FDA - PDS Symposium IX: Agenda

Event Agenda

Wednesday, October 7, 2020 | 12:00 - 3:00 PM (EDT)


12:00 - 12:10 PM (EDT)


  • Bill Louv, PhD, President; Project Data Sphere
  • Julia Beaver, MD, Chief of Medical Oncology, Oncology Center of Excellence; US Food and Drug Administration
12:10 - 12:40 PM

Keynote: Rare cancer registries – Impact on clinical practice, drug development and regulators

  • David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine, Translational Medicine & Human Genetics; University of Pennsylvania
12:40 - 1:25 PM

Panel 1: How do rare cancer registries impact clinical decision making?

Moderator: Dave Reese, MD, Executive Vice President of Research & Development; Amgen, Inc.

  • David Miller, MD, Medical Oncologist; Massachusetts General Hospital
  • Gregory Reaman, MD,  Associate Director, Pediatric Oncology, Oncology Center of Excellence; US Food and Drug Administration
  • Ting Yu, MD, MS, Medical Director; EMD Serono, a business of Merck KGaA, Darmstadt Germany

Questions and Answers

    1:30 - 2:15 PM

    Panel 2: How do rare cancer registries advance drugs in development?

    Moderator: Zhen Su, MD, MBA, Senior Vice President, Head of US & Global Oncology Franchise; EMD Serono, a business of Merck KGaA, Darmstadt Germany

    • Martha Donoghue, MD, Pediatric Solid Tumors Scientific Liaison; US Food and Drug Administration
    • Gregory Friberg, MD, Vice President Global Development, Therapeutic Area Head Heme/Onc & Bone; Amgen, Inc.
    • Michael Wong, MD, PhD, FRCPC, Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine; The University of Texas MD Anderson Cancer Center

    Questions and Answers

      2:15 - 2:40 PM

      Fireside Chat: Generating clinical evidence for biomarker-driven indications

      Sean Khozin, MD, MPH, Vice President, Global Head of Data Strategy; Janssen Research & Development, LLC, to interview Josh Bilenker, MD, Chief Executive Officer; Loxo Oncology, Inc.

      2:40 - 2:50 PM

      Call to Action & Next Steps

      • Andy Crighton, MD, Chief Executive Officer; CEO Roundtable on Cancer and Project Data Sphere