Nadine Cohen, PhDSenior Vice President, Global HeadRegulatory Affairs

About BiogenBiogen is one of the world’s leading biotechnology companies, with a focus on developing therapies for neurodegenerative, hematologic, and autoimmune disorders. Founded in 1978, our work in biologics and small-molecule drug discovery has led to the world’s most extensive portfolio of multiple sclerosis therapies and innovative new treatments for hemophilia patients. Our experience, capabilities, and passion for innovation have enabled us to build a pipeline and to develop advanced research programs that include exploration of potential candidates for serious and difficult-to-treat neurodegenerative diseases and fibrotic and nonmalignant blood disorders.

We are committed to research that uncovers the underlying biology of complex diseases. Our focus is on illnesses that have few, if any, treatment options. Biogen’s success will always be measured by the answer to a simple question: Have we truly made a difference in the lives of patients?

The history of Biogen is the story of a passionate commitment to discover, develop, and deliver important new therapies to patients.

Eligibility and Application Procedure | 43 | About the Fellowships

About the FellowshipsBiogen, in collaboration with MCPHS University, offers 4 unique fellowship programs to promote the role of Doctor of Pharmacy (PharmD) within the biopharmaceutical industry:

• Regulatory Affairs/Safety and Benefit-Risk Management (Reg/SABR)

• Regulatory Affairs – Advertising, Labeling, and Promotion (Reg – ALP)

• Worldwide Medical (WWM)

• Medical and Value Based Outcomes (MVBO)

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.

About MCPHS UniversityMCPHS University provides an academic environment to guide and support fellows toward a successful career in the biopharmaceutical industry. As a private institution with a history of specializing in health sciences, 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

• Co-precept students on advanced experiential rotations

• Create and publish scholarly research and review articles

• Present data at scientific and clinical meetings

• Participate in professional development seminars

MCPHS University Faculty Preceptors

“Fellows come into the program with a lot of energy and intelligence, and I’m glad I can play a role in helping them further develop their talents and ultimately reach their goals.”

“We strive to ensure that the unique opportunities that the partnership between MCPHS University and Biogen offers are beneficial to the continuous professional development of our fellows.”

Michael Steinberg, BA, BS, PharmD, BCOP Associate Professor of Pharmacy Practice

“I can best describe the partnership between Biogen and MCPHS as synergistic—our combined efforts are greater than the sum of our individual works.”

“I have seen the advantages of having a fellowship experience over my many years in the industry. It both opens doors and provides the foundations to greatly assist fellows in better choosing and advancing their careers.”

Kristine Willett, BS, PharmD Associate Professor of Pharmacy Practice

Brian Rittenhouse, MS, PhDAssociate Professor of Pharmacy Practice

Eligibility• Fellows will be selected on a nationally competitive basis, with interviews at the

American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting

• Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy

• Candidates must have strong written and verbal communication skills and an interest in pursuing a career in the biopharmaceutical industry

• All candidates must have authorization to work in the United States throughout the duration of the 2-year fellowship; no visa sponsorship will be provided

Application Procedure• Candidates are encouraged to request a preliminary interview at the ASHP

midyear meeting through the Personal Placement Service (PPS) website.

• Interested individuals must apply on-line at the MCPHS portal at www.mcphs.edu/jobs once positions are posted starting November 1st through January 2nd. Please submit a cover letter, curriculum vitae, unofficial transcripts, and names and contact information of 3 references.

• After the applications are reviewed, the final candidates will receive a request from the respective Biogen program to electronically submit a letter of intent and 3 letters of recommendation to the program’s appropriate email address. Also at this time, the final candidates will be required to submit an official transcript to the appropriate program’s mailing address below.

Reg/SABR Reg – ALP WWM MVBO

Duration 2 Years 2 Years 2 Years 2 Years

Position 2 1 1 1

Start Date July 1 July 1 July 1 July 1

Reg/SABR Reg – ALP WWM MVBO

Program Design

EmailRegSafetyFellowship

@biogen.com

Stacie Knight,Regulatory Affairs

Biogen300 Binney Street

Cambridge, MA 02142

Heather Abourjaily, PharmD

Worldwide Medical

Biogen225 Binney Street

Cambridge, MA 02142

Richard Lem, PharmD

Regulatory Affairs – ALP

Biogen133 Boston Post Road

Weston, MA 02493

Jon Kendter, PharmD

US Medical

Biogen133 Boston Post Road

Weston, MA 02493

[email protected]

[email protected]

[email protected]

Mailing Address

Application Information

Courtney Jarvis, PharmD Associate Professor and Vice Chair, Pharmacy Practice

Elective OptionsThe fellow will have the opportunity to spend up to 4 months in another department within Biogen.

Departments may include, but are not limited to:

• Clinical Drug Supply Chain

• Global Clinical Operations

• Global Commercial Strategy

• Health Economics and Outcomes Research

• Marketing

Also, the fellow will have the opportunity to precept PharmD students.

Regulatory Affairs/Safety and Benefit-Risk Management | 65 | Regulatory Affairs/Safety and Benefit-Risk Management

Regulatory AffairsRegulatory Affairs is a well-integrated global department that provides worldwide strategic regulatory guidance and operational support for Biogen’s development and commercial programs. The fellow will acquire a better understanding of the dynamics of the drug development process throughout the lifecycle of our products, from early development through approval and commercialization.

During the rotation in Regulatory Development, the fellow will have the opportunity to gain experience in the different functional groups of the regulatory department.

• Chemistry, Manufacturing, and Controls (CMC)

• Advertising, Labeling, and Promotion (ALP)

• Operations

• Global Labeling

• Clinical Trial Applications (CTA)

• R and D Compliance

Safety and Benefit-Risk Management (SABR)Biogen is responsible for the continuous assessment of the benefit-risk relationship of all of its products— starting in the early stages of development throughout the postmarketing phase. Members of the Safety and Benefit-Risk Management department are continuously working to gain better understanding of the safety profile of marketed products and those in development in order to provide the medical community and patients with the necessary data to make an informed decision regarding disease management.

During the rotation in SABR, the fellow will have an opportunity to rotate through 3 general areas:

• Global Case Management

• Pharmacovigilance (PV) Scientists

• Epidemiology

“The success of our program is a tribute to highly motivated fellows, coupled with an exceptionally supportive environment throughout the company.”

Mehdi Chakir, PharmD Associate Director, SABR

“The Biogen fellowship programs have been a source of incredibly talented and inspiring individuals who have contributed to the recognition of the programs throughout the company.”

Stacie Knight Director, Regulatory Affairs

“The fellowship program provides a platform both to engage with multiple aspects of the biopharmaceutical industry and to build valuable relationships with a variety of experienced professionals.”

Theresa Foster, PharmDUniversity of New England, College of Pharmacy

“This program offers fellows an unparalleled experience to learn from extremely motivated and experienced professionals and participate in high-visibility projects during a very exciting and innovative time in the biopharmaceutical industry.”

Martin Kwok, PharmDThe Ohio State University, College of Pharmacy

“This fellowship provides an unrivaled opportunity to learn from a diverse group of individuals from countless backgrounds and disciplines in the biopharmaceutical industry—all while growing professionally and becoming deeply involved in meaningful and important projects.”

Colin Gillis, PharmDNortheastern University

“This program is a unique opportunity for fellows to gain extensive practical experience in an invigorating environment and foster the skills necessary for success in the biopharmaceutical industry.”

Bhumi Patel, PharmDUniversity of the Sciences, Philadelphia College of Pharmacy

Program Directors

Second-Year Fellows

First-Year Fellows

Regulatory Affairs/Safety and Benefit-Risk Management Fellowship

REGULATORY AFFAIRS

10 months 10 months

4 months

ELECTIVE

SAFETY AND BENEFIT-RISK MANAGEMENT

2-YEAR PROGRAM



• Worldwide Medical

• Global Commercial Strategy

• Health Economics and Outcomes Research

• Safety and Benefit-Risk Management

• Regulatory Development

Also, the fellow will have the opportunity to precept PharmD students.

Regulatory Affairs – Advertising, Labeling, and Promotion | 87 | Regulatory Affairs – Advertising, Labeling, and Promotion

“The fellowship program is an opportunity to build a solid foundation of regulatory knowledge and brand strategy that will prove to be invaluable for their careers.”

Richard Lem, PharmDManager, Regulatory Affairs – ALP

Program Director

“This fellowship program offers the opportunity to work and engage with experienced and motivated individuals to gain valuable, hands-on regulatory experience. Through this unique opportunity, the fellow will gain the necessary skills and network to be successful in the biopharmaceutical industry.”

Sui Kate Ho, PharmDPurdue University

First-Year Fellow

About Reg – ALPRegulatory Affairs – Advertising, Labeling, and Promotion (ALP) is one of the functional groups within the Regulatory Affairs organization that support Biogen’s development and commercial programs. The Regulatory Affairs – ALP team is responsible for providing Biogen with strategic, high-quality, timely, and decisive regulatory advice on advertising and promotional materials, communications, and company activities in accordance with FDA regulations, company policies, and business goals. Also, this team is responsible for the creation, revision, and maintenance of US product labeling. The ALP group leads communications with regulatory agencies related to US labeling, advertising, and promotion.

This 2-year Regulatory Affairs – ALP fellowship is designed to provide advanced hands-on experience. The fellowship develops Regulatory Affairs – ALP professionals with comprehensive knowledge of advertising and labeling regulations and real-world applications for the development of product labels and the oversight of promotional material from the biopharmaceutical perspective.

Regulatory Affairs – ALP is an area in which skills cannot be obtained solely from a professional degree; instead, the necessary knowledge is gained predominantly through on-the-job training and hands-on experience.

Biogen recognizes this critical need for experienced Regulatory Affairs – ALP professionals and has partnered with the marketing department to offer a fellowship with opportunities to experience and learn the following:

• The FDA regulations that govern advertising, labeling, and promotion

• How to accurately and effectively apply regulations and provide guidance

• How promotional materials are developed through the commercial organization

The overall goal of the program is to prepare each fellow to be a successful Regulatory Affairs – ALP professional with a solid understanding of how FDA regulations are followed by the biopharmaceutical industry and enforced by the FDA. Upon completion of the fellowship, the experienced fellow will be well-prepared to enter into an advanced career in Regulatory Affairs – ALP.

Regulatory Affairs – Advertising, Labeling, and Promotion Fellowship

REGULATORY AFFAIRS – ALP

9 months 3 months

6 months 6 months

US MARKETING REGULATORY AFFAIRS – ALP

ELECTIVE

2-YEAR PROGRAM



• Global Commercial

• Safety and Benefit-Risk Management

• Regulatory Development

• Global Market Access

Worldwide Medical Fellowship

12 months

12 months

9 | Worldwide Medical Worldwide Medical | 10

“The Worldwide Medical fellowship at Biogen provides a unique opportunity to gain exposure to a broad range of roles within Medical Affairs and other key functions, while also allowing the fellow to specialize in the area best aligned with their interests and career goals.”

James Lewin, PharmD Senior Manager, Medical Publications

“The Worldwide Medical fellowship provides fellows with unique learning opportunities to foster professional development and establish a firm foundation for a career in the biopharmaceutical industry.”

Heather Abourjaily, PharmD Director, Medical Communications

Program Directors

“This collaborative endeavor brought together by MCPHS and Biogen creates an impressive array of resources and learning opportunities for the aspirational industry pharmacist. The stimulating and inspired network here provides impetus for self-discovery as well as longitudinal career growth towards the future.”

Jonathan Wang, PharmDUniversity of Pittsburgh

First-Year Fellow

“As an integral part of the Worldwide Medical program within the burgeoning Biogen enterprise, the fellow is immersed in its culture of ingenuity, passion, and excellence, all of which contribute to a fellow’s intellectual and professional growth.”

Kyle Terpak, PharmD The University of Michigan College of Pharmacy

Second-Year Fellow

About Worldwide Medical Biogen’s Worldwide Medical (WWM) department mission is to inform real-world medical practice and to optimize patient outcomes by generating, assimilating, and delivering clear, timely, clinically relevant information that addresses unmet medical needs. We do this by providing support to Research and Development, Corporate Development, and Global Commercial Operations, and by being responsible for clinical development and research, medical publications, biostatistics, medical education, and many other services. Worldwide Medical is also responsible for providing healthcare professionals, 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 functional areas within Worldwide Medical. If desired, the fellow will have the opportunity to select a rotation outside of Worldwide Medical for greater experience and understanding of the biopharmaceutical industry.

For the second year of the fellowship, the fellow will pick an area of concentration to prepare them for a career within the pharmaceutical industry. The area of concentration must be within Worldwide Medical.

The potential functional group rotations are:

• Medical Communications

• Medical Information and Congress

• Medical Training

• Medical Planning and Operations

• Medical Director’s Office

• Medical Publications

• Medical Research

• Insights and Analytics

• Medical Competitive Intelligence

FUNCTIONAL GROUP ROTATIONS

CORE FUNCTIONAL GROUP

2-YEAR PROGRAM

Medical and Value Based Outcomes Fellowship

1 month 1 month 3 months

4 months 3 months 12 months

MVBO

MVBO

MARKET ACCESS MEDICAL FUNCTION

PROJECT ELECTIVE

11 | Medical and Value Based Outcomes

About MVBOBiogen’s Medical and Value Based Outcomes (MVBO) team establishes and fosters ongoing professional relationships with key market access decision/policy makers. The team provides comprehensive medical education, collaborative research opportunities, and comparative effectiveness health outcomes solutions that seek to improve patient care within a cost-conscious and evolving healthcare environment.

During the first year of the fellowship, the fellow will obtain a working functional knowledge within the core groups with which MVBO partners. The fellow will also have an opportunity to choose a rotation outside of the core curriculum to enhance his or her experience and understanding of the biopharmaceutical industry.

The second year of the fellowship is dedicated to gaining an advanced experience within the MVBO team. The fellow will complete various research initiatives, present at congresses, partake in field medical market access interactions, and consistently work to be a trusted partner within the team.

Medical and Value Based Outcomes | 12

“Our MVBO fellowship offering provides a unique breadth of evidence generation strategy for payer stakeholders across all brand and pipeline products to transform patient lives. Future fellows will be well equipped for leadership in an evolving healthcare market.”

Eric Hall, II, PhD Associate Director, US Medical and Value Based Outcomes

Program Directors

“The Medical and Value Based Outcomes fellowship offers challenging and valuable experiences, impactful trainings, and mentorships necessary for professional excellence in the biopharmaceutical industry.”

Jon Kendter, PharmD Manager, US Medical and Value Based Outcomes

“The Medical and Value Based Outcomes fellowship program offers a premier 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 individual for success within the biopharmaceutical industry.”

Kun Yang, PharmD University of Maryland

First-Year Fellow



• Health and Economics Outcomes Research

• Value Based Medicine

• Pricing and Channel Distribution

• Patient Services

• US Medical Director’s Office

• Government Policy and Advocacy

• Global Market Access

• Worldwide Medical

2-YEAR PROGRAM

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12 –

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Worldwide Medical

Jon Kendter, PharmDUniversity of the Sciences,Philadelphia College of Pharmacy

Manas Prasad, PharmDUniversity of Connecticut, School of Pharmacy

Manager, Medical AffairsBiogen

In Progress

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20

142

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Regulatory Affairs – Advertising, Labeling, and Promotion

Richard Lem, PharmDRutgers University

Sheila Kundu, PharmDUniversity of the Sciences, Philadelphia College of Pharmacy

Manager, Regulatory AffairsBiogen

Senior Associate II, Regulatory AffairsBiogen

Fellowship Alumni (Cont’d)Fellowship Alumni (Cont’d)

13 | Fellowship Alumni

Fellowship Alumni

Hamdan Almas, PharmD University of California – San Francisco

Benjamin Exter, PharmD Northeastern University

Raymond Kim, PharmDUniversity of California – San Francisco

James Scanlon, PharmDNortheastern University

Amy Gangadharan, PharmDNortheastern University

Stephanie Fradette, PharmDNortheastern University

Desmond Murphy, PharmDNortheastern University

Kimberly Price, PharmDMassachusetts College of Pharmacy and Health Sciences – Worcester

Lauren Oliva, PharmDRutgers University, Ernest Mario School of Pharmacy

Associate Director, Oncology MarketingGILEAD Sciences, Inc.

Director, Global Pharmacovigilance Medical Safety Takeda Pharmaceuticals International Co.

Senior Manager, Medical InformationOnyx Pharmaceuticals

Senior Manager, Medical PublicationsBiogen

Safety Scientist, Safety Risk ManagementGenentech

Senior Manager, Regulatory AffairsBiogen

Senior Manager, New Product CommercializationBiogen

Manager, Medical InformationARIAD Pharmaceuticals

Manager, Regulatory AffairsBiogen

Regulatory Affairs – Safety and Benefit Risk Management

Alumnus/Alumna Current Position

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Frequently Asked Questions | 14

Frequently Asked QuestionsWhat is the timeline for the fellowship selection process?

• Participation in the ASHP Midyear Clinical Meeting Personnel Placement Service (PPS) is strongly encouraged, but not required.

• To request an interview, select the fellowship program(s) of interest through the PPS portal, and please provide your contact information and a copy of your CV.

• Applicants may submit their application materials before or after the ASHP Midyear Clinical Meeting. All application materials must be received by January 2; however, applications will be accepted and 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.

• The selection process will be complete in late January.

Do I need previous industry experience in order to be considered for the fellowship program?

• No, previous industry experience is not required, but beneficial.

Do I have to be a registered pharmacist to qualify for this fellowship?

• 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.

Will I be able to defer my student loans?

• Yes, provided that the student loan company accepts fellowship deferment. For more information regarding eligibility and terms of deferment, candidates should contact their lender(s).

Can I apply for more than 1 fellowship at Biogen?

• Yes, we welcome potential applicants to explore all of the opportunities available at Biogen.

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 for the formal application.

Are there any other elective options available that are not listed?

• All elective options are subject to availability. Additional options may be available depending on interest.

Regulatory Affairs Fellowship

Fellowship Overview

Biogen’s Regulatory Affairs fellowship will pri-marily focus on the Trial Master File (TMF) and Clinical Trial Application (CTA). Over the course of 2 years, the fellow will be a member of cross functional teams and work with key individuals that have a comprehensive knowledge of the Regulatory requirements for the planning, con-duct and reporting of clinical trials. Within both groups, the fellow will have the opportunity to complete various research initiatives.

Trial Master File (TMF)

The Trial Master File is our evidence that the integrity of the trial data, study analysis and study conclusions are credible, that patient rights and safety have been protected and lastly, the TMF is considered the autobiography of a study. During the first year of the fellow-ship, the fellow will obtain a functional working knowledge within the TMF group and with TMF partners such as Global Clinical Operations, Safety and Benefit Risk Management and Clini-cal Data Management. Maintenance of the accurate and appropriate documentation is needed for managing the conduct of clinical trials and enables evaluation by audit or in-spection for Good Clinical Practices (GCP) com-pliance. The team provides comprehensive Regulatory training and education as well as collaborative research opportunities with pro-fessionals in the clinical environment. This training will be the foundation for the second year of the fellowship.

New for the fellowship years of 2016-2018

WWM is now recruiting for two new fellows. See the brochure for more details.

A new fellowship program in Regulatory Affairs. See below for more details.

Clinical Trial Application (CTA)

The second year of the fellowship, the fellow will gain direct experience with the CTA team. The CTA management team is responsible for managing international clinical trial applica-tions to health authorities. In doing so, the team is accountable for the oversight of Clini-cal Research Organizations (CRO) and the col-laboration with Biogen to ensure execution of the submission of these applications. The CTA team is a member of a cross-functional study team where they provide regulatory strategy for the studies. The fellow will support the CTA lead with start-up and maintenance activities for various studies.

Application Procedure

Please see the Eligibility and Application Proce-dure sections in the Biogen Fellowship Brochure.

Please send the appropriate application materials to the email and mailing addresses below.

Dura on 2 Years

Posi on 1

Start Date July 1

Program Design

Application Information

Email RegSafetyFellowship

@biogen.com

Mailing

Address

Stacie Knight

Regulatory Affairs

Biogen

300 Binney Street

Cambridge, MA 02142

biopharmaceutical industry pharmd fellowships - biogen

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