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Benefit-Risk Evaluation in Drug Development

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
397

Room Number:
7A

Level:
Intermediate

Type:
Session

Title:
Benefit-Risk Evaluation in Drug Development

Chair(s):
Qi Jiang, PhD
Executive Director, Global Biostatistical Science
Amgen Inc., United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Structured Benefit-Risk Assessment Across the Life Cycle of Products: Methods, Examples and Challenges
George Quartey, PhD, MSc
Principal Statistical Scientist, Biostatistics
Genentech, A Member of the Roche Group, United States

Current Benefit-Risk Practice: What Has Resonated, What Has Not?
Andreas I. Sashegyi, PhD
Senior Research Advisor, Statistics
Eli Lilly and Company, United States

Uncertainty in Benefit-Risk Assessment
Qi Jiang, PhD
Executive Director, Global Biostatistical Science
Amgen Inc., United States