1st Edition

Medical Affairs The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries

Edited By Kirk V. Shepard, Charlotte Kremer, Garth Sundem Copyright 2024
    264 Pages 113 Color Illustrations
    by CRC Press

    Medical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles.

    Features:

    • Defines the purpose and value of Medical Affairs and provides clear career paths for scientific experts seeking their place within the pharmaceutical and MedTech industries.
    • Provides guidance and baseline competencies for roles within Medical Affairs including Medical Communications, Evidence Generation, Field Medical, Compliance, and many others.
    • Specifies the "true north" of the Medical Affairs profession as ensuring patients receive maximum benefit from industry innovations including drugs, diagnostics and devices.
    • Presents the purpose and specific roles of Medical Affairs roles across organization types including biotechs, small/medium/large pharma and device/diagnostic companies, taking into account adjustments in the practice of Medical Affairs to meet the needs of developing fields such as rare disease and gene therapy.
    • Leverages the expertise of over 60 Medical Affairs leaders across companies, representing the first unified, global understanding of the Medical Affairs profession.

    SECTION 1: MEDICAL AFFAIRS IN THE PHARMACEUTICAL AND MEDTECH INDUSTRIES

    Chapter 1 What Is Medical Affairs?

    Kirk Shepard, Charlotte Kremer, Robin Winter-Sperry, Danie du Plessis and Peter Piliero

    Chapter 2 Groups and Structure of Medical Affairs

    Victoria Elegant, Greta James-Chatgilaou, Darryl Sleep and Bagrat Lalayan

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

    Tamas Koncz, Gail Cawkwell and Liviu Niculescu

    Chapter 4 Measuring the Impact of Medical Affairs

    Anna Walz, Paul Tebbey, Jovanka Paunovich and Joe Kohles

    Chapter 5 Medical Affairs Careers

    Peter Piliero, Jim Alexander, Danny McBryan, Patrick Reilly, Wendy Fraser and Charlotte Raabe-Hielscher

    SECTION 2: THE PRACTICE OF MEDICAL AFFAIRS

    Chapter 6 Medical Strategy and Launch Excellence

    Meg Heim, Rachele Berria, Loubna Bouarfa, Deb Braccia, Shontelle Dodson, Andrew Greenspan, Deborah Long, Ameet Nathwani, Tam Nguyen, Holly Schachner, Roz Schneider, Ajay Tiku, Rebecca Goldstein and Stephanie Wei

    Chapter 7 Evidence Generation and Real-World Evidence

    Ann Hartry, Charlotte Kremer, Judith Nelissen, Omar Dabbous, Suzanne Giordano and Kristine Healey

    Chapter 8 Medical Communications

    Renu Juneja, Rob Mattheis, Sandrine Jabouin and Noreen Hussein

    Chapter 9 External Education  

    Shontelle Dodson, Kirtida Pandya, Marleen van der Voort, Maureen Doyle-Scharff and Kimberly Braithwaite

    Chapter 10 Field Medical

    Robin Winter-Sperry, Kathy Gann, Suzanne Giordano, Lori Mouser and Rich Swank

    Chapter 11 Insights

    Sandra Silvestri, Siobhan Mitchell, Dr Mónica de Abadal, Catrinel Galateanu and Monique Furlan

    Chapter 12 Medical Information

    Evelyn R. Hermes-DeSantis, Stacey Fung, Kristin Goettner, Christopher J. Keenan, Marie-Ange Noue and Jill Voss

    Chapter 13 Patient Centricity

    Danie du Plessis, Oleks Gorbenko, Isabelle Bocher-Pianka, Tricia Gooljarsingh, Karen King and Roslyn F. Schneider

    Chapter 14 Medical Operations

    Suzana Giffin, Bjorn Oddens, George Betts, Søren Buur, Arnaud Gatignol and Sokhon Bouy

    Chapter 15 Digital Strategy

    Rishi Ohri, Sarah Clark and Richard Kemper

    Chapter 16 Compliance

    Maureen J. Lloyd and Jessica Santos

    Chapter 17 Rare Disease & Gene Therapy

    Nikolai Nikolov, Leonard A Valentino and Tricia Gooljarsingh

    Chapter 18 Medical Affairs in MedTech

    William Sigmund, John Pracyk, Tobi Karchmer, Joao D. Dias, Klaus Hoerauf, Idal Beer, David Macarios, Bill Altonaga, Greg Christopherson, Ann Ford, Dee Khuntia, Sean Lilienfeld, Mark Miller, Hany Moselhi, Ross "Rusty" Segan and Ronald Silverman

    Biography

    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.