MCPHS University and Pfizer. Biopharmaceutical Industry Fellowship Program

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1 MCPHS University and Pfizer Biopharmaceutical Industry Fellowship Program

2 Fast Facts Location : Groton, Connecticut Fellowship Programs Global Clinical Supply : Quality Assurance Length : Two years Requirements : Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy and a US citizen/permanent resident Application deadline January 1st : Contact : 2 PharmDFellowships@Pfizer.com

3 Pfizer Worldwide Research and Development Pfizer strives to improve health and well-being at every stage of life and to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Pfizer s diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world s best-known consumer products. Pfizer s primary areas of focus include immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain, and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with responsibility as the world s leading biopharmaceutical company, Pfizer also collaborates with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on them. Pfizer Biopharmaceutical Industry Fellowship Pfizer Worldwide Research and Development in conjunction with MCPHS University, offers two unique post- PharmD fellowship programs in the following departments: Global Clinical Supply Pharmaceutical Sciences Quality Assurance These programs will provide a comprehensive post doctoral experience that fosters professional growth and develops skills necessary for a successful career in the biopharmaceutical industry. The fellow will not only receive training in the specialty area of the fellowship but will also gain experience in other disciplines within the drug development process. A certificate will be awarded by MCPHS University and Pfizer Worldwide Research and Development upon successful completion of the two-year fellowship. 3

4 Pfizer Global Clinical Supply Global Clinical Supply (GCS) is a global organization that sets the clinical supply strategy, systems, packaging, labeling, logistics and management of quality investigational products to patients in compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards for Pfizer investigational studies. Our Vision: Global excellence in the quality and delivery of medicines to patients. Our Mission: Provide quality medicines and services in a compliant, timely, innovative and cost effective manner. We continuously improve our systems, processes and capabilities in collaboration with our internal and external partners in support of drug development. Our global team will achieve excellence by focusing on patients, working with integrity and professionalism in an enriching work environment. The two-year Post-Doctor of Pharmacy (PharmD) Biopharmaceutical Industry Fellowship will provide insight to the intricacies of the design, plan and execution of clinical trial materials throughout all phases of a drug development program. Fellows will be able to devise strategies to effectively manage clinical supplies from study start up through close out. Portions of the program will be customized to accommodate the individual interests of the fellow. The fellow will participate as an integral member of Global Clinical Supply in a therapeutic area of their choice. GCS Program Design During the first year, the fellow will be exposed to various departments within Research and Development with a focus on global supply chain management of investigational products. The fellow will gain core competency in the following areas: Clinical Supply Strategy and Management Packaging and Labeling Global Distribution Clinical Research Pharmacy Quality Assurance Regulatory Affairs Clinical Development Phase I Clinical Research Unit Clinical Supply Systems and Support Clinical Supply Formulation and Drug Product Development In the second year, the fellow will be assigned a clinical project within a therapeutic area of their interest. The fellow will be expected to apply the knowledge and experience gained within the first year to successfully manage clinical supplies during the second year. At the completion of the fellowship program, the fellow will have established a broad understanding of investigational product processes and how they contribute to the successful conduct of clinical trials and to the safety and well being of patients. GCS Core Objectives Become an integral member of Pfizer Global Clinical Supply including working closely with other Pharmaceutical Sciences Departments, Clinical and Development Operations, Strategic Partners and Quality Assurance Gain in-depth experience across multiple facets of the drug development process for pharmaceuticals, biologics and vaccines from discovery to commercialization Enhance project management, communication and leadership skills Gain hands-on experience in the manufacture of active pharmaceutical ingredient and drug products as well as the packaging, labeling and distribution of investigational products Develop, coordinate and deliver various Disease State Overviews/Clinical Patient Journeys to multidisciplinary Pfizer team members Engage in studies conducted at the Pfizer Clinical Research Unit (New Haven, CT) Learn about the importance of investigational products in the successful execution of a clinical program Design, develop, manage and close out phase I IV clinical trials 4

5 Pfizer Pharmaceutical Sciences Quality Assurance Pharmaceutical Sciences Quality Assurance (PSQA) provides the quality oversight of Pfizer investigational products to maintain clinical trial integrity, ensure regulatory compliance, and protect patient safety. The PSQA organization monitors GMP and works at the GMP/GCP interface to provide quality support for products moving from clinical to commercial manufacture. Our Mission: To be a proactive partner, driving a science & risk-based compliant quality culture that is flexible, innovative and customer oriented, maximizing the contributions of Quality Operations. The two-year fellowship in PSQA focuses on the quality oversight of operations to ensure compliance with global regulatory standards and requirements. The approach will use a unique combination of learning the operational activities as a baseline and moving directly to a supporting Quality Assurance role for the relevant operational function. Fellows will be able to provide GMP quality support for clinical trial materials (small molecules, biological, and vaccines) by learning and participating in the GMP Quality Management System within various groups responsible for supporting early phase clinical studies in humans through post-approval surveillance. PSQA Program Design The first year of the fellowship will be focused on gaining exposure to various divisions within Pfizer, including Research and Development, Global Supply, and Medical in addition to Quality Assurance groups. Although the fellow will be based at the Pfizer Groton, CT site, rotations may also occur at the Andover, MA and Sandwich, United Kingdom locations. The fellow will gain quality core competencies in the following areas: Development and manufacture of small and large molecules for use in clinical trials Packaging, labeling and distribution of investigational products Interactive Response Technology (IRT) use for clinical supply management Responsibility of the Qualified Person in European Union quality oversight Extemporaneous compounding Audits, inspections and vendor management Validation of equipment, facilities, utilities and computerized systems Product complaints and investigations Overview of Quality Management Systems In the second year, the fellow will conduct a project or fulfill a role of significant value to improving the overall quality of investigational products. At the end of the fellowship program, the fellow will have established a broad understanding of quality oversight and processes across the product development lifecycle. PSQA Core Objectives Discover the role, responsibilities and organizational structure of the Pfizer Quality Organization Develop an understanding of the Pfizer Quality Culture Participate in the execution of processes designed to manufacture, package, label and distribute investigational products Gain knowledge of the role of pharmaceutical vendors and how quality is assured Become familiar with PSQA support systems such as standard operating procedures, training, validation, metrics, computerized systems and auditing Understand how to define a strategic quality direction for technology, innovation and new business strategies for Pharmaceutical Sciences Collaborate with members of the Clinical and Medical Quality organizations to ensure delivery of investigational product to clinical sites or review of extemporaneous dosing records and dosage and administration instructions 5

6 Pfizer Fellowship Administration Fellowship Director: Michael T. Ku, PharmD, MBA Dr. Ku is Vice President and Global Head of the Global Clinical Supply organization for Pfizer Worldwide Research and Development located in Groton, CT. Dr. Ku has over 19 years of pharmaceutical and biotech experience, with 15 years in the area of Clinical Research/Clinical Supplies. Prior to joining Pfizer, he was at Genzyme Corporation in Massachusetts. Dr. Ku has a Master s Degree in Business Administration from Anna Maria College, a Doctor of Pharmacy and a Bachelor of Science in Pharmacy from MCPHS University. Dr. Ku also holds a Bachelor of Science in Toxicology from the University of Toronto. GCS Program Leader: Fae Wooding, PharmD, RPh Dr. Wooding is the Senior Manager of Clinical Research Pharmacy within the Global Clinical Supply organization at Pfizer Inc. in Andover, MA. Dr. Wooding has been with Pfizer for over a year and has over 8 years of combined pharmacy experience in academia, hospital, and ambulatory care. Prior to joining Pfizer, she was an Assistant Professor of Pharmacy Practice at MCPHS University. Dr. Wooding has a Bachelor of Science in Human Physiology from Boston University and completed a specialty pharmacy residency in Primary Care at the Providence Veterans Affairs Medical Center after receiving her PharmD from MCPHS University. PSQA Program Leader: Nancy Borgeson Ms. Borgeson is a Director in the Quality Assurance Operation Support Group based at the Pfizer, Groton site, responsible for supporting global operational groups involved in clinical supply packaging, labeling, distribution and IRT system use. She has over 14 years of experience in the pharmaceutical industry in both the Commercial and Clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. Her experience spans roles that include vaccines, parenteral manufacturing, packaging, lyophilization, inventory management, distribution, validation and quality assurance. Prior to her roles in the pharmaceutical industry she held roles in patient care both in the private Physician and Hospital settings. She holds a Bachelor degree in Biology and Business from Oakland University in Rochester Hills, Michigan. 6

7 Current GCS Fellows 2 nd Year Fellow: Jaclynn Ng, PharmD, RPh Dr. Ng received her PharmD in 2012 from MCPHS University and is currently completing the second year of the GCS Fellowship. She also received her Bachelor of Science degree in Biochemistry and Chemistry from the Macaulay Honors College at CUNY College of Staten Island in Dr. Ng has experience in the drug development and delivery process as a bench chemist. She received the Eli Lilly and Company Achievement Award and the Pharmacy Practice Excellence Award from MCPHS in st Year Fellow: John E. O Brien, PharmD Dr. O Brien received his PharmD from the University of Rhode Island, College of Pharmacy in 2013 and is currently completing the first year of the GCS Fellowship. In addition to completing his core pharmacy practice requirements, he completed elective rotations in nuclear pharmacy and academia. 1 st Year Fellow: Luz Shepherd, PharmD, PhD Dr. Shepherd received her PharmD from MCPHS University in 2013 and is currently completing the first year of the GCS Fellowship. Prior to receiving her PharmD, she received a PhD in neurophysiology from the University of Puerto Rico. 7

8 MCPHS University MCPHS University provides an academic environment to guide and support the fellows toward a successful career in the biopharmaceutical industry. As a private institution with a history of specialization 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. MCPHS University faculty and company program leaders mentor fellows according to their scholarly and professional interests throughout the two-year program. As an adjunct assistant professor at MCPHS University, the fellow will have the opportunity to: Develop, coordinate and teach courses at the Boston, Worcester or Manchester campus Co-precept students on advanced experiential rotations Create and publish scholarly research and/or review articles Present research at scientific and clinical meetings Participate in professional development seminars with other Fellows and Resident from MCPHS University affiliated programs 8

9 MCPHS University Fellowship Administration Dean, School of Pharmacy: Michael J. Malloy, PharmD Dr. Malloy oversees the Doctor of Pharmacy program on two campuses Worcester/Manchester, MA and Manchester, NH. Dr. Malloy earned his Doctor of Pharmacy degree from the State University of New York at Buffalo, and completed a residency in cardiology at the University of Florida/VA Medical Center Gainesville, FL. Prior to joining MCPHS University in 1999 as professor and chair, Dr. Malloy held faculty appointments in clinical pharmacy at Memorial University of Newfoundland and Auburn University. Dr. Malloy also has a Bachelor of Science in Chemistry from the University of Miami in Florida, and a Bachelor of Science in Pharmacy from the University of Florida, Gainesville, where he received the Kenneth F. Finger Award for Excellence in Clinical Pharmacy Research. Director of Fellowship Program: Bernard R. Tyrrell, RPh, MBA Mr. Tyrrell is the Director of the MCPHS University Biopharmaceutical Industry Fellowship Program. He serves as Assistant Dean of BA Programs and Non-Thesis Graduate Programs as well as Associate Professor of Social and Administrative Sciences at the University. Prior to joining the University, he spent over 30 years in the industry working for companies like Eli Lilly, AstraZeneca and Johnson and Johnson. Mr. Tyrrell earned a BS in Pharmacy from the Massachusetts College of Pharmacy and holds an MBA in Marketing Management from Bryant University in Smithfield, Rhode Island. Faculty Preceptor: Katie Carey, PharmD Dr.Carey earned her Bachelor of Science in Biology from the University of Massachusetts in 2004 and her Doctor of Pharmacy from Midwestern University College of Pharmacy-Glendale in She completed a postgraduate year one (PGY-1) pharmacy practice residency at Baystate Medical Center in Springfield, Massachusetts in 2009 and a PGY-2 specialty residency in Cardiology Pharmacy Practice at UMass Memorial Medical Center in Worcester, Massachusetts in Dr.Carey is currently an Assistant Professor of Pharmacy Practice at MCPHS University, with a practice in ambulatory care at Baystate Medical Center in Springfield, MA. Dr. Carey is a Board Certified Pharmacotherapy Specialist. Her areas of interest include cardiology, diabetes, and researching the impact that pharmacy students and residents have on patient outcomes. 9

10 The Application Process Compensation and Benefits The fellowship provides a competitive stipend and benefits package, including vacation and comprehensive health insurance. In addition, the fellowship offers an allowance for professional development which includes travel to conferences in pharmacy and other specialty areas. The fellow may qualify for student loan deferment, allowing for the postponement of loan payments until the completion of the fellowship program. The lender of the student loan(s) will be able to provide specific information regarding eligibility and terms of deferment. Eligibility The fellow will be selected through an intensive interview and application process. 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 within the biopharmaceutical industry. Applicants must be a US citizen or have permanent US resident status. Application Interested individuals must submit the following documents: Curriculum vitae Letter of interest Three (3) letters of recommendation Official college transcript Completed applications are accepted from November 1 st to January 1 st. Early submission is highly encouraged due to the competitive nature of the fellow selection process. Electronic copies of the application materials may be submitted; however, a hard copy of the official transcript is required. In addition, electronic letters of recommendation must be sent directly from the recommender s work . All correspondence should be sent to: Michael Ku, PharmD, MBA Vice President Global Clinical Supply Pfizer Inc. Eastern Point Road MS Groton, CT PharmDFellowships@pfizer.com 10

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