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Senior Leaders Town Hall
Session Chair(s)
Stella C. Grosser, PhD, MS
Division Director, Office of Biostatistics, OTS, CDER
FDA, United States
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)
Panelist
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
Panelist
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
Panelist
Sylva Heghinian Collins, PhD
FDA, United States
Director, Office of Biostatistics, FDA, CDER
Panelist
Bruce Binkowitz, PhD, MSc
Arcutis Biotherapeutics, Inc., United States
Vice President, Biometrics
Panelist
Pandurang M Kulkarni, PhD
Eli Lilly and Company, United States
Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
Panelist
Sara Hughes
GlaxoSmithKline, United States
Senior Vice President, Biostatistics
Panelist
Amy Xia, PhD
Amgen Inc., United States
Vice President, Center for Design and Analysis
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