2023 Conference Agenda
Day Two - May 16, 2023
Chairperson's Opening Remarks
Mark Johnston, MD, FRCPC, Director CNS Research/Medical Director, Atlantic, Centricity Research
The Natural Advantage: A Novel Approach to Approval
Benjamin Lightburn, CEO & Co-Founder, Filament Health
Psilocybin-assisted Therapy for Eating Disorders: Clinical Considerations and Preliminary Observations from a Pilot Study
This talk will 1) provide a brief overview of research to date on psychedelic-assisted therapy for eating disorders, 2) cover clinical considerations for the use of psychedelics in patients with anorexia and other eating disorders, and 3) review preliminary findings from on ongoing pilot study in patients with anorexia nervosa.
Natalie Gukasyan, MD, Assistant Prof., Dept. of Psychiatry & Behavioral Sciences, Medical Dir., Center for Psychedelic & Consciousness Research, Johns Hopkins University School of Medicine
New Insights into the Molecular Details of Psychedelic Drug Actions
Ryan Gumpper, Ph.D., Postdoctoral Research Associate and Project Manager of DARPA Focused Pharma Initiative, University of North Carolina Chapel Hill
Investigator-Sponsored Research: Considerations for Researchers and Drug Companies
Hailey Gilmore, MPH, Medical Affairs Program Manager, MAPS Public Benefit Corporation
Visit the scientific poster session, network with colleagues over coffee and snacks, visit with our exhibitors and meet new people via our meeting scheduling solution.
PANEL SESSION: Psychedelics & Clinical Trials: Site Feasibility and Audit Preparedness
FDA-approved clinical trials are critically important for psychedelics to becoming accepted and recognized as substances with approved medical use. Psychedelics such as MDMA and psilocybin are approaching federal regulatory approval for use to treat depression, anxiety, and a variety of substance use disorders. Many innovators and scientists are interested in running clinical trials in order to prove safety and efficacy and as a necessary step to eventual commercialization. The speakers will provide an overview of current psychedelic clinical trials for certain mental health and behavioral health treatments, outline some of the requirements for clinical site feasibility, licensing requirements that sponsors will need to bear in mind when choosing a clinical trial site, the challenges of running and operating clinical trials for Schedule I drugs, and areas of concern in order to be prepared for a clinical site audit.
CHAIR: Sabrina Ramkellawan, CCRP, CCRA, Chief Operating Officer & Co-Founder, AxialBridge (formerly known as Knowde Group)
Karen Luong, JD, Senior Counsel, Husch Blackwell
Kimberly Chew, JD, Senior Counsel, Husch Blackwell
Natasha Sumner, JD, Senior Counsel, Husch Blackwell
The Future of Psychedelic Funding: Building a Bridge to Mainstream Biotech
The capital needs for drug development are vast, and the psychedelic industry is no exception. While a core of early-psychedelic VCs has emerged, the aggregate capital of these funds will be insufficient to advance the current plethora of psychedelic molecules through the clinic. This nascent sector will therefore need to expand the tent and collaborate with the traditional life sciences investing universe to give these medicines the hope of receiving ample downstream funding. With this said, the lens that the traditional biotech universe views opportunities through is very different from the psychedelic sector, and often the diligence burden is far higher. Tim Schlidt’s presentation will cover the impact the current macro environment will have on investment into psychedelic companies and then shift to a focus on Palo Santo’s diligence process and how the fund vets opportunities through a lens that is palatable to more traditional life sciences funds. Furthermore, Tim will cover the major factors that traditional investors are looking to derisk, and how psychedelic companies can preempt these.
Tim Schlidt, Co-Founder & Partner, Palo Santo
PANEL SESSION: Rescheduling Psychedelic Drugs: Developments, Opportunities, and their Implications for Advancing Scientific and Medical Use
CHAIR: Karen Luong, Senior Counsel, Husch Blackwell
Brett Waters, Co-Founder & Executive Director, Reason for Hope, Associate Attorney, Winston & Strawn
Matthew Zorn, Partner, Yetter Coleman
Group Sessions Can Make Psychedelic Treatment More Accessible: Empirical Evidence
Elliot Marseille, DrPH, MPP, Director, UC Berkeley/UCSF Global Initiative for Psychedelic Science Economics, Principal, Health Strategies International
The Cost-effectiveness of Psilocybin-assisted Therapy for Major Depressive Disorder: Exploratory Results
Anton Avanceña, Ph.D., Assistant Professor of Health Outcomes, University of Texas at Austin College of Pharmacy
Psychedelic Patents - Avoiding Controversy While Achieving Defensible and Enforceable IP
Most will agree that patents are necessary for drug development, because without the reward of exclusivity, the investment in trials can be impossible to justify, and new drugs may never reach the market. But how can strong IP be built around known psychedelic compounds, or even variations of them, especially in a crowded field with many close competitors, with significant uncertainties around REMS—and in view of controversies around whether patents should be granted on psychedelics at all? How can a patent strategy be best designed to account for these difficulties, while taking advantage of regulatory exclusivities and other incentive mechanisms to bring innovative therapeutics into the clinic and to patients?
Graham Pechenik, JD, Founder, Patent Attorney Calyx Law