ACDRS 2026 Session 6: Integrated Product Development, Project Management, Portfolio Management, & Preparing for Transition to Market

Integrated Product Development, Project Management, Portfolio Management, & Preparing for Transition to Market

 

Details

About

Must be registered in advance to attend.

Session Co-chairs: Charlie T. Gombar, PhD, ACDRS Director & Jean Lee, PhD, Lee PPM Biopharma Advisory Services

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

Speakers

  • Dan Brum, PharmD MBA BCPS RAC, Program Coordinator, Center for Drug Evaluation and Research, US FDA (to be confirmed)
  • 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 & Neuroscience, BMS
  • Andy Lee, Retired SVP & Head of Global Clinical Trial Operations, Merck
  • Jean Lee, PhD, Portfolio & Program Management Independent Advisor, Lee Biopharma Advisory Services, Lee Biopharma Advisory Services LLC
  • Craig H. Mallinckrodt, PhD, Distinguished Biostatistician, Pentara
  • Eric Moss, MBA, Senior Director, Portfolio Decision Science, Lundbeck
  • Mark Noguchi, MBA, Consultant
  • Alka Shaunik, MD MBA, Senior Vice President, Head of Medical Affairs, Catalyst Pharmaceuticals