MAPS’ Drug Development Strategy: MDMA-Assisted Psychotherapy for PTSD

Amy Emerson

 

 

Abstract: This talk will describe MAPS' overall clinical development strategy for navigating the regulatory requirements for developing MDMA-assisted psychotherapy into an FDA-approved prescription treatment for people suffering from PTSD. We will review the steps and milestones associated with the three-year timeline for Phase 2 and the FDA End-of-Phase 2 meeting, and the additional five-year timeline for Phase 3. The presentation will outline new FDA programs that may be helpful in expediting the process, including Fast Track, Special Protocol Assessment, Breakthrough Drug Designation, and Expanded Access. This general strategy also applies to other psychedelic drug development programs.

Amy Emerson earned her BS in genetics and cell biology from Washington State University. She has worked in clinical development and research for the last 15 years in the fields of immunology (Applied Immune Sciences), oncology (RPR), and most recently in vaccine development (Chiron and Novartis). Amy has worked with MAPS as a volunteer since 2003 facilitating the development of the MDMA clinical program. She is currently working as Director of Clinical Research and is involved with creating the structure needed to support the growing needs of the clinical operations group and MAPS clinical research studies.

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