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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Senior Leaders Town Hall

Session Chair(s)

Stella C. Grosser, PhD, MS

Stella C. Grosser, PhD, MS

  • Division Director, Office of Biostatistics, OTS, CDER
  • FDA, United States
Lisa  Lupinacci, PhD, MS

Lisa Lupinacci, PhD, MS

  • Senior Vice President, Biostatistics and Research Decision Sciences
  • Merck and Co., Inc., United States
This session will provide an opportunity for attendees to hear senior leaders’ thoughts on topics relevant to today’s drug development environment. There will be several topics introduced for discussion, and the senior leaders will provide comments. There will also be an opportunity for attendees to ask questions of specific panel members or the entire panel.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss statistical leadership during the COVID-19 pandemic to comprehend clinical trial issues and influence revisions
  • Explain perspectives on the decentralization of clinical trials during the COVID-19 pandemic and describe how revisions might impact statistical issues
  • Identify areas where statisticians could benefit from further leadership training to prepare for upcoming challenges


    Andrew  Thomson, PhD, MA, MS


    Andrew Thomson, PhD, MA, MS

    • Statistician, Methodology Taskforce
    • European Medicines Agency, Netherlands
    John  Scott, PhD, MA


    John Scott, PhD, MA

    • Director, Division of Biostatistics, OBPV, CBER
    • FDA, United States
    Sylva  Collins, PhD


    Sylva Collins, PhD

    • Director, Office of Biostatistics, OTS, CDER
    • FDA, United States
    Bruce  Binkowitz, PhD, MSc


    Bruce Binkowitz, PhD, MSc

    • Vice President, Biometrics
    • Shionogi, Inc., United States
    Pandurang M Kulkarni, PhD


    Pandurang M Kulkarni, PhD

    • Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
    • Eli Lilly and Company, United States
    Sara  Hughes


    Sara Hughes

    • Senior Vice President, Biostatistics
    • GlaxoSmithKline, United States
    Amy  Xia, PhD


    Amy Xia, PhD

    • Vice President, Center for Design and Analysis
    • Amgen Inc., United States