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Session 3 - Benefit-Risk Assessment: Foundations and Emerging Frontiers
Session Chair(s)
John Scott, PhD, MA
Division Director, Office of Biostatistics, CBER
FDA, United States
Drug development and regulatory decision-making have long been guided by informal weighing of the benefits and risks of medical treatments. Due in part to new regulatory initiatives, formal benefit-risk assessments are increasingly important to industry and regulatory stakeholders. Statisticians play a key role in benefit-risk assessment, helping to develop and implement explicitly quantitative benefit-risk methodologies, as well as providing input to more qualitative approaches. In this session, we will hear from three benefit-risk experts: an FDA representative, who will provide an overview of the current regulatory environment for benefit-risk assessment and ongoing initiatives; a member of the QSPI Benefit-Risk Working Group, who will discuss existing methodologies for benefit-risk assessment; and a representative from industry, who will present a case study applying a benefit-risk assessment in a regulatory filing.
Speaker(s)
Qi Jiang, PhD
Amgen Inc., United States
Executive Director, Global Biostatistical Science
Benefit-risk Assessment Across the Lifecycle of Products: Methods and Challenges
Chunlei Ke, PhD
Amgen Inc., United States
Evaluation of Benefit and Risk
Ellis Unger, MD
Hyman, Phelps & McNamara, P.C., United States
Principal Drug Regulatory Expert
Carmen Bozic, MD, PhD
Biogen, United States
SVP, Portfolio Transformation
Panelist
Thomas J. Permutt, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
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