ACDRS 2021 Session 1: The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Monday, March 1, 2021 - 10:00 am to Friday, March 5, 2021 - 3:00 pm

This is Session 1 of 6. Must register for the entire course and not per Session.

Session Chairperson:
Charlie T. Gombar, PhD, ACDRS Director
Carl C. Peck, MD, Adjunct Professor, University of California, San Francisco


Daniela Drago, PhD RAC Senior Director, Global Safety & Regulatory Sciences, Biogen
Michael Dyszel Senior Director, Global Program Head, TA POE & CSR, Bayer US LLC
Ellen G. Feigal, MD Partner, NDA Partners LLC
Charlie T. Gombar, PhD ACDRS Director

Kenneth Kaitin, PhD

Professor and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University
David Macarios, MBA Head, Health Economics and Outcomes Research and Payer Engagement, EMD Serono

Bernard Munos

Senior Fellow, FasterCures
Sally Okun, RN MMHS Independent Consultant
Carl C. Peck, MD Adjunct Professor, University of California, San Francisco
Steven Shafer, MD Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
Brian Tseng, PhD MD Vice President, Clinical Development Neurology, Vertex Cell & Gene Therapy
Theo Vos, MD PhD Professor of Global Health, Institute for Health Metrics and Evaluation, University of Washington

Additional faculty - case study proctors

Nicholas Langevin, MS RAC Associate Director, Regulatory Affairs, Boehringer Ingelheim
Kofi A. Mensah, MD PhD Director, Early Clinical Development, Bristol Myers Squibb
Jorge Safi Jr., MD PhD Senior Global Program Safety Lead, Novartis
Lauren Schrier, MBA Vice President, Marketing, Immunovant
Adam Shiell, PharmD Director, Regulatory Affairs, Loxo Oncology, a subsidiary of Eli Lilly & Company


  • History of the pharmaceutical enterprise
  • Development timelines
  • Principles of contemporary drug development and regulatory science
  • Patient perspectives in medical product development
  • Pharmacoeconomics, health technology assessment, and methods for comparison of economic value for different products
  • Global health trends, disease management, and their effect on health outcomes
  • Regulatory pathways for drugs and biologics
  • Regulatory landscape and development challenges in pediatric, cell and gene therapies, and novel treatment modalities
  • Decision points in development of small and large molecules
  • Management science: Portfolio, projects, and teams
  • Target product profile: A key strategic tool in product development
  • COVID-19 trends