2023 Conference Agenda

Day One - May 15, 2023

7:15 am

Registration & Continental Breakfast

8:00 am

Chairperson's Opening Remarks

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

8:10 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

8:40 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
9:10 am

Psychedelics Promote Neuroplasticity Through the Activation of intracellular 5-HT2A Receptors

Psychedelic compounds promote cortical structural and functional neuroplasticity through the activation of serotonin 2A receptors. This talk will present evidence that activation of intracellular serotonin 2A receptors are responsible for the plasticity-promoting and antidepressant-like properties of psychedelic compounds. These results further elucidate the mechanism of action of psychedelics and suggest a possible role for endogenously produced N-methyltryptamines.
Max Vargas, Ph.D. Candidate, Neuroscience Graduate Program, University of California, Davis
9:40 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 more so 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

10:20 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.

10:45 am

PANEL SESSION: What Biotech Venture Capitalists Look for in Psychedelic Medicine Companies

How do biotech VCs evaluate a psychedelic drug development startup? The answer can unlock millions in funding. In this panel, we’ll hear from biotech firms with $100M+ fund sizes: Breakout Ventures, Jazz Ventures, and Village Global. We’ll discuss how to best pitch your company, the due diligence process, and how to position the opportunity in psychedelic medicine to traditional biotech firms. Join us for an insightful discussion hosted by PsyMed Ventures general partner and Business Trip co-host Matias Serebrinsky.
CHAIR: Matias Serebrinsky, Co-Founder, Psymed Ventures
Anne Dwane, Partner, Village Global
Amanda Way, Principal, Jazz Venture Partners
Dana Watt, Ph.D., Principal, Breakout Ventures
11:30 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

12:00 pm


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.

1:00 pm

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
CHAIR: 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

1:45 pm

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, Scientific Solutions, Worldwide Clinical Trials
2:15 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

2:45 pm

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

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

3:15 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.

3:40 pm

Trauma-informed Study Design and Facilitation in Psychedelic Research

This presentation invites the consideration of a trauma-informed approach to psychedelic research by means of study design, facilitation approach, and the attention to diversity and inclusion principles. By applying trauma-informed psychotherapeutic practices to facilitation processes such as assessment, preparation and integration of psychedelic experiences, research studies can mitigate the impact of trauma activation and dysregulation in participants suffering from PTSD or complex trauma. Study design can also mitigate the potential for traumatizing experiences through consideration of dose amount and number of sessions in each protocol. Attention to diversity and inclusion principles are important related concerns in psychedelic research to not reproduce previously established anti-ethical research practices in the medical field, holding an inclusive therapeutic frame for participants of various cultural backgrounds to safely participate in psychedelic research.
Gisele Fernandes-Osterhold, MFT, Director of Psychedelic Facilitation, Translational Psychedelic Research Program (TrPR), BAND Lab, University of California San Francisco

4:10 pm

Guidance for Conducting Large Trials with Psychedelics: When is it Safe to Resume Driving Following Administration of Psychedelics?

The purpose of this presentation will be to provide practical information useful in eventual drug labeling and in planning for large scale efficacy studies. When is it safe to return to driving following administration of a psychedelic during a trial? This presentation will address the regulatory requirements for determining when it’s safe to drive after taking medication. It will also provide participants with an understanding of the methods used to make this determination, including recent examples (case studies) from ketamine studies.
Gary Kay, Ph.D., Co-Founder & Chief Scientific Officer, Cognitive Research Corporation
4:40 pm

Reception: Hors d'oeuvres & Drinks

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