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

Full map

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