Accelerated Approval Program
30 Years On: Insights and Experiences

March 11, 2022 | 1-4 PM eastern

 

InfographicThe Accelerated Approval Pathway was created by Congress to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. At this virtual public meeting we explored the insights and lessons learned in the 30 years since its inception.

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Agenda

Moderated by Susan C. Winckler, RPh, Esq. 
CEO, Reagan-Udall Foundation for the FDA

1 PM Welcome & Opening Remarks
1:05

Accelerated Approval 1992-2022

  • Accelerated Approval 30 Years On: Lessons and Next Steps
    Jacqueline Corrigan-Curay    , JD, MD, Principal Deputy Center Director, Center for Drug Evaluation and Research, FDA
  • Failure or Success, Results are Essential
    Kevin Fain, JD, MPH, DrPH, Senior Policy Advisor, Office of New Drug Policy, Center for Drug Evaluation and Research, FDA
  • Accelerated Approval in Oncology: 1992-2022
    Gautam Mehta, MD, Clinical Reviewer and Medical Officer, Office of New Drugs, Center for Drug Evaluation and Research, FDA
2:05

Patient Perspective Panel
Moderated by Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

  • Alberto Rubio, MBA
  • Teonna Woolford
  • Navdeep Singh, PhD
  • Katherine Couvillon
3:00

Fireside Chat Sharing Patient Advocacy, Provider, Industry, and Payer Perspectives
Moderated by Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

  • Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer, American Society of Clinical Oncology
  • Kay Holcombe, MS, Board Chair, National Organization for Rare Disorders
  • Michelle McMurry-Heath, MD, PhD, President & CEO, BIO
  • Michael Sherman, MD, MBA, Chief Medical Officer, Point 32 Health
3:55 Closing Remarks/Adjourn

Speaker & Moderator Biographies