Join Dr. Scott Shannon (MAPS principal investigator on its Phase 3 MDMA Clinical Trial), and ATMA CEO, Vu Tran to learn more about In-Person MDMA-Assisted Therapy Training, based on MAPS protocols, coming to Calgary in May 2024 as well as ATMA-CENA plans for expanding clinic infrastructure in Canada. With priority review in the US by the FDA and the expected priority review in Canada initiated by Lykos, there is an urgency for both training and clinics to be ready for legalization. The FDA recently granted Lykos Therapeutics (formerly MAPS PBC) a priority review on their New Drug Application (NDA) for MDMA, allowing for a shorter review period of 6 months vs the 10 months conventional review period. The FDA could grant Lykos MDMA approval for therapy as early as August 2024. The rescheduling MDMA could be another 3 months from FDA approval but it’s likely MDMA-assisted therapy (MaT) will be available to some individuals before the end of 2024. Training and clinic infrastructure to provide MDMA-assisted therapy is quickly becoming the priority to focus on to make this treatment accessible in both the US and Canada.
The expectation is that Lykos will take a similar path of requesting a priority review to Health Canada for a New Drug Submission (NDS) upon approval from the FDA. Although legalization for MaT in Canada will be behind the US, we could likely see Health Canada approval early to mid 2025.
Join Reverdi Darda, MAPS Canada Board member, in discussion with Dr. Shannon and Vu Tran as we discuss these exciting and rapidly-unfolding developments in psychedelic assisted therapy in Canada.
Learning Objectives:
Dr. Scott Shannon: Scott has been a student of consciousness since his honor’s thesis on that topic at the University of Arizona in the 1970s. Following medical school, MDMA assisted psychotherapy became a facet of his practice before this medicine was scheduled in 1985. He then completed a psychiatry residency at a Columbia program in New York. Scott studied cross-cultural psychiatry and completed a child/adolescent psychiatry fellowship at the University of New Mexico. Scott has published four books on holistic and integrative mental health including the first textbook for this field in 2001. He founded Wholeness Center, the largest integrative mental health center in the US, in 2010 with a group of aligned professionals to create innovation in collaborative mental health care.
Scott is a past president of two national medical organizations. He serves as a site Principal Investigator and therapist for the Phase III trial of MDMA assisted psychotherapy for PTSD and for the Phase IIB trial of LSD for generalized anxiety disorder. He has also published numerous articles about his research on cannabidiol (CBD) in mental health. Scott co-founded the Psychedelic Research and Training Institute (PRATI) to train professionals in ketamine-assisted psychotherapy and deliver clinically relevant studies. Scott helped to initiate the Board of Psychedelic Medicine and Therapies in 2021. He lectures all over the world to professional groups interested in a paradigm shifting perspective about transformative care.
Vu Tran: Vu is a student of plant medicine, has his yoga instructor certification and also 20 years of experience as a strategic investor and successful entrepreneur. He believes in pursuing a balanced life of business ambition with life giving work, that which nourishes the human spirit.
Vu is a life long entrepreneur and has founded, scaled and exited multiple ventures in a variety of markets including real estate, land development, hospitality, entertainment, retail and cannabis. Whether owned, led or partnered with, he has created a combined enterprise value of over $60M from all his ventures to date. As a result of his own experience and work, Vu is deeply involved with and passionate about what psychedelic medicine can bring to Canadians suffering with mental health issues.
