Conference Agenda

DAY ONE - MAY 4, 2021 (central daylight time)

9:30 am A Crystal-clear View of Psychedelic Drug Actions
In this talk Dr. Roth will:
- Present new findings which illuminate the 'hidden pharmacology' of psychedelic drugs and show why this information is therapeutically important
- Show how we can leverage an understanding of the molecular details of psychedelic drug actions to discover new psychedelic and non-psychedelic neuropsychiatric medications
Bryan Roth, MD, Ph.D., Michael Hooker Distinguished Professor of Pharmacology, University of North Carolina Chapel Hill School of Medicine

10:00 am Chemistry and Biology of Novel 5-HT2C/2A Agonists - Looking Beyond Lorcaserin
In this presentation, Dr. Kozikowski and Dr. Shreeniwas will discuss the following:
- Discovery of Novel 5-HT2 Agonists - Chemistry and Pharmacology
- ADME/PK Parameters
- Behavioral Biology
- Medical Indications
- Future Challenges
Alan Kozikowski, Ph.D., Chief Scientific Officer, Bright Minds
Revati Shreeniwas, MD, Chief Medical Officer, Bright Minds

10:40 am Ultra-large Library Docking for New Chemotypes with New Pharmacology
Beginning with the structure of targets like the 5HT2a receptor, libraries of 100 million to 2 billion molecules are screened for complementarity, and high ranking ones are tested for in vitro and ultimately in vivo modulation of the targets and the behavior they control. New developments that have opened up chemical space for the discovery of novel chemotypes will be considered, including the use of both ultra-large general libraries (about 2 billion molecules) as well as more focused bespoke libraries around particular scaffolds (about 75 million molecules each) will be considered.
Brian Shoichet, Ph.D., Professor, Department of Pharmaceutical Chemistry, University of California San Francisco

11:10 am Discovery and Development of New 5-HT2AR Agonists
The NBOMe-class of compounds have provided several useful tool-compounds used to interrogate the function of the 5-HT2A receptor in both preclinical and clinical research. Furthermore, data from the preclinical development of novel 5-HT2AR agonists within Lophora will also be presented.
Jesper Langgaard Kristensen, Ph.D., Professor, Medicinal Chemistry, Department of Drug Design & Pharmacology, University of Copenhagen, Chief Scientific Officer, Lophora

11:40 am Psychedelic-assisted Psychotherapy for Advanced Cancer-related Psychiatric and Existential Distress
Stephen Ross, MD, Associate Director, NYU Langone Health Center for Psychedelic Medicine

12:10 pm Lunch Break

12:40 pm The Focused Pharma Initiative: Psychedelic Research Funding for Mental Health
Tristan McClure-Begley, Ph.D., Program Manager, Focused Pharma, Defense Advanced Research Projects Agency (DARPA)

1:10 pm Psychedelics: The Next Frontier in Biotech
In this presentation, Mr. Rahn will discuss psychedelics within the context of being a new sector within the biotech industry. This will entail a discussion on the business of psychedelics and investing in the industry. Furthermore, he will address the impending mental health crisis facing the nation and the role psychedelics can play.
JR Rahn, Co-founder, Co-CEO, MindMed

1:40 pm Leveraging Data to Drive and Improve the Future of Psychedelic Medicine
The emergence of the psychedelic medicine industry is providing a unique opportunity to build a better system of psychiatric and mental healthcare, in part by leveraging data and advanced technology to guides drug development and intelligently inform patient experience. To that point, Entheon is developing a personalized system of psychedelic medicine that utilizes data analysis, while implementing the latest advancements in EEG technology and AI/machine learning platforms in order to develop a safe & effective means of administering psychedelic medicine. In addition, Timothy will speak to the challenges of bringing a scheduled drug, such as dimethyltryptamine (DMT), through a research pathway to a point of commercial readiness, while also highlighting why Entheon chose DMT as our target molecule for therapeutic application.
Timothy Ko, Chief Executive Officer, Entheon Biomedical

2:10 pm The Psychedelic Hype Cycle - Inflated Expectations, Disillusionment, and the Slope of Enlightenment
In this presentation, Eleusis founder Shlomi Raz will discuss the Gartner "Hype Cycle" as it relates to the psychiatric applications of ketamine and psilocybin, highlighting the challenges to unlocking the therapeutic potential of this emerging therapeutic class.
Shlomi Raz, Chief Executive Officer, Eleusis

2:40 pm End of Day's Presentations

DAY TWO - MAY 5, 2021 (central daylight time)

9:30 am Prolonged Epigenetic Alterations Following Single Exposure to a Psychedelic in Mice
Clinical studies report that psychedelics exert rapid and sustained antidepressant responses. Our data suggest that a single administration of the psychedelic DOI induced fast-acting effects on mouse frontal cortex dendritic spine structure and fear extinction via 5-HT2A receptor. This was associated with long-lasting changes in chromatin organization at enhancer regions of genes involved in synapse assembly, suggesting epigenetic plasticity as a critical component that contributes to the antidepressant action of psychedelics.
Javier Gonzalez Maeso, Ph.D., Professor of Physiology and Biophysics, Virginia Commonwealth University School of Medicine

10:00 am MDMA and Ketamine: Translating Mechanism into Better Therapy
Among the emerging class of rapid-acting psychiatric therapies, MDMA and ketamine have the strongest clinical evidence for efficacy. Understanding how these drugs trigger lasting behavioral transformations is the first step toward designing safer, more precise therapies. In this presentation, Dr. Heifets will review our group's efforts to define these drugs' actions in animal models, in terms of coordinated ensembles of neural circuits across the brain.
Boris D. Heifets, MD, Ph.D., Assistant Professor, Dept. of Anesthesiology, Perioperative & Pain Medicine, Stanford University School of Medicine

10:30 am Hot Topics in Psychedelic Drug Development: From Successful Clinical Trials to Maximizing Benefits in the Post-approval World
This session will bring together speakers representing government, industry, and the non-profit sector to discuss some of the biggest issues facing developers of psychedelic drugs.
Moderator: Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates

Design and Operational Challenges in Psychedelic Clinical Trials
This presentation will highlight some of the operational challenges that are unique to clinical trials with psychedelics (e.g., what is the appropriate control condition, can participants be effectively blinded, etc.).
Marion Coe, Ph.D., Scientist, Pinney Associates

Clarifying DEA Regulations for Clinical Research with Psychedelic Drugs
The DEA regulations surrounding the use of psychedelic drugs in clinical trials will then be discussed, including process for import/export licenses, obtaining schedule licenses, clarifying scheduling of certain compounds (e.g., precursors, new compounds, analogs), and how approved drugs are scheduled.
Speaker to be Announced

Psychedelics in the Post-approval World: Scheduling, REMS, Treatment Models, Cost, and Access Issues
In this presentation the speaker will explore more broadly post-approval issues including potential REMS, different treatment paradigms and their impact on final patient cost.
Rick Doblin, Ph.D., Founder & Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Ensuring Equitable Access to Psychedelics for People of Color, Indigenous Populations, and the Disadvantaged: Pre and Post Approval
Our presenter will discuss strategies to increase minority participation in clinical trials as well as ways to ensure that historically disadvantaged peoples are able to access approved psychedelic drugs.
Speaker to be Announced

12:30 pm Lunch Break

1:00 pm Hot Topics in Psychedelic Drug Development: Panel Discussion
Moderator: Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates
Rick Doblin, Ph.D., Founder & Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)
Marion Coe, Ph.D., Scientist, Pinney Associates
Jack Henningfield, Ph.D., Vice President, Research, Health Policy, and Abuse Liability , Pinney Associates
Panelist to be Announced

1:30 pm Operational Considerations for the Administration of Moderate Doses of LSD: Quantitative and Qualitative Perspectives of Safety
In this presentation, Neiloufar Family, will discuss Eleusis' Phase 1b LSD trial, which evaluated the safety, pharmacokinetics, and subjective effects of 50 µg, 75 µg and 100 µg lysergic acid diethylamide (LSD) in healthy adults within an interventional paradigm. She will present safety results, participant perspectives, and operational implications for the delivery of psychedelic therapies.
Neiloufar Family, Ph.D., Psychiatric Research Director, Eleusis

2:00 pm Potential Mechanisms Underlying Psilocybin Therapy for Major Depressive Disorder
Psilocybin therapy has shown potential efficacy in treating a variety of etiologies and presentations of mood disorders. We will review the evidence for efficacy of psilocybin therapy in patients with major depressive disorder. We will also review potential directions for understanding psychological and neural mechanisms that may underlie the therapeutic efficacy of psilocybin therapy.
Frederick Barrett, Ph.D., Assistant Professor of Psychiatry and Behavioral Sciences, Center for Psychedelic and Consciousness Research, Behavioral Pharmacology Research Unit, Johns Hopkins School of Medicine

2:30 pm Psychedelics as Powerful Anti-inflammatory Therapeutics
In this presentation Dr. Nichols will discuss the discovery of psychedelics as anti-inflammatories in his laboratory, what they have learned about the underlying mechanisms, therapeutic efficacy in various rodent models of human inflammatory related diseases, and discovery efforts to develop new potent anti-inflammatory psychedelics with reduced behavioral effects.
Charles Nichols, Ph.D., Professor, Department of Pharmacology & Experimental Therapeutics, LSU Health Sciences Center

3:00 pm End of Conference