Psychedelic drugs may offer promise for the treatment of certain mental health conditions, such as post-traumatic stress disorder (PTSD), but the development process is less straightforward than traditional medicines due to negative preconceptions and clinical study complexity. As psychedelics move from recreational use into clinical development, there is a need for greater clarity on the regulatory framework for these therapeutics. Psychedelic studies also present unique challenges related to protocol design, site selection, and study execution.
In this webinar, we explore the current landscape of psychedelic clinical development and discuss critical considerations for ensuring scientific rigor, patient safety, data quality, and ethical conduct.
Topics include:
- Review of the recent ADCOM meeting and FDA action letter for Lykos’ NDA for the use of MDMA as a treatment for PTSD
- Regulatory perspectives and guidance on clinical trials with psychedelic drugs
- Key considerations for designing and operationalizing psychedelic drug studies
- Approaches for selecting the right contract research organization (CRO) partner
Speakers:
Carlos Langezaal, Ph.D., Senior Director of Regulatory Affairs
Andreas Schreiner, M.D., Senior Vice President Medical Affairs, Neuroscience & Analgesia
