FDA - PDS Symposium X: Agenda

Event Agenda

Thursday, September 23, 2021 | 1:00 - 4:00 PM (EDT)


1:00PM (EDT)

Welcome from the FDA and Project Data Sphere

  • Dr. Bill Louv, PhD, President; Project Data Sphere
  • Donna R. Rivera, PharmD., MSc, Associate Director of Pharmacoepidemiology; US Food and Drug Administration (FDA)

Keynote Address

  • Dr. Robert Califf, MD, MACC, Head of Clinical Policy and Strategy; Verily Life Sciences and Google Health

Panel 1: Routes to Yes

(balance of incentives, patient consent, access, responsible science) 


  • Moderator: Dr. Atul Butte, MD, PhD, Director; University of California, San Francisco (UCSF)
  • Panelist: Najat Khan, PhD, Chief Data Science Officer, Janssen R&D Data Sciences Global Head, Janssen R&D Strategy & Operations; Janssen Pharmaceutical Companies of Johnson & Johnson
  • Panelist: Dr. Harlan Krumholz, MD, SM, Harold H. Hines, Jr. Professor of Medicine; Yale School of Medicine
  • Panelist: Professor Steven Kern, PhD, Deputy Director, Quantitative Sciences; Bill & Melinda Gates Foundation

Followed by questions and answers


Panel 2: Sustainability Practices in Sharing and Reuse 

(beacon stories and positive forces making data accessibility and reuse possible)


  • Moderator: Dr. David Chambers, DPhil., Deputy Director for Implementation Science in the Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS); National Cancer Institute (NCI)
  • Panelist: Dr. Frank Rockhold, PhD, Professor of Biostatistics and Bioinformatics; Duke Clinical Research Institute, Duke University Medical Center
  • Panelist: Dr. Jaime Guidry Auvil, PhD, Director, Office of Data Sharing; National Cancer Institute (NCI)
  • Panelist: Dr. Yili Pritchett, PhD, Vice President, Head of Biometrics; G1 Therapeutics Inc

Followed by questions and answers


    Fireside Chat


    • Interviewer: Dr. Corrie Painter, PhD, Deputy Director; Count Me In, Broad Institute
    • Guest: Dr. Ned Sharpless, M.D., Director; National Cancer Institute (NCI)
    • Guest: Dr. David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine; University of Pennsylvania

    Patient Power: The Untapped Resource for Accelerating Discovery

    • Sue Sherman, MHA, Executive Director & CEO; The LAM Foundation
    • Andrea Slattery, Director of Research; Symmetry Peak Management