FDA - PDS Symposium IX: Agenda

Welcome

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

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

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

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

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.

Call to Action & Next Steps

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