2023 Conference Agenda

Day Two - May 16, 2023

7:45 am

Continental Breakfast

8:30 am

Chairperson's Opening Remarks

Mark Johnston, MD, FRCPC, Director CNS Research/Medical Director, Atlantic, Centricity Research

8:35 am

The Natural Advantage: A Novel Approach to Approval

In this presentation Ben will speak about how natural extraction could be the best way to access the untapped drug discovery potential of hundreds of psychedelic species. Rather than synthesizing new molecules, Filament develops the technology necessary to create pharmaceutical-grade drug candidates of naturally-occurring compounds. This has allowed the company to enter botanical psychedelic drug candidates into FDA clinical trials for the first time, including a trial featuring the first-ever direct administration of psilocin. Ben will expand upon the approval pathway for natural psychedelics as well as his team's clinical studies that feature both novel trial design and a novel compound.
Benjamin Lightburn, CEO & Co-Founder, Filament Health

9:05 am

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

9:35 am

New Insights into the Molecular Details of Psychedelic Drug Actions

With renewed interest in psychedelic compounds as a clinical tool for many intractable mental health ailments, the basic science behind their molecular interactions with the 5HT2A receptor as well as overall pharmacology has remained relatively unexplored. This talk aims at beginning to elucidate the molecular interactions between many of the classical psychedelic compounds and the 5HT2A receptor and how this informs their complex pharmacology.
Ryan Gumpper, Ph.D., Postdoctoral Research Associate and Project Manager of DARPA Focused Pharma Initiative, University of North Carolina Chapel Hill

10:05 am

Investigator-Sponsored Research: Considerations for Researchers and Drug Companies

As trials and companies proliferate in the psychedelic sector, more investigator-sponsored research (ISR) will continue to emerge to fill knowledge gaps the pharmaceutical drug development path may not directly address. The aim of this talk is to identify resources and guidelines, and share best practices using a strategy-value framework, for both prospective researchers and companies seeking to build an ISR program, leveraging observations and lessons learned from the largest and most-established ISR program in the space.
Hailey Gilmore, MPH, Medical Affairs Program Manager, MAPS Public Benefit Corporation

10:35 am

Morning Break

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.

11:00 am

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

11:45 am

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

12:15 pm

Luncheon

1:10 pm

PANEL SESSION: Rescheduling Psychedelic Drugs: Developments, Opportunities, and their Implications for Advancing Scientific and Medical Use

Following the decision of the Australia to reschedule MDMA and psilocybin on a limited basis to allow for their medical use in treating PTSD and depression, rescheduling efforts have come into focus as a promising opportunity to expedite research and expand patient access. In this session, our panelists will discuss ongoing initiatives both in the U.S and internationally to reschedule various psychedelic drugs and what the success of these efforts may mean for the future of psychedelic research and medicine.
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

1:55 pm

Group Sessions Can Make Psychedelic Treatment More Accessible: Empirical Evidence

At current costs, many people who could benefit from psychedelic therapy will not be able to afford or access it. Eventual adoption by insurers may increase access, but will depend on demonstrating cost-effectiveness. One strategy to lower costs is to incorporate group sessions into the treatment regimen. We compared the costs of group and individual psilocybin therapy for end of life distress and for MDMA therapy for PTSD using empirical cost data. We also examined the effect of MDMA and psilocybin prices on overall costs and the relative savings from group therapy. We present the implications for cost savings, access and the effective supply of trained therapists.
Elliot Marseille, DrPH, MPP, Director, UC Berkeley/UCSF Global Initiative for Psychedelic Science Economics, Principal, Health Strategies International

2:25 pm

The Cost-effectiveness of Psilocybin-assisted Therapy for Major Depressive Disorder: Exploratory Results

Adoption of psychedelic-assisted therapies will depend, in part, on their economic value. In this presentation, we share a preliminary analysis of the long-term cost-effectiveness of psilocybin-assisted therapy for treating major depressive disorder. Our individual-level model uses efficacy results from various clinical trials and identifies key drivers of the economic value of psilocybin-assisted therapy compared to current standard of care.
Anton Avanceña, Ph.D., Assistant Professor of Health Outcomes, University of Texas at Austin College of Pharmacy

2:55 pm

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

3:25 pm