MCPHS University and Pfizer Biopharmaceutical Industry Fellowship Program 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 healthcare 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 healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare 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 Programs Pfizer Worldwide Research and Development in conjunction with Massachusetts College of Pharmacy and Health Sciences (MCPHS University), offers three unique post-PharmD fellowship programs in the following departments: •Global Clinical Supply •Pharmaceutical Sciences Quality Assurance Each two year fellowship program 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 fellowship. 1 Global Clinical Supply (GCS) 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. 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. There are two fellowship programs offered within the GCS organization: • Clinical Supply Chain Strategy and Management • Clinical Research Pharmacy Each program is two years in length and designed to enhance the fellow’s understanding of the drug development process from molecule inception to commercialization. In addition, the fellow will gain insights to the intricacies of the design, planning, and execution of clinical supplies throughout all phases of development. See below for the unique descriptions of each fellowship program. Clinical Supply Chain Strategy and Management GCS Program Design This two year fellowship focuses on application of clinical supply strategies to effectively manage pharmaceuticals, biologics, and vaccine-based investigational products in global clinical trials from study start up to completion. 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. Clinical Research Pharmacy This two year fellowship focuses on the development and implementation of patient focused tools to optimize the use of investigational products, with an emphasis on patient adherence. The fellow will be expected to apply the knowledge gained in the first year to design strategies for monitoring, evaluating, and improving patient adherence in clinical trials. During the first year, both fellows will rotate through various departments within Research and Development to gain an understanding of the drug development process from molecule inception to commercialization. Fellows will gain core competency in the following areas: • • • • • • • • • • linical Supply Strategy and Management C 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 Design In the second year, the fellows will be assigned a clinical project within the scope of their fellowship focus. GCS Core Objectives • B ecome 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 2 Pharmaceutical Sciences Quality Assurance (PSQA) 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. Phamaceutical 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 Good Manufacturing Practice (GMP) and works at the GMP/Good Clinical Practice (GCP) interface to provide quality support for products moving from clinical to commercial manufacture. 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 Note: Recruitment for the fellowship program in Quality Assurance occurs biennially every odd-numbered year. 3 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 20 years of pharmaceutical and biotech experience, with 16 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 two years and has over 10 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 Operations Support Group based at Pfizer, Inc. in Groton, CT responsible for supporting global operational groups involved in clinical supply packaging, labeling, distribution and IRT system use. She has over 15 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. 4 PSQA Fellowship Coordinator PSQA Program Coordinator: Matthew Opalenik Mr. Opalenik is a Senior Manager in the Quality Assurance Group based at the Pfizer Groton site. He has over 25 years of experience in the pharmaceutical industry in R&D, commercial, contract manufacturing and consulting areas. His experience spans QA and IT support with an emphasis on computerized systems and validation. He holds a Bachelors of Science degree in Physics from the University of Akron in Akron, Ohio. Current Fellows 2nd Year GCS 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 second year of the GCS Fellowship. In addition to completing his core pharmacy practice requirements, he completed elective rotations in nuclear pharmacy and academia. 2nd Year GCS Fellow: Luz Shepherd, PharmD, PhD Dr. Shepherd received her PharmD from MCPHS University in 2013 and is currently completing the second year of the GCS Fellowship. Prior to receiving her PharmD, she received a PhD in neurophysiology from the University of Puerto Rico. 5 Current Fellows (Continued) 1st Year GCS Fellow: Adam Craig, PharmD Dr. Craig is originally from Plainfield, IN and received his PharmD from Purdue University in 2014. Dr. Craig is currently completing the first year of the GCS Fellowship, and prior to the fellowships he completed rotations in Academia, Industry, and traveled to Kenya, Africa for a two month inpatient elective. 1st Year PSQA Fellow: Jacob Mattox, PharmD, BA Dr. Mattox received both his PharmD and Bachelor of Arts in Spanish from Purdue University in 2014 and is the first pharmaceutical fellow in the PSQA Fellowship Program. In 2014, Dr. Mattox completed stewardship rotations in Managed Care, Drug Information, and Pharmacovigilance. He is a recipient of the 2014 Purdue University Patient Care Award for his efforts during his experiential year. Dr Mattox also serves on the Purdue Alumni Board of Directors as the Class of 2014 representative. 6 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 residents from MCPHS University affiliated programs 7 MCPHS University Fellowship Administration 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. Program Coordinator: Abir Kanaan, PharmD Dr. Kanaan is an Associate Professor of Pharmacy Practice at MCPHS University. She joined the University in 2005 after completing a postgraduate pharmacy practice residency at UMass Memorial Medical Center. Dr. Kanaan holds an adjunct faculty appointment in the Department of Medicine at the University of Massachusetts Medical School and is also affiliated with the Meyers Primary Care Institute where she is involved in several research projects pertaining to medication safety in the outpatient setting with specific focus on the elderly. Dr. Kanaan also serves as a codirector for the Pharmacy Medication Safety, Quality, and Informatics Fellowship program at Saint Vincent Hospital in Worcester, MA. 8 MCPHS University Faculty Preceptors Faculty Preceptor: Katherine 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 2008. 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 2010. 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. Faculty Preceptor: Cheryl Durand, PharmD Dr. Durand graduated from Northeastern University in 2002. Since graduation Cheryl has been a hospital clinical pharmacist. Currently she works full time at MCPHS University as an associate professor of pharmacy practice with a focus in infectious disease and pharmacy advocacy and leadership. At MCPHS she is a preceptor for Institutional APPE students. At Elliot Hospital, she precepts residents in the longitudinal teaching elective rotation. Additionally, she works for Elliot Hospital as a per diem pharmacist. She currently serves on the New Hampshire (NH) Board of Pharmacy Continuing Education Advisory Council and is currently the Vice President of the organization. Cheryl is also a recipient of the Trustees Award for Teaching Excellence at MCPHS University. Faculty Preceptor: Paul Belliveau, PharmD Dr. Belliveau earned his Bachelor of Science in Pharmacy from the University of Rhode Island in 1988 and his Doctor of Pharmacy from MCPHS University-Boston in 1991. He completed an Antibiotic Management Fellowship at Hartford Hospital in Hartford, Connecticut in 1993. Dr. Belliveau is currently Professor and Chair of Pharmacy Practice at MCPHS School of Pharmacy – Worcester/Manchester. Dr. Belliveau’s areas of interest include infectious diseases, pharmacokinetics, academic leadership, and pharmacy education. 9 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, each with a Recommendation Request Form • Official college transcript Completed applications are accepted from November 1st to January 1st. 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 e-mail. All correspondence should be sent to: Michael Ku, PharmD, MBA Vice President, Global Clinical Supply Pfizer Inc. Eastern Point Road MS 8220-2255 Groton, CT 06340 E-mail: PharmDFellowships@pfizer.com 10 Fellowship At-A-Glance Location : Groton, Connecticut Fellowship Programs : Clinical Supply Chain Strategy and Management Clinical Research Pharmacy 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 :PharmDFellowships@Pfizer.com 2014 MCPHS University/Pfizer Fellows 11 For more information about the fellowship programs, please scan the QR code above. Pfizer, Groton, CT 12 14