ACDRS 2023 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Wednesday, January 25, 2023 - 8:00 am to Friday, January 27, 2023 - 4:00 pm
University of California Washington Center (UCDC), 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

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

Session Co-chairpersons:
Charlie T. Gombar, PhD, ACDRS Director
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners


Daniela Drago, PhD RAC FRAPS FTOPRA  Expert Consultant, NDA Partners
Michael Dyszel  Vice President, Product Development Leader, Pyxis Oncology
Christine Garnett, PharmD Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Center for Drugs and Evaluation Research (CDER), US Food and Drug Administration (to be confirmed)
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 Executive Director, Clinical Trials Transformation Initiative, Duke University
Mary T. Thanh Hai, MD Deputy Director, Clinical, Office of New Drugs, CDER, US FDA (virtual) (to be confirmed)
Theo Vos, MD PhD Professor of Global Health, Institute for Health Metrics and Evaluation, University of Washington
others to be confirmed  

Additional faculty - case study proctors

to be confirmed  


  • 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
  • Special topics based on cutting edge science, changing regulations, controversies, etc.