Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2025 Session 6 - Integrated Product Development, Portfolio Management, Project Management, and Preparing for Transition to the Market
Date:
Wednesday, October 22, 2025 - 8:00 am to Friday, October 24, 2025 - 4:00 pm
Location:
Location: University of California Washington Center (UCDC), 1st floor meeting room
1608 Rhode Island Ave NW, Washington DC
This is Session 6 of 6. Must register for the entire 2025 Course and not per session.
Session 6 Co-chairpersons:
Charlie Gombar, PhD, ACDRS Director
Michael Dyszel, Project Excellence Lead, CSL Behring
Jean Lee, PhD, Consultant
Lecturers
Charlie T. Gombar, PhD |
ACDRS Director |
Jean Lee, PhD | Consultant |
others to be confirmed |
Topics (subject to change)
- Portfolio management: principles, challenges, applications, and strategies
- Role of licensing in portfolio management
- Project management: principles, challenges, and strategies
- Judgment under uncertainty
- Integrated global strategy
- Turning strategy into plans
- Co-development and alliances
- Strategic marketing (commercial) role in development
- How to launch a new drug successfully into the market
- Risk communication and prescription drug promotion
- Promotional committee review simulation
- Leadership strategies in drug development and regulation
- Integrated evidence generation planning
- US Food and Drug Administration Management of the Review Process