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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

    Speaker(s)

    Andrew Thomson, PhD, MA, MS

    Panelist

    Andrew Thomson, PhD, MA, MS

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

    Panelist

    John Scott, PhD, MA

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

    Panelist

    Sylva Collins, PhD

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

    Panelist

    Bruce Binkowitz, PhD, MSc

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

    Panelist

    Pandurang M Kulkarni, PhD

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

    Panelist

    Sara Hughes

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

    Panelist

    Amy Xia, PhD

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

    Contact us

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    1.888.257.6457

    Preconference Short Courses

    Short Course 1: Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making

    Short Course 2: Statistical Analyses Targeting Estimands