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Benefit-Risk Evaluation in Drug Development
Session Chair(s)
Qi Jiang, PhD
Executive Director, Global Biostatistical Science
Amgen Inc., United States
This session will evaluate various potential systematic benefit-risk assessment approaches to cover the needs of global regulatory agencies and governance bodies, along with the application of the methods. This session was developed in conjunction with the Quantitative Sciences in Pharmaceutical Industry (QSPI) Benefit-Risk Working Group.
Learning Objective : Discuss the key existing benefit-risk methods; List recommended methods from statisticians in the Quantitative Sciences in Pharmaceutical Industry (QSPI) Benefit-Risk Working Group; Describe best practice sharing on benefit-risk assessment implementation.
Speaker(s)
Structured Benefit-Risk Assessment Across the Life Cycle of Products: Methods, Examples and Challenges
George Quartey, PhD, MSc
Genentech, A Member of the Roche Group, United States
Scientific Enablement Leader
Current Benefit-Risk Practice: What Has Resonated, What Has Not?
Andreas I. Sashegyi, PhD
Eli Lilly and Company, United States
Senior Research Advisor, Statistics
Uncertainty in Benefit-Risk Assessment
Qi Jiang, PhD
Amgen Inc., United States
Executive Director, Global Biostatistical Science
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