2023 Conference Agenda

(The agenda for this event is still being updated. Please check back in coming days for additional details)

Day Two - May 16, 2023

8:30 am

Chairperson's Opening Remarks

8:35 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

9:00 am

New Insights into the Molecular Details of Psychedelic Drug Actions

Bryan Roth, MD, Ph.D., Michael Hooker Distinguished Prof., Pharmacology, Director, NIMH Psychoactive Drug Screening Program, Eshelman School of Pharmacy, University of North Carolina Chapel Hill

9:25 am

Panel Session to be Announced

10:05 am

Update on Development of MDMA-AT for PTSD and Pipeline Programs

MAPS PBC recently completed a second Phase 3 study (MAPP2) to evaluate the use of 3,4-methylenedioxy-methamphetamine (MDMA)-assisted therapy (MDMA-AT) for treatment of posttraumatic stress disorder (PTSD) and strengthen existing safety and efficacy evidence from the initial Phase 3 study (MAPP1). To further support a New Drug Application to the US Food and Drug Administration, pharmacokinetic data, as well as long-term follow-up data, are needed to enhance understanding of drug metabolism, safe administration, and the durability effect of MDMA. Implementing MDMA-AT in the American healthcare system may require innovations in scalability and delivery. Given the prevalence of PTSD in veterans, adaptation for use in Veterans Affairs may require considerations such as tailoring the number of medication sessions to an individual’s disease severity, ensuring an adequate number of therapists are trained in MDMA-AT and have personal experience with MDMA, and exploring cost-effective treatment and integration models such as group therapy. In addition to PTSD, preliminary data from several pilot trials suggest safety and effectiveness of MDMA-AT to treat other psychological disorders. During the session, enrollment data and other indicators from the MAPS PBC pivotal phase 3 program and an overview of the pipeline and Investigator-Initiated Trials programs will be presented.
Hailey Gilmore, MPH, Medical Affairs Program Manager , MAPS Public Benefit Corporation
10:30 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.

10:55 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.
Jaspreet Grewal, Chief Executive Officer & Co-Founder, Knowde Group
Sabrina Ramkellawan, CCRP, CCRA, Chief Operating Officer & Co-Founder, Knowde Group
Karen Luong, JD, Senior Counsel, Husch Blackwell
Kimberly Chew, JD, Senior Counsel, Husch Blackwell
Natasha Sumner, JD, Senior Counsel, Husch Blackwell

11:35 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

12:00 pm

Luncheon

 

12:55 pm

PANEL SESSION: (tentative title) Changing the Game: Ongoing Efforts to Reschedule Psilocybin

Christopher Koddermann, Co-Founder & Chair of the Board, International Therapeutics Psilocybin Rescheduling Initiative
Brett Waters, Co-Founder & Executive Director, Reason for Hope, Associate Attorney, Winston & Strawn
Matthew Zorn, Partner, Yetter Coleman

1:35 pm

The Cost and Cost-effectiveness of MDMA-assisted Therapy for PTSD: Extended Sensitivity and Scenario Analyses

The economics of MDMA-AT will vary according to the ‘real-world’ values of a range of important variables many of which remain uncertain. We therefore constructed a set of cost and cost-effectiveness scenarios that capture the most likely results in different settings and under different assumptions about the correct value of key inputs. Our methods and results are presented here.
Elliot Marseille, DrPH, MPP, Director, UC Berkeley/UCSF Global Initiative for Psychedelic Science Economics, Principal, Health Strategies International
2:00 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

2:25 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

2:50 pm

Presentation to be Announced

3:15 pm

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