Kimberly Chew was invited to speak at RBC Capital Markets’ Mini-Symposium session on “Regulatory Insights Shaping the Psychedelics Landscape,” where she shared perspectives on the evolving regulatory environment for psychedelic therapies.
During the session, Ms. Chew addressed key topics including the complexities of DEA rescheduling at both the federal and state levels, the implications of the FDA’s 2023 draft guidance on psychedelic drug development, and the harmonization of global regulatory standards. She also discussed challenges such as maintaining study integrity amid functional unblinding, operational barriers for early-stage companies, patient selection risks, off-label use concerns, and the impact of REMS and distribution controls.
Additionally, Ms. Chew offered insights on intellectual property strategies in this rapidly maturing field. Her commentary reflected deep engagement with regulators, sponsors, and stakeholders, emphasizing the importance of scientific rigor, ongoing advocacy, and proactive planning to ensure equitable access and commercial success for psychedelic therapies.