Safety Evaluation, Benefit-Risk Assessment & Pharmacovigilance

Mon, Aug 3, 2:00 PM - 3:50 PM Room CC-203 Thomas M. Menino Convention & Exhibition Center

Ellen SnyderChair

Biopharmaceutical Section

7 Presentations

Benefit-Risk Planning during the Drug Development Phase Begins with the End in Mind

2:05 PM - 2:20 PM

Susan Mayo (FDA)

benefit-risk assessment clinical trial planning

Defining and Evaluating a Patient-Centered Treatment Effect in Clinical Trials

2:20 PM - 2:35 PM

Sean Brummel (Harvard TH Chan School of Public Health)

Co-authors: Soyeon Kim (Frontier Science Foundation), Courtney Yuen (Brigham and Women's Hospital; Harvard Medical School), Bryan Nelson (Harvard University), Emma Davies Smith (Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health), Grace Montepiedra (Harvard TH Chan School of Public Health)

clinical trial risk-benefit patient preferences

Drug-Drug Interaction Detection for Adverse Events in Clinical Trial Safety Data

2:35 PM - 2:50 PM

Sophie Shan (University of North Carolina at Chapel Hill)

Co-authors: Niusha Jafari (Merck & Co.), William Wubao Wang (BARDS, Merck Research Labs), Xianming Tan (University of North Carolina at Chapel Hill), Joseph Ibrahim (University of North Carolina)

Bayesian shrinkage models Drug-drug interaction Safety signal detection

Heterogeneous Risk-Benefit Evaluation with Causal Survival Forests in a Randomized Trial (REPRIEVE)

2:50 PM - 3:05 PM

Emma Davies Smith (Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health)

Co-authors: Virginia Triant (Massachusetts General Hospital), Pamela Douglas (Duke University School of Medicine), Steven Grinspoon (Massachusetts General Hospital), Heather Ribaudo (Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health)

Risk-Benefit Assessment Heterogeneous Treatment Effects Causal Survival Forests Randomized Controlled Trials REPRIEVE HIV

How to reframe a non-inferiority trial as a person-centered superiority comparison using net benefit

3:05 PM - 3:20 PM

Patrick Phillips (University of California, San Francisco)

Generalized pairwise comparisons Non-inferiority Net benefit Equivalence Person-centered outcomes Hierarchical outcomes

Leveraging AI-Based Risk Detection to Strengthen Benefit Risk Justification in Regulatory Submission

3:20 PM - 3:35 PM

Jagannath Ghosh (Medivant Pharma, LLC)

Co-authors: Abhijit Bapat (Sun Pharmaceutical Industries, Inc), Ashok Srivastava (AyurDatta Solutions)

- AI‑Driven Pharmacovigilance FAERS Signal Detection MedDRA‑Based Risk Identification Statistics and clinical evidence-based risk detection Benefit–Risk Assessment Regulatory Safety Evaluation

Priority-Standardized Net Benefit: A Stage-Normalized Estimand for Hierarchical Composite Endpoints

3:35 PM - 3:50 PM

David McCoy (UC Berkeley)

Co-authors: Shirley Galbiati (Edwards Lifesciences), John Leopold (Edwards Lifesciences), Minh Vu, Bonnie Zhang (Edwards LifeSciences, LLC)

hierarchical composite endpoints estimands U-statistics sensitivity analysis patient-reported outcomes (PROs)patient-reported outcomes (PROs)