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Session 7: Quantitative Measures for Benefit-Risk Assessment
Session Chair(s)
Ram Tiwari, PhD, MS
Head of Statistical Methodology
Bristol Myres Squibb , United States
Frank W. Rockhold, PhD, MSc
Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States
Panelists (joining the Speakers)
Speaker(s)
Quantitative Structured Benefit-Risk: The Current, the New and the Future
Ian Hirsch, PhD
Astrazeneca, United Kingdom
Respiratory/Infection Biologics and Vaccine Products Biometrics Strategy Lead
Bayesian Approaches to Quantitative Benefit-Risk Assessment: A Perspective for Better Decision Making
Yueqin Zhao, PhD
FDA, United States
Lead Mathematical Statistician, OB, OTS, CDER
Benefit-Risk Approaches for Hypothetical Risk
Marilyn A. Metcalf, PhD
GlaxoSmithKline, United States
Senior Director, Patient Focused Development, Global Medical
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Christy Chuang-Stein, PhD
Chuang-Stein Consulting, LLC, United States
Vice President, Head of Statistical Research and Consulting Center
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