Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2024 Session 6 - Integrated Product Development, Portfolio Management, Project Management, and Preparing for Transition to the Market
Date:
Wednesday, October 16, 2024 - 8:00 am to Friday, October 18, 2024 - 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 2024 Course and not per session.
Session 6 Co-chairpersons:
Charlie Gombar, PhD, ACDRS Director
Michael Dyszel, Project Excellence Lead, CSL Bering
Jean Lee, PhD, Consultant
Lecturers
TImothy A. Candy, PharmD MS BCPS | Principal Consultant, Regulatory Affairs, Opus Regulatory, Inc. |
Michael Dyszel | Vice President, Product Development Leader, Pyxis Oncology |
Charlie T. Gombar, PhD |
ACDRS Director |
Elaine Hughes, MBA | Vice President, WW Commercial Immunology & Neurology, BMS |
Jean Lee, PhD | Consultant |
Craig H. Mallinckrodt, PhD |
Senior Vice President, Statistics, Cortexyme |
Mark Noguchi, MBA | Consultant |
Alka Shaunik | Senior Director, Medical Affairs, CSL Bering |
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