2026 Conference Agenda

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Peter Hendricks, Ph.D., University Professor and Heersink Endowed Chair, Department of Psychiatry and Behavioral Neurobiology, University of Alabama Birmingham, Co-Founder, Equulus Therapeutics

5-HT2A receptor activation by classical psychedelics such as LSD, psilocybin, and mescaline is the main driver of these compounds’ hallucinogenic effects, but their therapeutic and side-effect profiles may involve more complex mechanisms. In this talk, we explore the polypharmacology of 41 psychedelics across three chemical classes, profiling their interactions with over 300 human GPCRs. Our findings reveal that these compounds act broadly on serotonin, dopamine, and adrenergic receptors and engage multiple signaling transducers. These insights challenge the notion of a single receptor mechanism and highlight how diverse molecular targets may shape both psychedelic experiences and therapeutic outcomes.
Ryan Gumpper, Ph.D., Assistant Professor, Eshelman School of Pharmacy, University of North Carolina Chapel Hill

This presentation introduces Neurala Biosciences’ platform for next-generation DMT–harmala therapeutics designed for substance use and psychiatric disorders. It will outline the scientific rationale for our approach, including structurally refined compositions and formulations with unique flexibility to deliver short-acting and long-acting formats, together with broader therapeutic profiles than classical psychedelics. Recent preclinical and phase 1 findings will provide context for our advancing clinical programme, including studies in alcohol use disorder and major depressive disorder.
Daniel Perkins, Ph.D., Head, Psychedelics Research & Therapeutics Unit/Chief Executive Officer, University of Melbourne/Neurala Biosciences

The psychedelic therapeutics field is shifting rapidly toward neuroplastogens—compounds that drive rapid, durable neuroplasticity without the safety liabilities or operational burdens of classical psychedelics. EQUULUS Therapeutics is advancing the ultimate-generation, non-hallucinogenic and non-cardiotoxic ibogaine analog designed to deliver ibogaine-like efficacy while removing the barriers that have limited its adoption. By decoupling neuroplasticity from cardiotoxicity and the psychedelic trip, this molecule is engineered for true clinical scalability, supporting outpatient delivery, global access, and payer alignment. These attributes, combined with a clear regulatory path, position the program as an unusually pharma-ready psychedelic-inspired therapeutic. This presentation will outline the scientific basis of our design and why de-risked, scalable psychedelic analogs are now among the most attractive assets for big-pharma CNS pipelines.
Bob Discordia, Ph.D., Co-Founder & Chief Executive Officer, Equulus Therapeutics

Julia Forte, Executive Director, Project Management, Worldwide Clinical Trials

Noah Craft, MD, Ph.D., Co-Founder & Co-CEO, People Science

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Charles Nichols, Ph.D., Professor, Department of Pharmacology and Experimental Therapeutics/Co-founder & Chief Science Officer, LSU Health Sciences Center/2A Biosciences

Psychedelic Alpha Editor Josh Hardman delivers a State of the Union for the psychedelics field: from funding dynamics and the drug development pipeline through to policy reform efforts, pre-approval access pathways and key trends. He ends by providing a look ahead to select challenges and questions that the field must grapple with, before turning to audience questions. If Hardman can’t answer your question, he vows to do his best to connect you with someone who can.
Josh Hardman, Founder & Editor, Psychedelic Alpha

Psychedelic treatments are rapidly moving from research into clinical practice, signaling a potential transformation in how we treat mental health conditions. Compass Pathways' Chief Patient Officer, Dr. Steve Levine, will speak about how the company is preparing for this new future with a focus on how Compass is bridging the patient experience from clinical trial settings to real-world care, enabling patient access and overall commercial preparations.
Steve Levine, MD, Chief Patient Officer, Compass Pathways

Kathryn Cunningham, Ph.D., FASPET, Professor & Vice Chair, Dept. of Pharmacology & Toxicology; Director, Center for Addiction Sciences & Therapeutics, University of Texas Medical Branch

Historically, CNS drug development has been plagued by translational challenges which make it difficult to predict drug effect, target engagement, and dose selection. Electroencephalography (EEG) is often used for measuring brain penetrance and receptor-engagement in preclinical drug-discovery. As an objective measure, the hope is that EEG results obtained in animal models will translate to first in human studies, making quantitative EEG (qEEG) a powerful translational biomarker in drug development. In this talk, Dr. John Huxter, Global Head of EEG and Data Science at Transpharmation, and Dr. Florentine Barbey, Senior Scientist, Cumulus Neuroscience, present a cross-species comparison and analysis of the NMDA receptor antagonist ketamine’s effect on the brains of mice, rats, dogs and humans.
John Huxter, Ph.D., Global Head of EEG and Data Science, Transpharmation
Florentine Barbey, Ph.D., Senior Scientist, Cumulus Neuroscience

Psychedelics' therapeutic potential may hinge on understanding what shapes their acute subjective effects linked to therapeutic outcomes. Psychedelic session facilitators, individuals who support participants during psychedelic administration sessions, are core parts of psychedelic trials and thus form an important part of the setting of these experiences. Yet, the extent to which they influence participants' acute subjective effects is unknown. To address this gap, we analyzed data from 9 psilocybin administration studies conducted at the Johns Hopkins Center for Psychedelic and Consciousness Research, involving 298 participants, 670 dosing sessions, and 60 facilitators—the largest dataset of its kind.
Sean Goldy, Ph.D., Postdoctoral Fellow, Johns Hopkins University School of Medicine

With psychedelic-assisted therapy becoming more mainstream and gaining momentum in clinical trials, there are still key questions surrounding about which next-generation psychedelics are suited for certain clinical outcomes. Our lab is involved in uncovering common pitfalls that lead to poor translational outcomes in predicting psychedelic effects at the early drug discovery phase. To address the translation gap regarding psychedelic drug discovery, this presentation will detail drug discovery platforms and workflows that can be used to refine predictions about psychedelic efficacy and make predictions on favorable or unfavorable off-target activities that influence next-generation psychedelic pharmacological profiles. Importantly, we show species differences at several serotonin receptors that play a role in choosing the proper species for IND-enabling and proof-of-concept validation for in vivo target engagement. Finally, we expand this tool kit toward other compound scaffolds and show examples where more information may be needed to predict pharmacodynamic-pharmacokinetic relationships to ensure proper designation of potential hit-to-lead compounds in the pipeline.
John McCorvy, Ph.D., Associate Prof., Cell Biology, Neurobiology & Anatomy, Medical College of Wisconsin

Expansion in recent years of medical models, state regulated programs, spiritual/religious ceremonies and decriminalization are increasing access to psychedelics. More people are encountering psychedelics, whether they use these substances themselves, interact with someone who is under the influence, or are guiding/facilitating someone through an experience. Psychedelics have mind-altering effects that also can render a vulnerable state and can create opportunities for adverse interpersonal experiences. Abuse has been documented even in rigorous clinical trial settings. Using the 2025 data from the National Survey Investigating Hallucinogenic Trends (NSIHT), this presentation will showcase US population prevalence data for the reasons why adults have used psychedelics in the naturalistic settings, and the reports of sexual and physical assault while under the influence of psychedelics. The factors associated with these experiences, which substances were involved, and the reported perpetrators of the assault will be shown. These self-report adverse interpersonal experiences will be compared to other settings, such as psychotherapy or educational settings, and explore the relationship of certain risk factors in other assault contexts (housing status, history of substance use disorders, gender identity, etc.).
Kari Rockhill, Ph.D., MPH, Assistant Statistical Scientist, Rocky Mountain Poison & Drug Safety

As Food and Drug Administration (FDA) approval of psychedelics as medicines becomes increasingly plausible, there is a pressing need to move beyond questions of efficacy and grapple with the real-world challenges of integrating these treatments into routine clinical care. This talk draws on the speaker’s experience leading Cleveland Clinic’s Psychiatric Treatment-Resistance Program and associated esketamine service, serving as site principal investigator for multiple psychedelic clinical trials, and conducting research on service delivery and billing and reimbursement for ketamine, esketamine, and emerging psychedelic treatments. Key themes include clinicians’ evolving attitudes toward psychedelics, the practical realities of patient selection and risk mitigation, persistent workforce and training gaps, and the critical role of billing codes and reimbursement in determining access. Lessons from ketamine and esketamine suggest that without deliberate planning around infrastructure, clinician education, reimbursement, and equitable access, the clinical rollout of psychedelics risks repeating familiar mistakes that could prevent these compounds from realizing their full therapeutic potential.
Brian Barnett, MD, Assistant Professor of Psychiatry, Cleveland Clinic

Psychedelic science needs objective, scalable endpoints that bridge subjective reports with brain dynamics. We present a unified EEG framework that includes complexity, connectivity, and affective/arousal indices to quantify both acute and sub-perceptual states. Using a harmonized pipeline, we report converging findings from an intravenous DMT study in healthy participants (N=13) and a longitudinal LSD microdosing study conducted as well on healthy participants (N=53). Implications for clinical translation are twofold. First, EEG complexity and connectivity provide mechanistic, quantifiable endpoints that complement symptom scales for psychedelic clinical trials, supporting dose selection, timing, and evaluation of therapeutic windows. Second, subject-level prediction becomes feasible through the combination of complexity and affective markers, enabling prospective estimation of whether an individual is experiencing a psychedelic effect. By unifying markers within one reproducible EEG framework, we provide standardized endpoints and predictive tools to enhance assay sensitivity, preserve blinding, and strengthen safety monitoring, advancing well-powered, regulator-ready psychedelic clinical trials.
Aureli Soria-Frisch, Ph.D., Neuroscience Unit Director, Starlab

Psilocybin-assisted therapy has been shown in clinical trials to reduce the symptoms of major depressive disorder (MDD) and alcohol use disorder (AUD). If approved, the adoption of this novel therapy will depend in part to their economic value compared to existing treatments. Using economic modeling and evidence from clinical trials, we assessed the cost-effectiveness of psilocybin-assisted therapy for MDD, difficult-to-treat depression (DTD), and AUD. We also identified the specific conditions (e.g., maximum cost and minimum effectiveness of therapy) that are required for psilocybin-assisted therapy to meet the commonly used thresholds of value in the US.
Anton Avanceña, Ph.D., Assistant Professor of Health Outcomes, University of Texas at Austin College of Pharmacy

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Current enthusiasm for non-hallucinogenic 5-HT2A agonists assumes that removing psychedelic effects will preserve the therapeutic impact seen in psychedelic-assisted psychotherapy for depression and anxiety. However, convergent evidence from clinical, psychological, and neuroimaging research suggestst that the sustained improvements in mood and well-being observed after full psychedelic sessions correlate with acute psychological and neural effects. Using insights from neuropharmacology, systems neuroscience, and fMRI, this talk argues that serotonergic receptor engagement without high-level network disintegration is unlikely to yield lasting change in psychiatric contexts. Yet, the same molecular and neuroplastic mechanisms - 5-HT2A- and 5-HT1A-mediated neurotrophic signaling, anti-inflammatory cascades, and sigma-1-linked mitochondrial effects - may, instead, be ideally suited for TBI and neurodegenerative indications, where therapeutic goals are regenerative rather than psychotherapeutic. This presentation outlines a new translational rationale: non-hallucinogenic serotonergic modulators as agents of controlled neurorepair.
Manesh Girn, Ph.D., Co-Founder and Chief Executive Officer, FIVE Discovery

Peter Hendricks, Ph.D., University Prof. & Heersink Endowed Chair, Dept. of Psychiatry & Behavioral Neurobiology , University of Alabama Birmingham

Panelists will explore emerging scientific directions, evolving clinical and translational priorities, and the practical challenges that can slow development, from trial design and endpoints to operational and regulatory considerations. The session will highlight promising areas of investigation, share lessons learned from recent studies, and offer a grounded view of near-term opportunities to strengthen evidence generation and accelerate advancement in the field.

Moderator:
Peter Hendricks, Ph.D., University Professor & Heersink Endowed Chair, Dept. of Psychiatry & Behavioral Neurobiology, University of Alabama Birmingham, Co-Founder, Equulus Therapeutics

Panelists:
Kathryn Cunningham, Ph.D., FASPET, Professor & Vice Chair, Dept. of Pharmacology & Toxicology; Director, Center for Addiction Sciences & Therapeutics, University of Texas Medical Branch
Charles Nichols, Ph.D., Professor, Department of Pharmacology and Experimental Therapeutics, LSU Health Sciences Center
John McCorvy, Ph.D., Associate Professor, Cell Biology, Neurobiology & Anatomy, Medical College of Wisconsin

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