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Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Session Chair(s)
Graham Thompson
Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States
FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.
Learning Objective : Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.
Speaker(s)
Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Director, Patient Preference Evidence Generation, Pfizer, United States
CBER’s Experience with Benefit-Risk
Biologist, OBPV, CBER, FDA, United States
Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Senior Mathematical Statistician, CDER Office of Biostatistics, FDA, United States
Best Practices for Quantitative Benefit-Risk Assessments
Managing Director and Chief Scientist, Kielo Research, Switzerland
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