Medical Affairs

Medical Affairs Professional Society MAPS is the premier non-profit global Medical Affairs organization FOR Medical Affairs professionals BY Medical Affairs professionals across all different levels of experience/specialty to engage, empower and educate. Together with over 9,000 Medical Affairs members from 280+ companies globally, MAPS is transforming the Medical Affairs profession to increase its value to patients, HCPs and other decision makers. Dr. Kirk Shepard has more than 25 years of experience in the pharmaceutical industry. He is a board-certified medical oncologist and hematologist physician. He is currently Chief Medical Officer, Senior Vice President, Head of Global Medical Affairs OBG at Eisai Pharmaceutical Company. Dr. Shepard’s experience in multiple therapeutic areas includes operational and strategic product development from Phases I through IV and the diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, health economics & outcomes research & patient access, data generation, field-based medical teams (MSLs), PV/safety, medical communication & publications, patient advocacy, and public relations. In 2015, he was selected as one of the 100 Most Inspiring People in the Pharmaceutical Industry (PharmaVOICE). Before his pharmaceutical career, Dr. Shepard served as a staff physician in the Department of Hematology and Medical Oncology at the Cleveland Clinic Foundation, where he supervised numerous studies in oncology and symptom control. He has more than 50 medical publications in journals and books. Dr. Shepard earned his bachelor’s degree from Cornell University in Ithaca, NY, and his medical degree from the University of Cincinnati Medical School in Cincinnati, OH. He completed both his internship and residency in internal medicine at Case Western Reserve University in Cleveland, OH, and fellowships in hematology and oncology at the University of Chicago Hospitals and Clinics in Chicago, IL. Charlotte M. E. Kremer, MD, MBA is formerly the Executive VP and Head of Medical Affairs for Astellas, recently retired. In this role, Dr. Kremer provided leadership for the Medical Affairs organization globally. Dr. Kremer joined Astellas in 2012 with 20 years of experience in the pharmaceutical industry. Prior to Astellas, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer. While at Pfizer, she successfully led and executed the clinical development and global medical programs in these respective areas. Prior to joining Pfizer, Dr. Kremer held positions of increasing responsibility providing medical support, developing Phase 3b/4 clinical trials, and initiating and directing a Medical Liaison program at Organon Pharmaceuticals, both in the Netherlands and in the United States. A native of the Netherlands, Dr. Kremer received her medical degree from the University of Utrecht, The Netherlands. She went on to receive her Diploma Pharmaceutical Medicine (DPM) from Universite Libre de Bruxelles. After transferring to the United States, Dr. Kremer completed the Executive MBA program at New York University’s Leonard N. Stern School of Business. Garth Sundem is Director of Communications & Marketing with the Medical Affairs Professional Society (MAPS). Previously, he was Science Writer and then Communications Manager for the University of Colorado Cancer Center, writing more than 500 articles on topics ranging from basic science to cancer survivorship. Garth has written and ghostwritten more than a dozen mass-market books for publishers including Crown, Three Rivers, Ben Bella, Workman Publishing and Free Spirit Press, on topics including math humor, pop science, and psychology (full list at Amazon). He has been featured on Good Morning America, NPR, CBS, BBC and the Discovery Channel (among others), has written for outlets including the New York Times, WIRED, Scientific American, Sky & Telescope and Men’s Health (among others), and was a core contributor at sites including GeekDad.com and PsychologyToday.com. He graduated summa cum laude from Cornell University.

SECTION 1: MEDICAL AFFAIRS IN THE PHARMACEUTICAL AND MEDTECH INDUSTRIES

Chapter 1 What Is Medical Affairs?

Chapter 2 Groups and Structure of Medical Affairs

Chapter 3 Medical Affairs Collaborations Across the Drug/Device Development Lifecycle

Chapter 4 Measuring the Impact of Medical Affairs

Chapter 5 Medical Affairs Careers

SECTION 2: THE PRACTICE OF MEDICAL AFFAIRS

Chapter 6 Medical Strategy and Launch Excellence

Chapter 7 Evidence Generation and Real-World Evidence

Chapter 8 Medical Communications

Chapter 9 External Education

Chapter 10 Field Medical

Chapter 11 Insights

Chapter 12 Medical Information

Chapter 13 Patient Centricity

Chapter 14 Medical Operations

Chapter 15 Digital Strategy

Chapter 16 Compliance

Chapter 17 Rare Disease and Gene Therapy

Chapter 18 Medical Affairs in MedTech