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Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation

Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation

Friends of Cancer Research Virtual Meeting

Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation

Thank you to all that attended! To watch the meeting again in full, please click HERE.
Click HERE to read our pre-meeting blog posts on our work.
Click here to read the Meeting White Paper

Monday, September 20, 2021
12:00PM EDT – 1:00PM EDT

Friends of Cancer Research (Friends) is proud to announce a new virtual meeting, Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation. Breakthrough therapy designation is a process designed to expedite the development and review of drugs that are intended to treat serious conditions. In oncology, the ability to target a novel agent against key drivers of cancer has led to several therapeutic breakthroughs in serious, life-threatening diseases with limited or no systemic treatment options for cancer patients. These breakthroughs have established new classes of therapeutics leading to, in some instances, unprecedented efficacy results.

This workshop will discuss best practices for optimizing interactions between the FDA and Sponsor to facilitate development of emerging new therapies and provide appropriate and timely access for patients.

Click HERE to read the first post from our pre-meeting blog series.

Register for the meeting above and stay tuned for additional agenda updates. The current draft agenda is below.

Draft Agenda

12:00PM – Welcome & Introductions

12:03PM – Opening Keynote

  • Sen. Michael Bennet (D-CO)

12:06pm – Panel 1: Personalizing the “All-Hands-on-Deck” Approach

  • Moderator: Bea Lavery, Genentech Roche
  • Martha Donoghue, U.S. FDA
  • Tina Kim Hafken, Seagen
  • Nam Atiqur Rahman, U.S. FDA
  • Giuseppe Randazzo, Novartis

12:34pm – Panel 2: Modernizing Expedited Drug Development for Future Capacity and Sustainability

  • Moderator: Nicholas Florko, STAT News
  • Katherine Couvillon, Patient Advocate
  • Sandra Horning, Stanford University; Fmr. Genentech Roche
  • Michelle McMurry-Heath, BIO
  • Richard Pazdur, Oncology Center of Excellence, U.S. FDA

12:58PM – Closing Remarks