Kimberly Chew will co-present, "Psychedelics, Protocols, and Prompts: Navigating Regulatory Rigor and AI-Enabled Review in the Next Wave of Psychedelic Therapeutics," at The Sixth Annual Psychedelics Therapeutics & Drug Development Conference on Friday, February 27, 2026.
This session will explore how evolving regulatory expectations—such as durability of effect, bias control, endpoint integrity, and psychotherapy standardization—are impacting late-stage development of psychedelic therapeutics. It will also address how the FDA’s increasing use of AI is transforming submission review processes. Using recent case studies, the session will provide practical guidance for sponsors on trial design, preparing AI-ready filings, and managing regulatory risks in an AI-driven environment.
For more information, visit the event website.