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The FDA Said No, What’s Next? Exploring the Field’s Next Chapter After the MDMA Decision

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Thursday, August 29th at 5 pm Pacific, 8 pm Eastern >> Log In To Watch the Recording >>

An EXCLUSIVE Panel Discussion For Members Of The Psychedelic Medicine Association:

The FDA Said No, What’s Next? Exploring the Field’s Next Chapter After the MDMA Decision

Host:

Lynn Marie Morski, MD, JD

Lynn Marie Morski, MD, JD

President, Psychedelic Medicine Association

Panelists:

Owen Muir, MD, DFAACAP

Owen Muir, MD, DFAACAP

Co-Founder, Fermata; Chief Medical Officer, iRxReminder

Owen Scott Muir, MD, DFAACAP is a dual board-certified child, adolescent and adult psychiatrist, and co-author of Adolescent Suicide and Self-Injury: Mentalizing Theory and Treatment. He has held academic appointments at Hofstra-Northwell, NYU and Baylor, and is the Chief Medical Officer for iRxReminder, which is the recent recipient of an SBIR Grant from the NIMH for their work in AI identification of tardive dyskinesia. He is also the Senior VP for strategy at Acacia Clinics and an advisor to Brainify.ai.

He has over 200 academic presentations and publications to his credit, focusing on high-risk populations and the role of interventional psychiatry. His main research interest is in neuromodulation for treatment resistant mood disorders and obsessive compulsive disorder. He has over 60,000 hours of clinical experience and is an official supervisor for the practice of Mentalization Based Treatment. Dr. Muir is a gifted educator who creates Continuing Medical Education materials for the American Academy of Child and Adolescent Psychiatry and writes for the general public on topics at the intersection of healthcare and society on his popular Frontier Psychiatrists Substack. When not working to champion help that is actually helpful, he enjoys creating music and watching esoteric documentaries, especially with his twin children. He is licensed in NY.

Carlene MacMillan, MD, FCTMSS, DFAACAP

Carlene MacMillan, MD, FCTMSS, DFAACAP

Co-Founder, Fermata; Chief Medical Officer, Osmind

Carlene MacMillan, MD, FCTMSS, DFAACAP is a dual board-certified child, adolescent and adult psychiatrist, and the Chief Medical Officer at Osmind, a platform that enables clinicians to deliver breakthrough mental health treatments. She completed her undergraduate and medical degrees at Havard and then went on to complete residency and fellowship at Harvard’s MGH/McLean Hospital. She is on the Board of Directors of the Clinical TMS Society and the Co-Chair of the CTMSS Insurance Committee. She is the Co-Chair of the American Academy of Child and Adolescent Psychiatry Consumer Issues Committee. Dr.MacMillan is on the board of the Ketamine Taskforce for Access to Safe Care and Insurance Coverage. She participates in real world evidence and post-marketing studies of transcranial magnetic stimulation and esketamine. She is extensively trained in Mentalization Based Treatment and applies it in individual, group therapy, family and team/systems settings.

As a psychiatric futurist, she speaks regularly at a wide range of conferences from the American Psychiatric Association to SXSW and to the media on a wide range of topics from psychedelic medicine to health tech innovations. Prior to Fermata, she was the inaugural Medical Director of the NYC Ellenhorn Private Assertive Community Treatment program and the founder of Brooklyn Minds, a groundbreaking high acuity outpatient mental health group practice which was acquired by Curated Mental Health in 2022. She is a mom to two amazing twins, one of whom also wants to be a “feelings doctor” who is “good at technology” when she grows up. She is licensed in NY, MA, NJ, CA, MS and TX.

Greg Jones, CRNA, MS, BSN

Greg Jones, CRNA, MS, BSN

Nurse Anesthetist, Co-Founder, & Clinic Director, Radiance Ketamine Clinic

Greg Jones is a board-certified registered nurse anesthetist (CRNA) by the National Board of Certification and Recertification for Nurse Anesthetists (NBCRNA). He also graduated from the University of Nevada, Reno with a second specialty as a Family Nurse Practitioner.

Prior to specializing in anesthesia, Greg worked as a pediatric nurse at Primary Children’s Medical Center and an emergency room nurse at Intermountain Medical Center in Salt Lake City, Utah. He also served as the clinical director of Maliheh Free Clinic, providing free medical services to those without insurance. While at the clinic, he saw the crippling effects that mental health disorders can have on people’s lives. His compassion for those suffering from these debilitating conditions grew as he heard their stories and saw their pain.

Greg was first introduced to ketamine over 10 years ago as an anesthesia student. He was amazed by its ability to help patients endure extremely painful procedures with minimal discomfort. As a result, he began regularly incorporating ketamine into his anesthetic practice and saw incredible results. The most impressive of which was for major spine surgery. He found that those that received ketamine during surgery woke up with less pain and required less medication during the post-operative period.

One day while working at the University of California San Francisco (UCSF), he went to interview his patient prior to surgery. During the conversation, the patient asked Greg if he would give him some ketamine while he was asleep. Surprised by this, he asked the man the purpose of his unique request. The patient said that he was a psychiatrist and had suffered from major depression since he was a young boy. He then mentioned that he had read several studies describing ketamine’s impressive anti-depressant effects. He was intrigued and wanted to see if ketamine would work for him. Greg obliged to the request and was excited to talk with the man when he woke up. To Greg’s delight, the man said that he felt remarkably better and was sure that it was a result of the ketamine. That night, Greg went home and began researching ketamine’s effect on depression and other mental health conditions. His fascination grew and eventually inspired him to co-found Radiance Ketamine Clinic in Reno, Nevada in 2020 and Vivid Life in Concord, CA in 2023. Greg is also the co-owner of Brain Health Restoration in Reno, Nevada. Greg finds great satisfaction in talking with his patients and hearing how ketamine has truly changed their lives.

When not at the clinic, Greg provides independent anesthesia services at a variety of medical offices in the greater Reno area. He also enjoys cooking, gardening, spending time outdoors, attending cultural events and singing in the Nevada Gay Men’s Chorus.

Reid Robison, MD, MBA

Chief Medical Officer at Novamind/Co-founder at Cedar Psychiatry

Dr. Reid Robison is a board-certified psychiatrist and Chief Medical Officer at Novamind. Reid is co-founder at Cedar Psychiatry and serves as Medical Director of Center for Change, a top Eating Disorder program. He is currently the coordinating investigator for the MAPS MDMA-assisted Psychotherapy study of Eating Disorders. Reid is adjunct faculty at the University of Utah, founder of the Polizzi Free Clinic, and provides medical support and psychedelic therapy at plant medicine retreats abroad.

In case you missed the news last week, the FDA officially denied Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy, requesting a new Phase III trial be conducted. 

This was a huge blow to the practitioners and patients who were hoping that MDMA would soon be a legal option to address PTSD, a condition where no other therapy has shown the same levels of efficacy as MDMA-assisted therapy.

So you may have questions, like, “When is the next psychedelic medicine likely to be up for FDA approval” and “Which medicine may be the next to reach that stage?” And you may also want an update on what psychedelics (like ketamine) are legally available and how might they serve as a stand-in for the others while we await FDA approvals.

This month we are truly fortunate to have panelists working in various arenas within psychedelic medicine and research to help lead a discussion regarding what psychedelic options are currently available and what’s to come, including:

  • Which psychedelic medicines are next in the FDA pipeline
  • When might we see another psychedelic therapy up for FDA approval
  • How can we utilize the available psychedelic options in the meantime

…and much more!

As always, there will be ample time for audience Q&A, so you’ll get to interact with the panelists directly!

So please join us for this live panel discussion on Thursday, August 29th at 5 pm Pacific, 8 pm Eastern. This is exclusively for members of the Psychedelic Medicine Association, so if you have not yet registered, please do so here. And for members, please register for the panel here. A link to the recording will be available afterward if you cannot make it to the live event.

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