The afternoon session of Day 3 began with this top-quality panel. An overview of the current psychedelic innovation landscape, examining the potential for implementing psychedelic treatments in mainstream healthcare, and the challenges faced by companies in bringing them to market.
The panel included:
Shayla Love: a science journalist and senior staff writer at VICE News on the features desk. She has written extensively about psychedelic research and culture.
Gregg Peterson: CEO & co-founder of Bexson Biomedical, a firm developing subcutaneous formulation technology and a wearable device for several psychedelic compounds.
Winston de la Haye: Senior Lecturer in Psychiatry at The University of the West Indies (UWI), Jamaica. Consultant Addiction and General Psychiatrist at the University Hospital.
Courtney Barnes: A devoted social justice attorney and leading trailblazer in drug policy reform. Ms. Barnes serves as Policy Advisor for Decriminalize Nature, General Counsel for SPORE, and Advisory Board Member of Heroic Hearts Project.
Angus Taylor: CEO Med Plant Science, a biotechnology company focused on developing advanced medications for the treatment of mental health conditions using active ingredients from psychedelic plants and fungi.
Itamar Grotto: Executive Chairman, PsyRx. Public Health Physician and Professor of Epidemiology, former Member of the Executive Board of the World Health Organization (WHO).
Some quotes and highlights from the panel:
Courtney Barnes: “Because of the Schedule 1 classification of these substances, it is very hard to engage in research, especially research that will be recognized by the FDA. And in order to engage in research in the United States with a scheduled compound, you must have a DEA authorization and the DEA has historically limited who is able to receive them. And rescheduling psychedelics is tricky.”
The DEA also limits the number of applications per year for researchers around Schedule 1 compounds.
“There are definitely quotas in alignment with the international treaties. But the DEA did just recently exponentially increase the quotas for manufacturing, but it is very tightly controlled and it’s limited. You can’t just get a DEA authorization and produce as much psilocybin as you’d like.”
A big barrier to actual integration into our healthcare models.
The panel then went on to discuss the lessons from cannabis, with Dr. Itamar Grotto recounting some of the barriers due to stigmatization and the importance of having solid research backing trials and work with regulatory agencies.
Shaila Love, the panel moderator: “Maybe you can share some perspectives on developing companies around products that are not legal yet not just not FDA approved, but Schedule 1. What are some of the obstacles or logistical challenges you face that might dissipate with either escheduling or better integration into healthcare systems?
Gregg Peterson: “There’s definitely some reduction in access. We’ve been able to get Schedule 1 drugs, in some cases we just hired a manufacturing lab that does have a DEA license to make it for us. It wasn’t cheap and easy. And it would be cheaper and easier if you change the classification to Schedule 2 or Schedule 3. It will make it easier and cheaper to do these studies. The logistics are a big thing. Does your shipper have a Schedule 1 license? The clinicians that are in your clinical trial, does he or she have a Schedule 1 license? Are they willing to put it under double lock and key in their office? There’s a cost to that and restriction to access.”
The discussion continued on, covering topics around access, future insurance coverage, reducing costs to increase access, and other changes that will help integration into existing medical models (i.e: reducing time of therapy sessions)
The panel was informative and showed that those involved in the future of the space are learning from past lessons and working on best ways forward.
