Real-World Evidence Conference

This fire-side chat brings together leading voices from academia, industry, and FDA—Nancy Dreyer, Sebastian Schneeweiss, Khaled Sarsour, and Marie Bradley—to examine how real-world evidence is evolving for regulatory decision-making including as substantial evidence of effectiveness, and confirmatory evidence in drug approvals, and in safety. The discussion will focus on practical challenges that often determine whether RWE can be used credibly, including data provenance, documentation, transparency, data access, submission constraints, and inspection-readiness. Panelists will also discuss how AI may help scale RWE generation and causal inference while requiring human-in-the-loop checkpoints, clear documentation, and appropriate boundaries. Attendees will leave with practical considerations for designing regulatory-grade RWE strategies that are scientifically rigorous, operationally feasible, and aligned with evolving expectations.