Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar 2025

Описание: During this seminar, the CERSI Scholars presented the results of their regulatory science research projects, including studies examining pharmaceutical innovation, medical product safety, leveraging advanced analytics, and much more. This seminar was also opened with a keynote address by Steve Kozlowski, MD, Acting Chief Scientist, FDA. Please see below for the full agenda.

Introduction
Joseph Ross, MD, MHS, Molly Jeffery, PhD (Yale-Mayo Clinic CERSI)

Scholar Presentations
Session 1:
IV Hydration Spas: State Policies and Facility Practices in the U.S. (Anishaa Sivakumar, Yale)
Surveying AI Expert Attitudes on Regulation of Artificial Intelligence Tools in
Medicine (Frank Lee, Mayo Clinic)
Confirmatory Evidence Supporting Single Pivotal Trial New Drug Approvals by FDA (Carla Godoy, Yale)
Co-Pilot Diagnostic Tools for Clinical Trials of Anti-Fibrotic Crohn’s Disease Therapeutics (Garrett Regan, Mayo Clinic)

Session 2:
Strategies to Address and Report Variability Arising from Multiple Analytic Choices in Biomedical Data Analyses: Enhancing Transparency and Reproducibility for Regulatory Decision-Making (Alyssa Columbus, JHU)
New While-Alive Regression Models for Analyzing Composite Survival Endpoints (Xi Fang, Yale)
Implementing the Principal Stratum Strategy for Intercurrent Events in the CALGB 90206 Trial: A Case Study in Oncology Randomized Trial (Xiaoxiao Zhou, Duke)
Partial Principal Ignorability (PPI) Assumption with a Novel Odds Ratio Sensitivity Parameter to Point-Identify PCEs (Jiaqi Tong, Yale)

Session 3:
Sex Differences in Responses to Xylazine, Fentanyl, and Their Combination in Mouse Models of Withdrawal and Respiration (Madigan Bedard, UNC)
Implementation of Postmarketing Requirements and Commitments (Maximilian Siebert, Harvard)
Global Impact of FDA Drug Approval, Major Postmarket Labeling Change, and Withdrawal Determinations (Mengyuan (Cathy) Fu, Yale)
Therapeutic Benefit of the Most Expensive Drugs Covered by Medicare and Medicaid (Tiffany Jiang, Yale)