2016 Pfizer Fellowship Program in partnership with Institute for Pharmaceutical Industry Fellowships Introduction to the Pfizer Fellowship Program TABLE OF CONTENTS Greetings from Freda Lewis-Hall . . . . . . . . 2 Overview of Pfizer, Inc. . . . . . . . . . . . . . . 3 Pfizer’s Global Commercial Organization Structure . . . . . . . . . . . . . . 4 Pfizer’s OWNIT! Culture . . . . . . . . . . . . . 5 Recruiting Positions for 2016 . . . . . . . . . . 7 Global Medical Information (GMI) and Global Medical Affairs (GMA) in Global Innovative Pharma (GIP) Pfizer Consumer Healthcare (continued) Overview of Global Medical Information and Global Medical Affairs . . . . . . . . . . 15 Global Medical Franchise (non-recruiting) Current Fellows and Preceptors . . . . . . . 26 GMI / GMA Fellowship Description . . . . . 16 GMI / GMA Fellowship: Year 1 . . . . . . . . 17 Global Medical Affairs Current Fellow and Preceptor . . . . . . . . . 25 Regulatory Affairs Fellowship Overview . . . 27 Overview of Pfizer Oncology . . . . . . . . . . . 9 GMI / GMA Current Preceptors . . . . . . . . 19 Rutgers Pharmaceutical Industry Fellowship Program Oncology Medical Affairs Oncology Fellowship Description . . . . . . . 10 Pfizer Consumer Healthcare (PCH) Professional Development Series . . . . . . . 30 Medical Affairs Current Fellows and Preceptor . . . . . . . . 11 Overview of Pfizer Consumer Healthcare . . . . . . . . . . 20 Key Features . . . . . . . . . . . . . . . . . . . 31 Development & Training . . . . . . . . . . . . 21 Application and Eligibility Requirements . . . . . . . . . . . . 32 Global Established Pharma Business (GEP) Clinical Research & Development Fellowship Overview . . . . . . . . . . . . . . 22 Alumni Spotlight . . . . . . . . . . . . . . . 33 Overview of Global Established Pharma . . . . . . . . . . 12 Clinical Research & Development Current Fellows, Preceptors and Stakeholders . . . . . . . . . . . . . . . . 23 Pfizer Oncology GEP Medical Affairs Fellowship Description . . . . . . . . . . . . . 13 GEP Medical Affairs Current Fellows and Preceptors . . . . . . . . 14 GMI / GMA Fellowship: Year 2 . . . . . . . . 18 Program History . . . . . . . . . . . . . . . . . 29 Clinical Medical Affairs Fellowship Overview . . . . . . . . . . . . . . 24 2016 PFIZER FELLOWSHIP PROGRAM 1 Introduction to the Pfizer Fellowship Program GREETINGS FROM FREDA LEWIS-HALL I would like to extend a warm welcome to our partners at Rutgers University and to those candidates who are considering the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program. One of Pfizer’s strengths is found in the many talented colleagues in Clinical Research, Medical Affairs, and Global Franchise Medical who support biomedical innovation and patient safety. As you will read in the coming pages, Pfizer has a partnership with Rutgers and greatly supports the RPIF program, through which Fellowship Alumni have gone on to a wide range of leadership opportunities within Pfizer— and our industry. We are proud that we are offering a Fellowship this year in Clinical Research within Consumer Healthcare, as well as positions in Medical Affairs in Oncology. Through this process, we invite you on a journey of personal and professional exploration. You will come to learn that Pfizer colleagues are among the best in our industry and totally dedicated to better health outcomes for more of the world’s people. I wish you great success throughout this process and in your future endeavors. Sincerely, reda Lewis-Hall, MD F Executive Vice President & Chief Medical Officer Pfizer Inc 2016 PFIZER FELLOWSHIP PROGRAM 2 Introduction to the Pfizer Fellowship Program OVERVIEW OF PFIZER, INC. Mission Statement To be the premier, innovative biopharmaceutical company Pfizer Collegeville, PA Working Together for a Healthier World Our diversified global health care portfolio includes human and small molecule medicines and vaccines, as well as many of the world’s best-known consumer products. unparalleled resources and world-class facilities as well as the opportunity to work on groundbreaking research. We are dedicated to hiring, retaining and inspiring our colleagues by offering some of the best growth opportunities available in the industry. Pfizer encourages and rewards a culture of idea sharing, critical thinking, and continuous improvement. Each position at Pfizer touches and contributes to the success of our business and our world. This is the reason Pfizer is committed to hiring highly qualified candidates for all areas of our business. We celebrate the differences that create the mosaic culture of Pfizer, especially the diversity of thought. We nurture these individuals with access to Pfizer is focusing unparalleled scientific and financial resources on discovery, development, and delivery of medicines that people need. As the ever changing pace of healthcare around the world continues to accelerate, we are evolving by adapting to our stakeholders’ needs. Consistent with our responsibility as the world’s leading biopharmaceutical company, we are collaborating with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Pfizer will succeed by being customer-focused, entrepreneurial, and agile. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Locations: Pfizer Consumer Healthcare HQ Madison, NJ Pfizer, NYHQ 235 East 42nd Street New York City, New York 10017 Pfizer Consumer Healthcare HQ 1 Giralda Farms Madison, NJ 07940 Pfizer, Collegeville 500 Arcola Rd. Collegeville, PA 19426 Pfizer NYHQ 2016 PFIZER FELLOWSHIP PROGRAM 3 Introduction to the Pfizer Fellowship Program PFIZER’S GLOBAL COMMERCIAL ORGANIZATION STRUCTURE Global Commercial Business Our operating structure represents the next steps in Pfizer’s journey to further revitalize our innovative core, enhance the value of our consumer and off-patent established brands and maximize the use of our capital to deliver value to patients and our shareholders. Through this evolution, we are enabling greater independence, focus and responsiveness for our commercial business. Vaccines, Oncology & Consumer Healthcare Global Innovative Pharma Inflammation/ Immunology Global Established Pharma Vaccines LOE Products Oncology Biosimilars Consumer Healthcare EP/EM Collaborations CV/Metabolic Neuroscience Pain {{ Mylan in Japan Rare Diseases {{ Hisun in China Men’s/Women’s Health {{ Teuto in Brazil Generally includes products that are expected to have exclusivity beyond 2015 Includes businesses with different operating models and distinct specializations Global Established Pharma Business Includes LOE products and generally the patentprotected products that are expected to lose exclusivity through 2015 2016 PFIZER FELLOWSHIP PROGRAM Global Innovative Pharma Business Worldwide Research & Development Pfizer Global Supply Vaccines, Oncology and Consumer Business Enabling Functions 4 Introduction to the Pfizer Fellowship Program PFIZER’S OWNIT! CULTURE: A CULTURE EMBEDDED IN THE BUSINESS Pfizer understands that for prospective colleagues, a company’s internal culture is as important as its external reputation. With its emphasis on “ownership”, Pfizer’s OWNIT! culture allows individual colleagues to discover career success at the same time that it drives positive business results. OWNIT! encourages all colleagues to take ownership for their careers and make a positive impact on the business. This means that innovation and new ideas are met with openness and careful consideration, not skepticism and dismissal. It means everyone, no matter what their role, strives for excellence. Pfizer colleagues take accountability for their work and deliver on their commitments with speed, decisiveness and integrity. Pfizer’s OWNIT! culture is about all of our colleagues striving to impact results… this month, this quarter, this year and for many years in the future. customer customer focusfocus community community respect respect for people for people customer customer customer focusfocus focuscommunity community communityrespect respect for respect people for people for people customer customer customer focusfocus focuscommunity community community respect respect for respect people for people for people customer focus customer focus community community respect for people performance collaboration performance performance collaboration collaboration performance performance performance collaboration collaboration collaboration performance collaboration leadership leadership integrity integrity integrity integrity quality performance performance performance respect for people quality quality quality leadership leadership leadership integrity integrity integrity integrity quality collaboration leadership leadership leadership leadership leadership integrity integrity quality quality quality collaboration collaboration quality quality innovation innovation innovation innovation innovation innovation O W N I T own… the business win… in the marketplace no jerks… let’s discuss behaviors impact… results trust… in one another innovation innovation innovation innovation 2016 PFIZER FELLOWSHIP PROGRAM 5 Introduction to the Pfizer Fellowship Program Pfizer PFIZER’S OWNIT! CULTURE: A CULTURE EMBEDDED IN THE BUSINESS 2016 PFIZER FELLOWSHIP PROGRAM OWNIT! 6 Introduction to the Pfizer Fellowship Program RECRUITING POSITIONS FOR 2016 NEW YORK CITY, NY MADISON, NJ Medical Affairs Oncology 1 Year Clinical Research & Development Pfizer Consumer Healthcare 2 Years Medical Affairs Global Established Pharma 1 Year Global Medical Affairs Pfizer Consumer Healthcare 2 Years Global Medical Information/Global Medical Affairs 2 Years 2016 PFIZER FELLOWSHIP PROGRAM Regulatory Affairs Pfizer Consumer Healthcare 2 Years 7 Introduction to the Pfizer Fellowship Program 2016 PFIZER FELLOWSHIP PROGRAM 8 Introduction to the Pfizer Oncology Pfizer Fellowship Program OVERVIEW OF PFIZER ONCOLOGY At Pfizer Oncology, our focus is on working together with our partners in the oncology community to find ways to cure or control cancer Our scientists and researchers working in state-of-the-art labs are focused on the discovery and development of novel compounds As science in oncology continues to evolve, Pfizer is pursuing research centered around a personalized approach to cancer treatment and tailoring therapy based on the molecular and/or biologic make-up of the disease. Currently, our portfolio includes six products approved by the FDA for use in the United States. We also have a robust pipeline consisting of a number of biologics and small molecules in various stages of clinical development. Supporting this development are teams of dedicated people focused on understanding the specific needs of patients with cancer and providing support to oncology investigators and practitioners on the front line. Among these highly matrixed teams is Medical Affairs, which plays an integral role in drug development. Ivan P. Levinson, MD North American Lead for Oncology Medical Affairs 2016 PFIZER FELLOWSHIP PROGRAM From Pfizer’s global headquarters in New York City, Medical Affairs enables physicians to help patients by providing data about our approved products as well as those investigational products in our research pipeline. We manage internal and external medical communications, provide medical leadership in the development of new and improved treatment paradigms, and generate and handle powerful health outcomes-based data. We also partner with our cross-functional colleagues to ensure clinical trial and reimbursement strategies are optimized for the successful launch of our newest products. As the healthcare industry becomes more data-driven, Medical Affairs has expanded to three vital areas: Generating critical post-launch safety and efficacy data to demonstrate the effectiveness and value of our medicines Collaborating with investigators to improve cancer treatment by providing medications for experimental studies Helping physicians to improve the current standard of care The next critical step is communicating medical information broadly to reach the oncologists, healthcare providers, and patients who really need it. We respond to questions in the field, provide expert assistance at most medical congresses, and publish the kind of groundbreaking research that showcases Pfizer’s leadership in cancer research. 9 Introduction to the Pfizer Oncology Pfizer Fellowship Program ONCOLOGY MEDICAL AFFAIRS FELLOWSHIP OVERVIEW The purpose of this one-year fellowship program is to provide PharmDs with the skills and experience to launch a successful career in the pharmaceutical industry through specialized training in Oncology Medical Affairs. The Pfizer Oncology Medical Affairs Fellowship offers a broad overview of important areas within the pharmaceutical industry, from clinical trial design and site selection to how we respond to the needs of practicing oncologists. This broad exposure will also provide valuable networking opportunities for PharmDs. Fellows will expand their clinical knowledge through active participation on the Oncology US Medical Affairs team. Fellows will also be expected to work closely with Medical Directors and provide support in the development and execution of a broad range of medical affairs activities. 2016 PFIZER FELLOWSHIP PROGRAM The fellowship program emphasizes three main areas of development: DEVELOP CRITICAL INTERACTION SKILLS AND BUILD A NETWORK Collaborate across cross-functional teams including marketing, regulatory affairs, public affairs, communications, outcomes research, and clinical research Attend scientific and medical conferences and report on key findings Interact with key medical opinion leaders and other health care practitioners Support key collaboration with Outcomes Research team to develop strategy, implement studies, and interpret data TRANSFER KNOWLEDGE AND BECOME A VALUED TEAM MEMBER Provide insight to team members regarding current practices and potential future paradigm shifts Provide input into the development of medical publications, ensuring that manuscripts are scientifically accurate Provide medical review of promotional materials Participate in medical slide development and review, including training documents for fieldbased colleagues GAIN EXPERIENCE IN THE OPERATIONAL ASPECTS OF INDUSTRY Assist in coordination and planning of advisory board meetings Review of investigatorled research proposals Research, create, and review medical response letters and dossiers in order to develop fair and scientifically balanced responses to medical inquiries Partner with fieldbased Medical colleagues in supporting investigator-led studies, communicating with health care professionals, and supporting research activities There will also be opportunities to gain experience through rotations in health economics and outcomes research, medical information, and medical communication. 10 Introduction to the Pfizer Oncology Pfizer Fellowship Program ONCOLOGY MEDICAL AFFAIRS: CURRENT FELLOWS AND PRECEPTOR PAST FELLOW TESTIMONIAL “The Rutgers Fellowship program provides a platform for fellows to develop as future professionals within their respective companies while collaborating with colleagues and faculty at Rutgers University.” Bryan Murray, PharmD, MBA Manager, Medical Information Pfizer Medical Rutgers Fellowship 2014-2015” Left to Right FELLOWS Kristin Jarrell, PharmD Medical Affairs in Oncology Audrey Schnell, PharmD Medical Affairs in Oncology PRECEPTOR Marc Chioda, PharmD Medical Director, Oncology 2016 PFIZER FELLOWSHIP PROGRAM 11 Introduction to the Global Established Pharma (GEP) Pfizer Fellowship Program OVERVIEW OF GLOBAL ESTABLISHED PHARMA (GEP) Global Established Pharma (GEP) is a dynamic and highly-diverse business with unique opportunities for growth across a portfolio of several hundred products. We represent more than half of Pfizer’s total revenues, and are comprised of four different portfolio segments: Medicines that will shortly go off patent in developed markets (also known as Peri-Loss of Exclusivity (LoE) Growth opportunities such as biosimilars, sterile injectables, and surgicals, as well as partnerships in key markets and targeted opportunities in the developed markets Our work spans across the following therapeutic areas: Older established medicines that are off-patent in developed markets CV/Metabolic CNS Pain/Inflammatory Older established medicines in emerging markets Women’s Health Anti-Infectives 2016 PFIZER FELLOWSHIP PROGRAM Our strategic intent is to make a meaningful contribution to improving global health through: The quality and “fit” of our portfolio to the needs of our customers Innovative customer engagement and service The diversity, talent, entrepreneurial spirit and integrity of our colleagues We have a truly global footprint, with significant areas of growth both in emerging and developed markets. GEP Global & Clinical Medical Affairs Vision To maintain and improve the health of more and more people of all ages worldwide 12 Introduction to the Global Established Pharma (GEP) Pfizer Fellowship Program MEDICAL AFFAIRS FELLOWSHIP OVERVIEW Fellows will develop in the following key areas: The purpose of this one year fellowship is to provide PharmDs with not only a comprehensive foundation in Medical Affairs, but also the skill set to launch a successful career in the pharmaceutical industry. PROMOTIONAL OVERSIGHT This one-year fellowship is designed to facilitate understanding of both the strategic and operational aspects of Medical Affairs within the Global Established Pharma Business Unit. The fellowship will afford PharmDs with the unique experience and professional growth associated with the challenges posed in a global pharmaceutical environment. In addition to developing strategy and providing support during the post-LOE and peri-LOE phases, the fellow will also be able to develop their expertise across multiple disease states including CV/Metabolic, CNS, Pain/Inflammatory, Women’s Health, and Anti-Infective therapies. Fellows will work in broad range of medical affairs activities and play an integral role by participating on review committees and educational field medical activities, as well as working with opinion leaders and key stakeholders on advisory boards. Provide medical guidance on commercial projects including strategy, material review, and training Verify medical content in promotional materials for correctness and medical accuracy Collaborate across cross-functional teams including marketing, regulatory affairs, public affairs, communications, global health and value, and clinical research Participate in medical slide development and review, including training documents for field-based colleagues Provide input into the development of medical publications, ensuring that manuscripts are scientifically accurate PROFESSIONAL INTERACTIONS Support key collaboration with Global Health and Value teams to develop strategy, implement studies, and interpret data Assist in coordination and planning of advisory board meetings Review of investigatorled research proposals Research, create, and review medical response letters and dossiers in order to develop fair and scientifically balanced responses to medical inquiries MEDICAL OVERSIGHT 2016 PFIZER FELLOWSHIP PROGRAM Provide insight to team members regarding current practices and potential future paradigm shifts Attend scientific and medical conferences and report on key findings Interact with key medical opinion leaders and other health care practitioners Partner with field-based Medical colleagues in supporting investigator-led studies, communicating with health care professionals, and supporting research activities PROFESSIONAL DEVELOPMENT Create new programs, trainings, and educational material for patients and providers Establish and carry out a budget for assigned products Participate in various Pfizer-led leadership training seminars During the fellowship, Fellows will also have the opportunity to rotate throughout various Clinical and Medical Affairs teams based on their interests, including, but not limited to Clinical Development, Business Development and Clinical Pharmacology. 13 Introduction to the Global Established Pharma (GEP) Pfizer Fellowship Program MEDICAL AFFAIRS FELLOWSHIP: CURRENT FELLOWS AND PRECEPTORS Top Row (left to right) FELLOWS Pardis Tabrizi, PharmD Medical Affairs in Global Established Pharma Fellow Praneeta Nagraj, PharmD Medical Affairs in Global Established Pharma Fellow Middle Row (left to right) PRECEPTOR Damian Largier, MD GEP Global Medical Affairs Lead Pol Vandenbroucke, MD, MBA GEP Regional Medical Lead North America Eddie G.M. Power, PhD, MBA GEP Lead/Senior Director US Medical Affairs Bottom Row (left to right) Rahul Bhambri, PharmD GEP US Medical Director Gustavo Enrique Rodriguez, PharmD GEP US Associate Medical Director 2016 PFIZER FELLOWSHIP PROGRAM 14 Global Medical Introduction Information to the/ Global Medical Pfizer Fellowship Affairs (GMI/GMA) Program OVERVIEW OF GLOBAL MEDICAL INFORMATION AND GLOBAL MEDICAL AFFAIRS IN GLOBAL INNOVATIVE PHARMA About Global Medical Information GMI aims to strengthen Pfizer’s mission and purpose by ensuring access to information and knowledge that significantly impacts patient care. The mission of GMI is to optimize health outcomes by providing trusted clinical and scientific product information to HCPs and patients. Our product expertise and customer interactions enable us to share valuable insights with our internal partners and to develop innovative solutions that support the MI needs of our customers. Medical Information has a global footprint and is part of Pfizer’s External Medical Communications (EMC) division. EMC and GMI work to ensure that Pfizer speaks with a single, strong, medical voice everywhere we serve patients in order to maximize the medical impact of our products. GMI achieves this through state-of-the-art medical information services. 2016 PFIZER FELLOWSHIP PROGRAM About Global Medical Affairs-Global Innovative Pharma Global Innovative Pharma (GIP) is focused on developing, registering and commercializing novel, value-creating medicines that significantly improve patient’s lives. The purpose of GIP-Global Medical Affairs is to create, demonstrate, and communicate the clinical value of our medicines whilst maintaining the primacy of patient’s best interests. Our mission is to enhance the knowledge of our medicines and the associated therapeutic areas in which we focus our research efforts and interpret emerging scientific trends, clinical data and the competitive landscape and align internal stakeholders on a balanced benefit-risk proposition. The GIP-Global Medical Affairs group communicates with the medical and scientific communities in an accurate, fair and balanced manner about the benefits and the risks of our medicines enabling prescribers and other healthcare decision makers to make informed decision with patients and use our medicines safely and effectively. We champion patients’ interests by ensuring that improving patients’ lives remains the primary focus of everything we do at Pfizer. 15 Global Medical Introduction Information to the/ Global Medical Pfizer Fellowship Affairs (GMI/GMA) Program GMI / GMA FELLOWSHIP OVERVIEW 1 Two-Year Fellowship in GMI/GMA Building a Strong Foundation Development and Networking Opportunities The GMI/GMA Fellowship is a unique two-year program that is designed to provide customized and practical learning opportunities that will provide a comprehensive foundation and advanced experience that will enable the Fellow to prepare for a strong career in the pharmaceutical industry. The first year will be focused in Global Medical Information and the second year will be focused in Global Medical Affairs within Global Innovative Pharma. The Global Medical Information and Global Medical Affairs—Global Innovative Pharma Fellowship will afford the Fellow opportunities to develop and exhibit medical professionalism and build a network of industry colleagues. 2016 PFIZER FELLOWSHIP PROGRAM The Fellow will participate in relevant corporate training programs that are focused on building medical professionalism and leadership. The Fellow will interact with and build a network of Pfizer colleagues in crossfunctional global and regional areas that may include (but not be limited to): Medical Affairs Commercial Market Research Legal Public Affairs Field-Based Medical Regulatory Affairs Outcomes and Evidence Independent Grants for Learning and Change Innovative Research Collaborations 16 Global Medical Introduction Information to the/ Global Medical Pfizer Fellowship Affairs (GMI/GMA) Program GMI / GMA FELLOWSHIP OVERVIEW The GMI year of the Fellowship program is focused on development of expertise in the following areas: Global Medical Information Year 1 (2016-2017) UNDERSTAND the medicine, therapeutic area, and the information needs of the medical community, patients, and caregivers: 2016 PFIZER FELLOWSHIP PROGRAM Develops and leverages expertise as a subject matter expert for assigned Pfizer product(s) and associated therapeutic area(s) Proactively analyzes inquiry data to identify customer insights, trends and subsequently constructs and executes strategic action plans as appropriate when key medical and customer issues are identified GENERATE valued clinical and scientific responses to assist in making informed healthcare decisions Performs in-depth research, analysis, and interpretation of the medical literature from both external and internal sources Researches assigned escalated medical information inquiries including utilization of medical resources, clinical knowledge, and the scientific literature Actively participates in/ leads the creation and maintenance of regional and global MI scientific response documents by ensuring that responses are medically and scientifically accurate, timely, fair balanced, and meet customers’ needs COMMUNICATE to customers and stakeholders to facilitate the safe and effective use of Pfizer Prescription products: Provides balanced, scientific, and evidence-based answers to unsolicited medical questions from our customers Actively participates and interacts with medical colleagues (Medical Affairs and Field-Based Medical) and crossfunctional team members (Regulatory Affairs, Corporate Counsel, Media Relations, Commercial) and contributes to the management of product issues/crises/business objectives Participates in strategic initiatives designed to enhance the delivery of medical information through digital channels 17 Global Medical Introduction Information to the/ Global Medical Pfizer Fellowship Affairs (GMI/GMA) Program GMI / GMA FELLOWSHIP OVERVIEW The GMA-GIP year of the Fellowship program is focused on developing a broad exposure to the following within the Cardiovascular / Metabolic therapeutic area: Global Medical Affairs Year 2 (2017-2018) UNDERSTAND the medicine, therapeutic area and customer perspectives: 2016 PFIZER FELLOWSHIP PROGRAM Understand and interpret clinical data, emerging scientific trends and the competitive landscape and align internal stakeholders on a balanced benefit-risk proposition Partner with key thought leaders, professional societies, patient and disease advocacy groups to better understand and gain insights into areas of unmet medical need for patients and help shape life-cycle management strategies GENERATE inform the creation, acquisition, evaluation & integration of clinical data and content: Participate in publication subcommittee meetings to plan and implement appropriate publication strategies and tactics for the medicine Proactively collaborate in the development and review of promotional materials Assist in the development of medical content for congresses, symposia, speaker training and advisory boards Assist in the development of a life-cycle management strategy that improves the clinical care of patients by addressing unmet medical needs through various channels (ex. phase IV trials, investigator-initiated research (IIRs), real world data, etc.) COMMUNICATE in an accurate, fair and balanced manner the benefit-risk, appropriate use & clinical value of our medicines: Serve as a reliable, trusted resource for accurate, current medical and scientific knowledge (e.g.: disease states, product label), including competitive medicines, for internal and external stakeholders and customers Develop communication tools that provide an accurate, fair and balanced perspective of our medicines enabling prescribers and other healthcare decision makers to make informed decisions with patients and use our medicines safely and effectively 18 Global Medical Introduction Information to the/ Global Medical Pfizer Fellowship Affairs (GMI/GMA) Program GMI / GMA FELLOWSHIP: CURRENT PRECEPTORS Global Medical Information (First Row, left to right) Allison Soloff, PharmD Director, Medical Information AnnaMaria D’Ascoli, PharmD, MBA Senior Manager, Medical Information Global Medical Affairs (Second Row, left to right) Younos Abdulsattar, PharmD, BCPS Medical Director, Global Medical Affairs, GIP Dave DeMicco, PharmD CV/Metabolic Medical Affairs Lead, Global Medical Affairs, GIP Lisa Tarasenko, PharmD, MBA Senior Medical Director, Global Medical Affairs, GIP 2016 PFIZER FELLOWSHIP PROGRAM 19 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program OVERVIEW OF PFIZER CONSUMER HEALTHCARE Pfizer Consumer Healthcare products support millions of people daily in more than 90 countries by enhancing their well-being. Whether it is promoting wellness, relieving symptoms or alleviating pain, our products are among the world’s leading non-prescription brands, including – Advil, Caltrate and Centrum – that are the #1 products in the world in their respective categories. As an integral business unit of Pfizer Inc., PCH’s success is grounded in superior science, built on expert leadership and accelerated by innovation at each step of the research, development, regulatory and marketing process. Today, consumers are becoming more empowered to manage their personal well-being, consequently, PCH’s iconic brands are leading the way in providing accessible, affordable and trusted OTC self care products to consumers worldwide. Clinical Research & Development, Medical Affairs, and Regulatory Pfizer Consumer Healthcare, in partnership with the Ernest Mario School of Pharmacy at Rutgers University, is offering two year pharmaceutical industry fellowships in clinical research and development, medical affairs, and regulatory. The first year will focus on obtaining a well- 2016 PFIZER FELLOWSHIP PROGRAM rounded foundation in the fellow’s respective area, and the second year will provide the opportunity to rotate to different departments based on interest. The fellows will experience indepth, hands-on training and work among crossfunctional teams – learning and developing relationships with regulatory, product development, marketing, project management and legal colleagues. There will also be opportunities to attend conferences and seminars for continued education and networking with industry professionals. PCH’s fellowship program is designed to develop the communication, management and technical skills that are the solid foundation for a successful career in the pharmaceutical field. Pfizer Consumer Healthcare Mission At PCH we have a passion to improve the lives of people around the world, by empowering them to take health and wellness into their own hands through the innovation and expertise of Pfizer. 20 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program DEVELOPMENT & TRAINING Conducting a clinical trial or communicating with healthcare providers are integral processes that involve multiple departments across the organization. Stakeholders Not Pictured To assist fellows in understanding this process, we connect them with advisors who are leading the cross-functional collaborations. Fellows will have the opportunity to work closely with the advisors and immerse themselves into the work and teams of the different departments. The advisors will serve as educators, mentors and guides to fellows as they receive hands-on training and develop professionally. Left to Right Juby Jacob-Nara, MD, MPH, MBA Chief Medical Officer & Vice President of Global Clinical Development & Medical Affairs Josephine Fubara, PhD Vice President, Global R&D Franchise Lead, GI Peter John Ramsey, PhD Senior Vice President, Senior VP of Global Health Michael Bailey Head of Regulatory Affairs, North America & Rx-to-OTC Switch Program Director for Pfizer Pharmaceutical Industry Fellowship Program 2016 PFIZER FELLOWSHIP PROGRAM 21 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program CLINICAL RESEARCH & DEVELOPMENT FELLOWSHIP OVERVIEW Fellows who pursue a position in PCH’s Global Clinical Research and Development Department as their core rotation will develop the following expertise: Execute clinical trial programs according to established quality standards (Good Clinical Practices (GCP), external guidelines / regulations, and internal processes) and agreed upon budget and time lines {{ Develop innovative study models to align with commercial and regulatory goals for product launch {{ Communicate study {{ Generate and store relevant documents for study in collaboration with regulatory, clinical development, and franchise functional groups {{ Present protocols at Investigators’ meetings and Study Initiation meetings {{ Serve as the study clinician on clinical studies and work with Clinical Operations requirements and updates to team for efficient progress of clinical development programs in the fastpaced market of consumer healthcare 2016 PFIZER FELLOWSHIP PROGRAM Provide clinical strategy, i.e., required clinical studies, to obtain product approval in multiple countries {{ Write clinical study reports and clinical efficacy and safety sections of regulatory documents {{ Prepare for and attend meetings with FDA and other regulatory authorities Support success of Pfizer Consumer Healthcare {{ Partner with Rx-to- OTC Switch teams to develop new, first in class self-care therapies {{ Assist senior personnel in the preparation of reports for oral/written delivery at internal and external meetings This fellowship is designed to facilitate understanding both on strategic and operational aspects of clinical research. The fellow will be involved in the development of OTC products, medical devices and Rx-to-OTC switches in various therapeutic areas including pain management, respiratory, GI and personal care. During the second year of the fellowship, individuals will have the option to complete a rotation with the Therapeutics Franchise Teams, the Rx to OTC Switch Team, or may delve into other areas such as Regulatory Affairs, Project Management or Marketing. 22 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program CLINICAL RESEARCH & DEVELOPMENT FELLOWSHIP: CURRENT FELLOWS, PRECEPTORS, AND STAKEHOLDERS Top Row (left to right) FELLOWS Edmund Arthur, PharmD Clinical Research & Development Fellow Vani Kumaran, PharmD Clinical Research & Development Fellow Middle Row (left to right) PRECEPTORS Mario Cruz-Rivera, PhD, MPH, FCAAAI, FAAAAI Senior Director, Global Clinical Research & Rx-to-OTC Switch David Savastano, PhD Director, Clinical Research Bottom Row (left to right) STAKEHOLDERS James T. Angello, PharmD Senior Director, Global Clinical Research Anne LeMoigne Senior Director, Clinical Excellence & Biometrics Lisa A. Baird, MS Senior Director, Clinical Operations 2016 PFIZER FELLOWSHIP PROGRAM 23 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program GLOBAL MEDICAL AFFAIRS FELLOWSHIP OVERVIEW Fellows who pursue a position in PCH’s Global Medical Affairs department as their core rotation will: Have involvement with key healthcare providers in exchange of scientific and medical ideas including Advisory Boards and presentations at national meetings Provide medical guidance on commercial projects including strategy, material review and training Facilitate communications between PCH Medical and the Study Investigators, and oversee the publication of clinical trial results both at scientific meetings and in peer reviewed journals Initiate and build collaborations with other business units within Pfizer on projects of mutual scientific interest and integrate joint medical activities and initiatives Collaborate with Worldwide Safety Strategy in setting the overall safety strategies and providing benefit-risk assessments for PCH’s portfolio of products 2016 PFIZER FELLOWSHIP PROGRAM Collaborate with the commercial unit and provide scientific input for the development and review of promotional materials, documents and presentations developed for the assigned drugs and/or indications Develop relevant parts of the medical affairs tactical plans, and/ or complete other special projects such as preparation and review of training materials for field forces Coordinate and liaise with internal and external providers for data mining activities Provide data outputs requested for safety and/ or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications Coordinate the preparation of, and review data outputs for, reporting documents where appropriate (e.g. clinical study reports, analysis plans, etc.) with the Contract Research Organization, the Biostatisticians and Clinical Research colleagues This fellowship is designed to facilitate understanding of both the strategic and operational aspects of global medical affairs across various therapeutic areas, including pain management, dietary supplements, respiratory, GI and personal care. During the second year of the fellowship, individuals will have the option to work more closely with the Therapeutics Franchise teams, the Rx-to-OTC Switch team, or depending upon interest, Regulatory Affairs, Project Management or Marketing. 24 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program GLOBAL MEDICAL AFFAIRS: CURRENT FELLOW AND PRECEPTOR FELLOW Unicel-Anne Flores, PharmD Global Medical Affairs Fellow PRECEPTOR Bill Bailey, PharmD Head of North America, Medical Affairs 2016 PFIZER FELLOWSHIP PROGRAM 25 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program GLOBAL MEDICAL FRANCHISE: CURRENT FELLOWS AND PRECEPTORS Top Row (left to right) FELLOWS Alexander Schepart, PharmD, MBA Pain Global Medical Franchise Fellow Agnes Hong, PharmD GI Global Medical Franchise Fellow Bottom Row (left to right) PRECEPTORS David Kellstein, PhD Senior Director, R&D Pain Management Charles Pollack, MD, PhD Senior Director, GI Medical Franchise GLOBAL MEDICAL FRANCHISE IS NOT RECRUITING FOR 2016 2016 PFIZER FELLOWSHIP PROGRAM 26 Introduction to the Pfizer Consumer Healthcare Pfizer Fellowship Program REGULATORY AFFAIRS OVERVIEW Whether you have entertained the idea of academic research or have career aspirations for business within the pharmaceutical industry, the scientific discipline of Regulatory Affairs provides you a unique line of sight to drug development process, giving rise to the opportunity to touch on every aspect of research and development as well as engage with key business disciplines throughout the lifecycle of a given health or wellness product. If you would you like to experience work in a multicultural and diverse environment of a global healthcare company, then this program is for you as it will allow you to discover the multiple touch points of Regulatory Affairs. Upon selection, you will be offered a place in our 2-year Regulatory Program, consisting of rotation assignments within Pfizer Consumer Healthcare and broader Pfizer business units. Some aspects of this program include the following: Participate in the Review and Approval of Labeling and Advertising & Promotion across one or more Therapeutic Areas Contribute in the Development of Regulatory Strategies for project/product registrations and launches Assist in the implementation of training/orientation programs for onboarding within and outside of regulatory strategy Conduct due diligence on competitive landscape of consumer products and on-package claims, identifying consistent and inconsistent approaches to consumer messaging of molecule class within industry Help facilitate education of key stakeholders and cross-functional team leaders with respect to regulatory science/ basics for local market requirements Gain experience in one or more Regulatory product classifications: NDA, Monograph, Medical Device, Cosmetic, Dietary Supplements Assist in the FDA product registration submission process Assist in solving various in-market regulatory issues and concerns Gain insights into the Rx-to-OTC Switch process as well as the Global, Regional and Country aspects of Regulatory Affairs 2 year program; 1st year within Pfizer Consumer Healthcare (PCH) Regulatory Affairs, 2nd year rotation options in various functions within PCH/Pfizer Inc. PRECEPTOR Christine Chirdo Director, US Regulatory Strategy Category Lead, GI/Respiratory/Personal Care Worldwide Regulatory 2016 PFIZER FELLOWSHIP PROGRAM 27 Rutgers Pharmaceutical Industry Fellowship Program Ernesto Mario School of Pharmacy Rutgers, The State University Introduction to the of New Jersey Pfizer Fellowship Program Ernesto Mario School of Pharmacy Rutgers Pharmaceutical Industry Fellowship Program History In 1984, at Rutgers, The State University of New Jersey, the Ernest Mario School of Pharmacy and two pharmaceutical companies began a collaborative pilot program to evaluate the potential contributions of clinically-trained pharmacists within a pharmaceutical industry practice setting. Following the successful pilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program grew significantly and expanded to include 17 companies within the pharmaceutical and biopharmaceutical industries and over 100 fellows annually. Dr. Michael Toscani Research Professor, Fellowship Director Institute for Pharmaceutical Industry Fellowship 2016 PFIZER FELLOWSHIP PROGRAM In 2002, Dr. Ernest Mario generously provided an endowment to establish the Institute for Pharmaceutical Industry Fellowships to enhance and promote the role of pharmacists in industry through the RPIF Program. The Institute staff members: provide leadership and administrative support; promote quality, communication, and scholarly activity; and arrange specialized fellowship training opportunities within the pharmaceutical and biopharmaceutical industries The RPIF Program has thrived under the leadership of the founder, Dr. Joseph A. Barone, Dean and Distinguished Dr. Joseph A. Barone Dean and Distinguished Professor II Ernest Mario School of Pharmacy Professor II of the Ernest Mario School of Pharmacy and Dr. Michael Toscani, Research Professor and the Fellowship Director for the Institute for Pharmaceutical Industry Fellowships. More than 800 postdoctoral fellows have completed the RPIF Program, most of whom are pursuing influential and rewarding careers in the pharmaceutical and biopharmaceutical industries throughout the US and abroad. The RPIF Program has preceptors/mentors from industry who share their knowledge and experiences with the fellows through an intense but closelyguided training program. Assignments and projects are challenging, meaningful, and designed to enhance understanding of the pharmaceutica and biopharmaceutical industries and the fellow’s functional area. 29 Rutgers, The State University Introduction to the of New Jersey Pfizer Fellowship Program Ernesto Mario School of Pharmacy Professional Development Series All fellows gather at Rutgers once or twice monthly as a group to participate in the Professional Development Day (PDD) Series, an important component of their training that complements the hands-on experience provided at the partner companies. The PDDs are steered by a committee of fellows and are designed to enhance the fellows’ presentation skills, promote connectivity and a sense of community among fellows from different companies and disciplines, develop new skill sets under the guidance of external trainers, and provide general knowledge about various aspects of drug development and issues facing the pharmaceutical and biopharmaceutical industries. The fellows learn from each other through individual and group presentations and debates on topics and issues related to the pharmaceutical and biopharmaceutical industries. This dynamic forum provides an opportunity for open discussion and debate among fellows, Rutgers faculty, and company preceptors. In addition, outside experts provide training and professional development in a variety of areas (e.g., tools for 2016 PFIZER FELLOWSHIP PROGRAM corporate success; professional writing, presentations, meeting facilitation, negotiating, influencing, networking, and conflict resolution skills; giving and receiving feedback; and business and dining etiquette). Other PDD guest speakers include industry executives, patient advocacy groups, and successful RPIF Program alumni who share their insights and experiences. Importantly, PDDs provide an excellent opportunity for fellows to interact with each other and develop lasting personal friendships and a strong professional network of fellows, faculty, alumni, and other industry executives 30 Rutgers, The State University Introduction to the of New Jersey Pfizer Fellowship Program Ernesto Mario School of Pharmacy Key Features F O The Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development of future pharmaceutical and biopharmaceutical industry professionals through the following key program features: 2016 PFIZER FELLOWSHIP PROGRAM amily of Leading Companies–Partners include several of the top 17 global pharmaceutical and biopharmaceutical companies. utstanding Alumni Track Record–Over 800 alumni hold prominent positions at many leading companies. S trong Network—Over 100 fellows each year develop valuable, lasting connections with each other, alumni, preceptors. T he Pathway to Industry–Since 1984, the Rutgers program has been nationally recognized, trusted, and proven as the pathway to industry for pharmacists. E nhanced Career Path–Increasingly challenging assignments build depth of experience and enhance the potential for an accelerated career path. R igorous Academic Component–Rutgers affiliation provides academic and professional development opportunities. 31 Rutgers, The State University Introduction to the of New Jersey Pfizer Fellowship Program Ernesto Mario School of Pharmacy Application Process and Eligibility Requirements Fellows for the Rutgers Pharmaceutical Industry Fellowship Program are selected on a nationallycompetitive basis. Candidates must have completed a Doctor of Pharmacy degree from an ACPE accredited institution before July 1 of the fellowship term. Participation in the ASHP Midyear Clinical Meeting/PPS is strongly encouraged. Interested individuals are invited to electronically submit a letter of intent, curriculum vitae, and three letters of recommendation to: ifellows@pharmacy.rutgers.edu Please address all correspondence to: Joseph A. Barone, PharmD., F.C.C.P. Dean and Distinguished Professor II Ernest Mario School of Pharmacy Rutgers, The State University of New Jersey 160 Frelinghuysen Road Piscataway, NJ 08854-8020 ifellows@pharmacy.rutgers.edu Application materials may be submitted as early as November 17, and applicants are encouraged to submit as many of the required materials as possible by December 15. All applicants should also electronically complete a Program Interest Form at: http://pharmafellows.rutgers.edu Rutgers University Piscataway, NJ 2016 PFIZER FELLOWSHIP PROGRAM 32 Introduction to the Alumni Spotlight Pfizer Fellowship Program GUSTAVO ENRIQUE RODRIGUEZ, PHARMD GEP US Associate Medical Director Rutgers Fellowship Class of 2014 “The Rutgers fellowship provided a great foundation for my career in the pharmaceutical industry. The experiences and opportunities through my fellowship have proven to be very valuable towards my professional development.” SAJID AHMED, PHARMD Manager, Aggregate Reports Analyst Rutgers Fellowship Class of 2015 “The Rutgers Fellowship program provides a platform for fellows to develop as future professionals within their respective companies while collaborating with colleagues and faculty at Rutgers University.” 2016 PFIZER FELLOWSHIP PROGRAM 33 Introduction to the Pfizer Fellowship Program www.pfizer.com 2016 PFIZER FELLOWSHIP PROGRAM 35