2024 Conference Agenda

Day Two - May 24, 2024

Continental Breakfast

Join us for breakfast and visit with our exhibitors

Chairperson's Opening Remarks

Peter Hendricks, Ph.D., Professor, Department of Psychiatry, University of Alabama Birmingham

Ibogaine and Noribogaine: Opening a Window of Neuroplasticity in Addictive Disorders

Ibogaine is a psychedelic indole alkaloid that has shown benefit in the treatment of substance use disorders. Noribogaine was identified in 1995 as an active metabolite of ibogaine. The potential therapeutic utility of ibogaine for substance use disorders and persistence of beneficial effects are thought to be mediated in part by noribogaine. Noribogaine is capable of promoting structural neural plasticity, a mechanism that is shared by serotonergic psychedelics and ketamine. The lecture will critically review ibogaine as a method of use therapy for substance use disorders. Noribogaine will be discussed in the broader context of psychedelic microdosing strategies which avoid the subjective effects which may not be therapeutic.

Deborah Mash, Ph.D., Chief Executive Officer & Founder, DemeRx

A Simple Blood Biomarker’s Potential to Measure Therapeutic Response in Psychedelics

In this presentation, Dr. Rasenick will discuss research that reveals the potential for a simple blood biomarker for depression. Data to date suggests its utility in measuring the antidepressant potential of psychedelics and its application in clinical trails and antidepressant drug development.

Mark Rasenick, Ph.D., Distinguished Professor of Physiology & Biophysics & Psychiatry, University of Illinois College of Medicine, Chief Scientific Officer, Pax Neuroscience

Development of "Trifunctional" Gq-Biased 5-HT2C Receptor Agonists

The 5-HT2C receptor is a validated therapeutic drug target for a variety of diseases and disorders, including schizophrenia, epilepsy, obesity, and nicotine, alcohol and psychostimulant abuse. However, previous attempts to design selective 5-HT2C receptor ligands have been plagued by undesirable off-target effects, including aberrant activation of 5-HT2A (hallucinations) and 5-HT2B (valvulopathy). Recent studies have also suggested that agonist-induced signaling via beta-arrestin at 5-HT2C can result in receptor internalization and signal desensitization, resulting in therapeutic tolerance in the long term. Thus, functionally selective 5-HT2C receptor agonists that are antagonistic at 5-HT2A and 5-HT2B represent attractive targets for the development of a variety of antipsychotic and anti-addiction therapeutics.

Jeremy Forest, Co-Founder & Chief Operating Officer, Kuleon Biosciences

Next-Generation Entheogens: Probing Underexplored Psychedelic Botanicals & Synthetic Derivatives

There is a wide variety of plants and fungi with long ethnobotanical histories that have been overlooked and understudied by Western science. This presentation will describe how Entheos Labs, in collaboration with members of the Mass General Hospital’s Center for the Neuroscience of Psychedelics, is leveraging its own internal platforms to discover novel, non-scheduled psychedelics. Scalable, high-throughput and functional neuroplasticity assays in human IPSCs will produce multi-dimensional data enabling a signature-based strategy to identify next-generation therapeutics.

Darrick Balu, Ph.D., Chief Scientific Officer, Entheos Labs

Morning Break

Join us for morning coffee and tea, visit with our exhibitors and our Scientific Poster presenters

Panel Session: Reimagining the Framework for Psychedelic Research and Access: Progress and Barriers

In this session our panelists will share the work they are doing to increase access to psychedelics via rescheduling efforts and advocacy. They will discuss the means by which organizations can navigate Schedule I clinical research regulations. Lastly, they will offer their perspectives on the work that still needs to be done to develop the regulatory infrastructure for research and safe access to psychedelic therapies.

Brett Waters, JD, Founder & Executive Director, Reason for Hope

Anthony Coulson, President, NTH Consulting

Mark Rasenick, Ph.D., Distinguished Professor of Physiology & Biophysics and Psychiatry, University of Illinois College of Medicine, Chief Scientific Officer, Pax Neuroscience

Brett Waters, JD
Brett Waters, JD
Anthony Coulson
Anthony Coulson
Mark Rasenick, Ph.D.
Mark Rasenick, Ph.D.

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, Patent Attorney, Calyx Law

Fusing AI-models of Biometrics and Psychometrics to boost Psychedelic Drug Approvals

Sama Therapeutics' cutting-edge AI platform is fusing and cross-validating biometric and psychometric data to identify novel digital biomarkers and endpoints for psychedelic drug development. We will use a series of data-driven case studies to demonstrate how leveraging these predictive models can reduce confounds like placebo functional unblinding and dose-dependent variation, and advance monitoring in real-time with state-based biomarkers for each patient's unique neurobiological and psychological profile.

Shobi Ahmed, MD, Ph.D., Chief Executive Officer, Sama Therapeutics

From Start-Ups to the Chemistry and Biology of Psychedelic Inspired Medicines – From the Extracellular Matrix to Inside the Cell.

In this lecture I will speak about some of my experiences in working with start-up companies as well as the science that is involved. My interest in the serotonin field started with creating novel 5-HT2C selective compounds to treat schizophrenia, a goal we achieved while I was working as a Professor at the UIC. The 5-HT2C patent resulting from the university work was licensed to a start-up, and the lead drug candidate BMB-101 was advanced for Dravet syndrome. From there I went on to design a host of novel 5-HT2A agonists that are the subject of multiple patent filings, with some of the more interesting NCEs being invented at Negev Labs and PurMinds NeuroPharma. However, in all this work, because of the link between activation of the 2A receptor and downstream signaling, I have always been fascinated by the possibility of the role of the epigenome in subsequent biological events. In particular, the inhibition of certain histone deacetylases appears able to recapitulate some of the ultimate actions of 5-HT2A agonists in treating human diseases. I will provide some thoughts on these various topics in my lecture.

Alan Kozikowski, Ph.D., Chief Scientific Officer, PurMinds NeuroPharma


Optimizing Real-World Benefits and Risks of New Psychedelic Medications: The Need for Innovative Postmarket Surveillance

As pharmaceutical psychedelics near the end of the drug development pipeline, attention will begin to shift from FDA approval to potential post-market requirements for monitoring and risk mitigation. In this presentation, we will outline the components of one post-market framework and note limitations in current monitoring system capabilities. Pilot data from two novel data sources will be included in the presentation.

Jennifer Jewell, DrPH, Assistant Research Scientist, Rocky Mountain Poison & Drug Safety

The Current State of Psychedelic Neuroimaging: Findings, Limitations, and Paths Forward

The application of the tools of modern human neuroimaging – using modalities such as functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and magnetoencephalography (MEG) – to psychedelics has offered an unprecedented window into the functional brain changes underlying the acute psychedelic experience. In this talk, I’ll provide a critical overview of current state of knowledge in the exciting fledgling field of psychedelic neuroimaging – highlighting core findings, limitations, contentions, and possible paths forward. I’ll also situate psychedelic neuroimaging in the context of broader research on the neurobiological mechanisms of psychedelic drug effects. Overall, I seek to highlight the value of, and potential for, a multi-scale, translational conception of psychedelic brain action.

Manesh Girn, Ph.D., Postdoctoral Neuroscientist, Carhart-Harris Lab, UC San Francisco

Exploration of Safety, Tolerability and Pharmacodynamics of a Novel Oral NMDA Antagonist Across a Range of Exposure in Healthy Volunteers

Dr. Christian will present results of Phase 1 single and multiple dose studies of the Gilgamesh proprietary oral NMDA antagonist, GM-1020, in healthy volunteers. Results have identified a hypothetical clinical dose range where resting EEG and subjective pharmacodynamic scales establish increasing target engagement. Over this dose range, however, minimal dissociative and sedative adverse events were observed, which are well known to be significant and undesirable adverse effects that necessitate clinical supervision during subanesthetic ketamine / esketamine dosing to treat major depression. In this presentation, Dr. Christian will discuss details of the Phase 1 safety, PK and PD results in which they established good dose-proportional PK with high oral bioavailability, and PD effects supporting a range of target engagement across the study regimen.

Ed Christian, Ph.D., Executive Director Clinical Science, Gilgamesh Pharmaceuticals

Where is the Science of Psychedelics Taking Us? New Directions and Detours

Chair: Peter Hendricks, Ph.D., Professor, Department of Psychiatry, University of Alabama Birmingham

Charles Nichols, Ph.D., Professor, LSU Health Sciences Center

Bernard Lerer, MD, Professor of Psychiatry, Director, Hadassah BrainLabs - Center for Psychedelic Research, Hebrew University

Alan Kozikowski, Ph.D., Chief Scientific Officer, PurMinds NeuroPharma

Deborah Mash, Ph.D., Chief Executive Officer & Founder, DemeRx

Peter Hendricks, PhD.
Peter Hendricks, PhD.
Charles Nichols, Ph.D.
Charles Nichols, Ph.D.
Bernard Lerer, MD
Bernard Lerer, MD
Alan Kozikowski, Ph.D.
Alan Kozikowski, Ph.D.
Deborah Mash, Ph.D.
Deborah Mash, Ph.D.

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