ACDRS 2024 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Wednesday, January 17, 2024 - 8:00 am to Friday, January 19, 2024 - 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 2024 Course and not per session.

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


(subject to change)

  • 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.