2023 Conference Agenda

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

Day One - May 15, 2023

7:50 am

Chairperson's Opening Remarks

8:00 am

Responsible Business in the Psychedelics Industry; the Good, the Bad and the Ugly?

While clinical evidence is beginning to show the potential and promise for psychedelics as a public health good, the industry lives somewhat in the shadows of Bad Pharma and a tarred history dating back to the 1960s. Drawing on existing research, theoretical standpoints on corporate social responsibility and parts of a secondary analysis of biotech microdosing companies’ websites this talk explores what responsible business may look like for the psychedelic industry. The talk will also include the challenges lying ahead as conversations around legislative changes progress. Key themes that will be covered include the compounds quality, accessibility to the treatment, the management of commercial interests, the sustainability and environmental impact of infrastructure, and inclusivity and diversity across those working in the industry.
Charlotte Smith, Ph.D., Associate Professor in Management and Organisation, University of Leicester

8:25 am

A Complex Systems Perspective on Large-Scale Psychedelic Brain Action

In this talk, I’ll first offer a brief overview of psychedelic neuroimaging findings, with an emphasis on inconsistencies and limitations of past work. I will then draw from emerging perspectives on brain function derived from complexity science to offer a conception of psychedelic large-scale brain action that can render these inconsistencies intelligible. This perspective foregrounds the distributed, interactional, and dynamic nature of neural processing, and proposes that psychedelics can be better thought of as inducing a distinct dynamical mode of brain function. This mode of brain function is more dynamically flexible and diverse, sensitive to perturbations, and tuned for information sharing – consistent, in complex systems language, with greater criticality and metastability. I highlight how this conception of psychedelic action can help unify past findings and provide intuitive explanations for core components of psychedelic subjective effects, as well as how it aligns with micro/meso-scale neurobiological mechanisms.
Manesh Girn, Ph.D Candidate (Neuroscience), Laboratory of Brain and Cognition, Montreal Neurological Institute, McGill University

8:50 am

Psychedelics & Drug Interaction

This talk will discuss known drug interactions with commonly used psychedelics including psilocybin, LSD, and ayahuasca. Using a variety of data sources, it will discuss interactions with antidepressants, antipsychotics, and mood stabilizers as well as theoretical risks and lack thereof.
Sandeep Nayak, MD, Assistant Professor, Department of Psychiatry & Behavioral Sciences, Behavioral Pharmacology Research Unit, Johns Hopkins Center for Psychedelic & Consciousness Research
9:15 am

Entourage Power: Studies on Full Spectrum Mushroom Extract and Chemical Psilocybin

In psychedelic mushrooms, the key psychoactive component, psilocybin, is produced along with several entourage molecules including tryptamines and harmines with monoamine oxidase inhibiting properties. The role of these entourage molecules in the psychoactive effect of psychedelic mushrooms is not fully understood. Anecdotal reports suggest they may be additive. We have studied the effects of full spectrum mushroom extract (produced by Parow Entheobiosciences) in comparison to chemical psilocybin (supplied by Usona) at equivalent psilocybin doses in mouse models of psychedelic drug action and on measures of synaptic plasticity. Findings from a comparison of these effects will be presented and discussed.
Bernard Lerer, MD, Professor of Psychiatry , Center for Psychedelic Research, Hadassah Medical Center, Hebrew University, Director, Hadassah Brain Labs
9:40 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.

10:05 am

Disruptive Trial Design to Meet the Psychedelic Challenge: from Active Placebos to Anesthesia

Randomized, placebo controlled clinical trials are intended to isolate drug specific therapeutic effects. This classical style of study has always been limited when applied to psychoactive drugs and psychotherapy, but never moreso than with psychedelic therapeutics. In this session, the panelists will make the case that, rather than abandon structured trials altogether, a suite of highly creative and innovative methods can help medical scientists adapt to the challenge of understanding psychedelics.
Joshua Woolley, MD, Ph.D., Associate Professor, Psychiatry, UCSF Weill Institute for Neurosciences
Boris Heifets, MD, Ph.D., Assistant Professor of Anesthesiology, Perioperative & Pain Medicine, Stanford University

10:40 am

Reopening Critical Periods with Psychedelics: Basic Mechanisms and Therapeutic Opportunities

During specific periods of brain development, the nervous system exhibits heightened sensitivity to ethologically relevant stimuli, as well as increased malleability for synaptic, circuit, and behavioral modifications. These mechanistically constrained windows of time are called critical periods and neuroscientists have long sought methods to reopen them for therapeutic benefit. Dr. Dolen will present evidence that the ability to reopen critical periods is a common neurobiological mechanism that can account for shared therapeutic effects of psychedelics. These results have significant implications for the implementation of psychedelics in clinical practice, as well as the design of novel compounds for the treatment of neuropsychiatric disease.
Gul Dolen, MD, Ph.D., Associate Professor of Neuroscience, Brain Institute, Wendy Klag Center, Johns Hopkins University

11:05 am

PANEL SESSION: Overcoming the Complexities of Psychedelic Trials

Clinical trials on psychedelic compounds are not as easy to run as traditional pharmaceutical trials. They present unique challenges and many unanswered questions. In this session our panelists will discuss the followiing points:
  • The main barriers to clinical trials and how to overcome them. (Eg. challenges of getting Schedule 1 licenses, lack of expertise in psychedelic trial design, managing groupthink, participant recruitment, inclusion/exclusion criteria, finding and training therapists, ensuring consistency of therapy, and getting the 'setting' right.)
  • The utility (or lack thereof) of pre-clinical testing with psychedelic compounds
  • How the FDA, MHRA & EMA differ in approach to these treatments
  • What's next for trials in this space
Tom McDonald, Chief Executive Officer & Co-Founder, Clerkenwell Health
Clare Knight, Senior Clinical Trials Manager, Clerkenwell Health
James Lanthier, Chief Executive Officer & Co-Founder, Mindset Pharma
Harpreet Kaur, Ph.D., Vice President of Research, PharmAla Biotech

11:45 am

Addressing Blinding Integrity and Expectancy Bias in Psychedelic Trials

Psychedelic clinical trials have inherent challenges related to functional unblinding of treatment groups and expectancy bias from both participants and study personnel; however, these issues are not new in psychiatry. Should blinding integrity and expectancy bias be measured and if so, how? Proposed methods will be discussed along with strategies to reduce bias and functional unblinding through protocol design, selection of participants, and operational study execution.
Christine Moore, Ph.D., VP Neuroscience, Scienfitic Solutions, Worldwide Clinical Trials
12:10 pm

Luncheon

We have numerous options for your lunch experience. Join colleagues in our dedicated lunch space, eat in the restaurant, eat outside on the restaurant patio, or take a box lunch and retire to your guest room for some quiet time.

1:05 pm

The Ketamine Endgame

Recently, a New York Times headline described ketamine as a "cure," a word not often used for medical therapies. Lots of people with treatment-resistant depression, anxiety and pain will surely be impacted by ketamine. If indeed we are looking at a cure, how will it reach patients--and which companies will profit from it? The FDA (the "gatekeeper") will play a pivotal role. And, there is precedent for how they will likely act. Spoiler alert, there will be losers and an exceedingly few winners among the companies vying to capitalize on this cure. I'm predicting one or more billion dollar fortunes will be made.
James Kuo, MD, MBA, Vice President of R&D, Silo Pharma

1:30 pm

Better Than Ecstasy: Progress in Developing a Novel Class of Therapeutic /span>

MDMA has an apparently novel therapeutic mechanism that is distinct from classical psychedelics and that may offer benefits in a wide range of CNS disorders. This presentation will describe the history of attempts to develop novel compounds that improve on MDMA, summarizing both the scientific and IP landscapes.
Mathew Baggott, Ph.D., Co-Founder & CEO Tactogen

1:55 pm

Presentation to be Announced

2:20 pm

Presentation to be Announced

2:45 pm

Afternoon 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.

3:10 pm

Panel Session to be Announced

3:50 pm

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
4:15 pm

Presentation to be Announced

Laszlo Kiss, Ph.D., CBO & Head of Research, Gilgamesh Pharmaceuticals

4:40 pm

Reception: Hors d'oeuvres & Drinks

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