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 Behring
Jean Lee, PhD, Consultant

Lecturers

CAPT Daniel Brum, PharmD MBA BCPS

 Chief, Project Management Staff, DRONP/ORO/OND/CDER/US Food and Drug Administration
Timothy A. Candy, PharmD MS BCPS Principal Consultant, Regulatory Affairs, Opus Regulatory, Inc.

Charlie T. Gombar, PhD

 ACDRS Director
Elaine Hughes, MBA Vice President, WW Commercial Immunology & Neurology, BMS
Jean Lee, PhD Consultant

Craig H. Mallinckrodt, PhD

Distinguished Biostatistician, Pentara
Eric Moss, MBA

Lead Consultant, Strategic Development & Commercialization, Halloran Consulting Group
Mark Noguchi, MBA Consultant
Alka Shaunik, MD MBA Senior Director, Medical Affairs, CSL Behring

Topics

  • 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