Kevin Balktick

Founder + Director

Horizons Media, Inc.

Psychedelics (once again) appear poised to enter the US healthcare industry. Before diving into the arcanum of billing codes, REMS, and labels, it is worth taking a moment to take a step back and examine the systems through which these special molecules will flow, and how this labyrinth can fulfill or diminish our most fundamental human needs.

Josh Hardman

Founder & Editor

Psychedelic Alpha

Nearly ten years after the FDA first granted Breakthrough Therapy Designation to a psychedelic therapy program and six months after the Executive Order prioritizing regulatory decisions and research funding for psychedelic medicine, where does the field actually stand?

In this opening session, Josh Hardman steps back from the news cycle to ground the day ahead, mapping the drug development pipeline, the policy landscape, and the shape of the funding ecosystem; plus the essential questions shaping what comes next.

Matthew Zorn, JD

Deputy General Counsel

U.S. Department of Health and Human Services

Moderator

Josh Hardman

Founder & Editor

Psychedelic Alpha

Matthew (Matt) Zorn currently serves as Deputy General Counsel at the U.S. Department of Health and Human Services (HHS), a position he has held since May 2025.

Before entering HHS, Matt served for 13 years as a trial and appellate litigator and former partner at Yetter Coleman LLP in Houston, TX, where his practice focused on commercial litigation, with an emphasis on IP, antitrust, and administrative law matters.

Matt is also recognized as a national authority on legal issues relating to controlled substances. In that area, he led numerous successful lawsuits against federal agencies and state governments, including against HHS, DOJ, and the DEA, challenging agency rules and enforcement actions on behalf of scientists, physicians, and military veterans. He also served as an adjunct professor at the University of Houston Law Center, where he taught the school's first course on cannabis and psychedelics law.

Matt has received national recognition for his work. His high-profile cases and commentary have been featured in the New York Times, the Washington Post, and major media outlets.

Al Bugazia, MD

Deputy Director, Proactive Health

ARPA-H

Andrew Gradison, JD

Senior Advisor, Veterans Health Administration

U.S. Department of Veterans Affairs

Valentina Mantua, MD, PhD

Associate Director for Regulatory Science

U.S. Food and Drug Administration

Moderator

Erin Schumaker

Deputy Health Care Editor

Politico

After decades of academic and industry studies, several psychedelic drug candidates are likely to be evaluated for regulatory approval in the months to come.

In this session, representatives of several federal bodies discuss how they have arrived at their current framework regarding psychedelic medicine, their plans for the next year, and the essential questions that remain unanswered.

Ritu S. Baral

Managing Director & Sr. Biotechnology Analyst

TD Cowen

Edny Inui, PhD, MBA

Partner

Palo Santo

Connor Williams

Senior Research Analyst

RTW Investments

Moderator

Madison Muller

Healthcare Reporter

Bloomberg News

Following an era of exuberance fueled by retail investors, ZIRP, and splashy headlines in 2020 and 2021, financing for psychedelic concerns entered a period of malaise that conclusively ended with news of a multibillion-dollar acquisition deal in July 2026.

In this warmer regulatory climate and with numerous candidates reaching the end of their trials, a new wave of opportunities and announcements across all stages of the drug development pipeline and commercialization seems imminent.

In this session, seasoned biotech investors will distill insights from today’s complex cloud of indicators and questions.

A.J. Cannon, MD

Medical Director, Neuroscience Clinical Development

AbbVie

Daniel R. Karlin, MD, MA

Chief Medical Officer

Definium Therapeutics

Srinivas Rao, MD, PhD

Co-Founder and Chief Executive Officer, AtaiBeckley

Eli Lilly and Company

Moderator

Kyle LaHucik

Biotech Correspondent

Endpoints News

Decades of effort have finally produced a clear view of what it takes to bring a psychedelic drug candidate from aspiration through pre-clinical work to final Phase 3 endpoints.

Against the backdrop of this growing body of data, several high-profile M&A deals have closed, and many candidates have inched closer to approval– while not a few other sponsors and their candidates have evaporated.

In this session, drug development leaders share lessons learned, current priorities, and predictions about the next round of discovery, trials, and market responses.

Lori Englebert

Chief Commercial Officer

Compass Pathways

Jeffrey Zabinski, MD, MSW

Director of Interventional Psychiatry

Columbia University Irving Medical Center

Moderator

Jazz Glastra

Senior Director

BrainFutures

With numerous promising candidates having completed or in the midst of Phase 3 trials, both drug developers and their critical go-to-market partners are planning for commercialization.

While FDA approval is certainly the most significant checkpoint in the journey, it is also merely the first domino in a long sequence leading to treating patients and generating revenue.

In this session, we hear how psychedelic drug developers and novel treatment implement experts are preparing to translate the promise of research into clinical reality.

Lee Lewis

Chief Strategy Officer and GM Medical Solutions, Health Transformation Alliance

Health Transformation Alliance

Tanya Brara Shah

Strategic Advisor

Psychedelic Mental Health Access Alliance

Moderator

Jazz Glastra

Senior Director

BrainFutures

Reimbursement is the hinge on which broad access — and the financial viability of the drug development and clinical ecosystem — will turn.

In some ways, these new drugs and their accompanying treatments are no more expensive or complex than common medical treatments in other specialities. However, in other regards, including their public perception, they are sui generis.

In this session, payer and market-access experts will raise the crucial questions about how, when, and how much public and private insurance reimbursement might be achieved – and how this affects the viability of the entire field.

Austin R. Pick, MA

Program Director

Psychedelic Education Partnership

Sandy Samberg, NP

Founder and Board Chair

Psychedelic Education Partnership

Over the last decade, while rivers of capital have flowed into drug development, professional education has remained neglected by the industry that will depend on it.

Recently, the Psychedelic Education Partnership has emerged as a leader in education for the full spectrum of the healthcare workforce by working in partnership with existing institutions.

The urgent need for education ranges from existing general practitioners who may be asked about referrals to students who hope to spend their careers in this field.

In this session, we’ll learn about this growing endeavor that already has over 180 participating faculty members from 70 universities across 35 US states, Washington, DC and Puerto Rico.

Myriam Barthes

CEO & Co-Founder

Journey Clinical

Daniel Bryant, MSEd, LPC, CCTP

Clinical Director of Substance Use Disorder Services

Community Health Center, Inc.

Kimberly Roddy, MBA

Interim CEO, Co-Founder

Sunstone Therapies

William M. Sauvé, MD

Chief Medical Officer

Osmind

Moderator

Joy Sun Cooper

Senior Advisor

Psychedelic Science Funders Collaborative

At the end of the day, psychedelic medicine ultimately relies upon skilled practitioners, safe places of care, and healthy organizations to support them.

What has been learned from psychedelic trials? How might the provision of psychedelic therapies draw on that of other therapies, and how may it differ? How prepared is the industry for the day when theory meets practice in a post-approval world?

Join us as we hear what leaders across the care delivery landscape believe will be needed to deliver safe, effective care at scale while staying in the black.

Carole Ho, MD

Executive Vice President; President, Lilly Neuroscience

Eli Lilly and Company

Moderator

Josh Hardman

Founder & Editor

Psychedelic Alpha

Carole Ho, MD is executive vice president of Eli Lilly and Company and president of Lilly Neuroscience. Throughout her career, Carole has guided teams through the full spectrum of drug development, driving progress from early research to pivotal clinical milestones and global launches.

Before joining Lilly, Carole was the founding chief medical officer and head of development at Denali Therapeutics, where she established a dynamic development infrastructure that accelerated progress across multiple neurological indications.

Throughout her career, Carole has championed innovative approaches to clinical research, spearheaded landmark prevention trials, and cultivated partnerships that have shaped the future of neuroscience. Carole completed her residency in neurology at Massachusetts General Hospital/Brigham and Women’s Hospital, where she also served as chief resident. She obtained her M.D. from Cornell University and S.B. in Biochemical Sciences from Harvard College.

Following the close of the Psychedelic Healthcare Forum, we invite Industry attendees to join us in the Reading Room on the 3rd floor for a celebration with hors d’oeuvres and drinks.

Kevin Balktick

Founder + Director

Horizons Media, Inc.

With the recent and upcoming completion of several Phase 3 studies that investigate numerous psychedelics for the treatment of several mental health indications and ongoing quest to identify the loci of their remarkable effects, a number of fault lines have emerged in the scientific, medical, and patient communities. Before we dive into a day of facts and findings, let us ponder the different ways in which one might approach this growing mountain of data.

Andrea Beckel-Mitchener, PhD

Acting Director, National Institute of Mental Health

National Institutes of Health

Valentina Mantua, MD, PhD

Associate Director for Regulatory Science

U.S. Food and Drug Administration

Moderator

Julie Holland, MD

Psychiatrist and author

Private practice, New York City

Andrea Beckel-Mitchener, PhD, Acting Director of the National Institute of Mental Health (NIMH) and Deputy Director of the NIH BRAIN Initiative, joined NIH in 2004 and has led major neuroscience programs, including NIMH's Functional Neurogenomics program and the BRAIN Initiative Cell Census Network. She holds a PhD in Molecular Neuroscience from the University of New Mexico.

Valentina Mantua, MD, PhD, Associate Director for Regulatory Science in the Office of Neuroscience at the FDA's Center for Drug Evaluation and Research, joined the agency in 2019 after serving as the Italian delegate to several European Medicines Agency committees. A psychiatrist, she holds a PhD in the neurobiology of affective disorders.

Manesh Girn, PhD

Postdoctoral Neuroscientist

University of California, San Francisco (former)

Psychedelic drugs are re-emerging as promising scientific and clinical tools. However, despite a rapidly expanding literature on their therapeutic value, the neural mechanisms underlying psychedelic effects remain unclear.

Resting-state functional magnetic resonance imaging studies of acute psychedelic effects, conducted independently by several research groups, have so far yielded fragmented and sometimes inconsistent findings.

To help facilitate greater convergence, we conducted a ‘mega-analysis’ integrating 11 independent resting-state functional magnetic resonance imaging datasets across five psychedelic drugs (psilocybin, lysergic acid diethylamide, mescaline, N,N-dimethyltryptamine and ayahuasca) from research groups spanning three continents and five countries.

Together, these findings extend past work by demonstrating that psychedelics reconfigure large-scale cortical organization while selectively engaging subcortical circuitry. This study provides the most comprehensive synthesis of psychedelic brain action to date, helping resolve inconsistencies and offering a probabilistic map of how psychedelics alter large-scale brain organization.

Citation: Girn, M., Doss, M. K., Roseman, L., Preller, K. H., Palhano-Fontes, F., Pasquini, L., Barrett, F. S., Mallaroni, P., Mason, N. L., Timmermann, C., McCulloch, D. E., Fisher, P. M., Winston, B. S., Moujaes, F., Muller, F., Liechti, M. E., Vollenweider, F. X., Ramaekers, J. G., Kuypers, K., ... Bzdok, D. (2026). An international mega-analysis of psychedelic drug effects on brain circuit function. Nature medicine, 32(4), 1543-1554. https://doi.org/10.1038/s41591-026-04287-9

Guy Goodwin, MD, DPhil

Chief Medical Officer; Emeritus Professor, Oxford

Compass Pathways

Dr. Guy Goodwin, Chief Medical Officer of Compass Pathways and Emeritus Professor of Psychiatry at the University of Oxford, will provide an overview of the COMP360 clinical development program in treatment-resistant depression (TRD), including two Phase 3 trials involving more than 800 participants from multiple countries.

The session will examine the evolution of research in TRD, including considerations in clinical trial design, the development of investigational treatment approaches, and the broader scientific landscape.

Dr. Goodwin will discuss the scope of the COMP360 program, ongoing areas of investigation, and considerations for future research in serious mental health conditions.

COMP360 is a synthetic psilocybin treatment under investigation for the treatment of mental health conditions, including TRD and PTSD.

References

ClinicalTrials.gov — COMP005 (NCT05624268)

ClinicalTrials.gov — COMP006 (NCT05711940)

Rachel Yehuda, PhD

Chemers Neustein Family Professor of Trauma and Resilience

Icahn School of Medicine at Mount Sinai

As large-scale studies of psychedelic therapy mature, the field is in the midst of confronting a validation problem shared across psychiatry: treatment response is still measured almost entirely through self-report symptom scales. The next generation of trials, for psychedelics and for mental health treatments generally, can expect to integrate objective biomarker and neuroimaging correlates that can supplement questionnaires with objective, measurable evidence.

Rachel Yehuda's lab has spent decades investigating biological evidence for trauma treatment, such as DNA methylation changes on stress-related genes and structural brain differences in the hippocampus and cingulate cortex that distinguish PTSD from trauma exposure without it.

As a co-investigator on MAPS' Phase 3 MDMA trial, her group ran an early pilot testing whether these molecular markers shift with MDMA-assisted therapy specifically, one of the first attempts to give a psychedelic trial a biological outcome measure alongside its clinical one.

She now leads several active trials at Mount Sinai applying this approach directly, including psilocybin- and MDMA-assisted therapy studies in veterans, healthcare providers, and the adult children of genocide survivors. Dr. Yehuda will discuss where she sees psychedelic and psychiatric outcome measures heading next, and what a biomarker- and neuroimaging-informed generation of trials could add to the field.

References

• A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy for Mental Healthcare Providers. NCT07102576. ClinicalTrials.gov.
• A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans. NCT06418178. ClinicalTrials.gov.
• Processing Intergenerational Trauma With Psilocybin-Assisted Therapy. NCT06899165. ClinicalTrials.gov.
• Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder. NCT06592833. ClinicalTrials.gov.
• Holocaust Exposure Induced Intergenerational Effects on FKBP5 Methylation. Yehuda R, Daskalakis NP, Bierer LM, et al. 2016;80(5):372–380. DOI: 10.1016/j.biopsych.2015.08.005.
• Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD. Lewis CR, Tafur J, Spencer S, et al. 2023;14:959590. DOI: 10.3389/fpsyt.2023.959590.
• Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. McGowan NM, Rucker JJ, Yehuda R, et al. 2026;40(1):139–148. DOI: 10.1177/02698811251362390.
• Cingulate and hippocampal subregion abnormalities in combat-exposed veterans with PTSD. Szeszko PR, Bierer LM, Bader HN, et al. 2022;311:432–439. DOI: 10.1016/j.jad.2022.05.081.

Juliana Zambrano, MD, MPH

Instructor of Psychiatry, Harvard Medical School

Massachusetts General Hospital

Irritable bowel syndrome is a common and often disabling disorder of gut-brain interaction involving abdominal pain, altered bowel function, stress, mood, and the perception of bodily sensations. Many people continue to experience substantial symptoms despite available medical and behavioral treatments.

Investigators at Massachusetts General Hospital recently completed the principal phase of a pilot study of psilocybin-assisted therapy for IBS. Juliana Zambrano, MD, MPH, will present preliminary quantitative findings alongside participants’ qualitative accounts, examining both measurable symptom changes and how people described the treatment experience.

By bringing gastrointestinal symptoms, pain, mood, neuroplasticity, and lived experience into a common framework, the study asks whether psychedelic-assisted therapy might address several dimensions of IBS at once. It also offers a way of thinking about disorders of gut-brain interaction that moves beyond a simple division between “physical” and “psychological” illness.

References

• Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS). NCT06206265. ClinicalTrials.gov.

Anthony L. Back, MD

Professor of Medicine

University of Washington, Seattle

People living with metastatic and incurable cancer often experience anxiety, depression, and existential distress alongside their physical illness. Most studies of psilocybin therapy have used an individual treatment model, which can be resource-intensive and may overlook the therapeutic possibilities of community and shared experience.

In a Phase 1/2 study, Anthony L. Back, MD, and colleagues developed a group model in which participants prepared and integrated together, with psilocybin administered during a three-day residential retreat. The model draws on the structure of rites of passage, translating elements of separation, transition, and return into a secular therapeutic setting.

This presentation examines the safety, feasibility, and preliminary outcomes of the retreat model, as well as the roles that group cohesion, mutual recognition, and social support may play in the therapeutic process. The study raises a broader question: are community and ritual simply containers for psychedelic therapy, or active components of its effects?

References

• A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer. NCT05847686. ClinicalTrials.gov.
• Group Retreat Psilocybin Therapy for People with Metastatic Cancer with Symptoms of Anxiety and Depression: Safety and Efficacy Outcomes of a Phase 1/2 Study. Back AL, McGregor BA, Thorn LL, et al. 2026. DOI: 10.1177/28314425251413856. Psychedelic Medicine.
• Group Retreat Psilocybin Therapy for People with Metastatic Cancer with Anxiety and Depression: A Rite of Passage Facilitation Model for a Phase 1/2 Study. Back AL, McGregor BA, Billingsley L, et al. 2026;4(3):222–230. DOI: 10.1177/28314425251404460. Psychedelic Medicine.

Meghan DellaCrosse, PsyD

Affiliate Scientist

Johns Hopkins Center for Psychedelic and Consciousness Research

Albert Garcia-Romeu, PhD

Psychologist and Pharmacology Researcher

Johns Hopkins Center for Psychedelic and Consciousness Research

Post-treatment Lyme disease and early Alzheimer’s disease are clinically distinct conditions, but both can involve depression, anxiety, cognitive changes, physical symptoms, and diminished quality of life. Effective treatments for this broader burden of illness remain limited.

Albert Garcia-Romeu, PhD, and Meghan DellaCrosse, PsyD, will discuss an open-label pilot study of 20 people with post-treatment Lyme disease and an ongoing pilot study of people with depression and mild cognitive impairment or early Alzheimer’s disease. Both protocols combine two psilocybin sessions with preparation, psychological support, and follow-up.

In the Lyme disease study, participants reported improvements in overall symptom burden, quality of life, mood, fatigue, sleep, and pain, with some changes sustained through six months. The Alzheimer’s study asks whether a similar intervention can be delivered safely and whether it may improve depression and quality of life in the context of cognitive decline. Together, the studies explore how mood, cognition, pain, psychological flexibility, and the experience of illness may relate to one another.

References

• Effects of Psilocybin in Post-Treatment Lyme Disease. NCT05305105. ClinicalTrials.gov.
• Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer’s Disease. NCT04123314. ClinicalTrials.gov.
• Pilot study of psilocybin in patients with post-treatment lyme disease. Garcia-Romeu A, Naudé GP, Rebman AW, et al. 2026;16:7497. DOI: 10.1038/s41598-026-38091-9. Scientific Reports.

Gisele Fernandes-Osterhold, LMFT

Director of Psychedelic Facilitation, TrPR Program

University of California San Francisco (UCSF)

People living with chronic pain, Parkinson’s disease, and serious mood disorders often experience more than a single, isolated symptom. Pain, depression, anxiety, physical limitation, cognitive changes, and the loss of meaning or identity can become deeply intertwined.

Across recent and ongoing studies, University of California, San Francisco investigators have examined psilocybin therapy for mood dysfunction in Parkinson’s disease, depression in bipolar II disorder, and chronic pain. These early studies combine carefully supported psilocybin sessions with quantitative assessments and close attention to participants’ lived experiences.

In a published open-label Parkinson’s pilot, 12 participants received two doses of psilocybin with psychotherapy. No serious adverse events, medical interventions, worsening of Parkinson’s symptoms, or exacerbation of psychosis were observed; preliminary improvements in depression and anxiety persisted through three months. Gisele Fernandes-Osterhold, LMFT, will consider what these studies suggest about symptom relief, quality of life, meaning-making, and a person’s relationship to illness—even when the underlying disease remains.

References

• Psilocybin Therapy for Depression and Anxiety in Parkinson’s Disease. NCT04932434. ClinicalTrials.gov.
• Psilocybin therapy for mood dysfunction in Parkinson’s disease: an open-label pilot trial. Bradley ER, Sakai K, Fernandes-Osterhold G, et al. 2025;50(8):1200–1209. DOI: 10.1038/s41386-025-02097-0. Neuropsychopharmacology.
• Psilocybin Therapy for Depression in Bipolar II Disorder. NCT05065294. ClinicalTrials.gov.
• Psilocybin With Intracranial Neural Sensing. NCT06919640. ClinicalTrials.gov.

Anthony L. Back, MD

Professor of Medicine

University of Washington, Seattle

Meghan DellaCrosse, PsyD

Affiliate Scientist

Johns Hopkins Center for Psychedelic and Consciousness Research

Gisele Fernandes-Osterhold, LMFT

Director of Psychedelic Facilitation, TrPR Program

University of California San Francisco (UCSF)

Albert Garcia-Romeu, PhD

Psychologist and Pharmacology Researcher

Johns Hopkins Center for Psychedelic and Consciousness Research

Juliana Zambrano, MD, MPH

Instructor of Psychiatry, Harvard Medical School

Massachusetts General Hospital

Moderator

Julie Holland, MD

Psychiatrist and author

Private practice, New York City

Psilocybin therapy is being studied across conditions that differ greatly in symptoms, prognosis, and lived experience.

The discussion will look beyond whether symptom scores improved to ask what changed for participants and how those changes might be understood. What patterns recur across studies, and where do the conditions or treatment models produce important differences? The panel will consider how psychological experience, group support, meaning-making, and biological effects may relate to one another, while also asking what these early findings can and cannot establish about mechanisms of action.

Jamila Hokanson, MD, MBA, MHA

Director of Operations, Yale Program for Psychedelic Science

Yale School of Medicine, Department of Psychiatry

Amy Lehrner, PhD

Assistant Professor of Psychiatry

Icahn School of Medicine at Mount Sinai

Over the last twenty years, headlines have focused on the healing potential of psychedelic medicine as evidenced by a growing body of clinical trials and a stellar array of advocates.

However, below the fold, there is much to discuss about trials that have found negative, null, ambiguous, or middling outcome measures and case studies. Even within the most successful studies, there exist many hopeful participants for whom the treatment failed. And in some cases, properly administered treatments do result in adverse outcomes.

While ethical misconduct and its harms emerged as a hot topic recently, there has been greater reluctance to talk about the more mundane and statistically common negative scenarios.

Variable efficacy and safety outcomes are normal in the study and practice of medicine– just ask any surgeon or oncologist. Join us as we strengthen our understanding of psychedelic medicine by learning from data that may disappoint but is nonetheless valuable.

Dalibor Sames, PhD

Professor of Chemistry

Columbia University

Ibogaine is a psychoactive, oneiric alkaloid from the West African Iboga plant that has attracted interest for its apparent ability to rapidly interrupt opioid dependence and treat several serious psychiatric and neurological disorders. Yet no single established mechanism explains the breadth or persistence of these effects. Unlike many conventional central nervous system drugs, ibogaine does not appear to work through any primary receptor or other molecular target.

Neurochemistry professor Dalibor Sames, PhD, and colleagues at Columbia University, proposes a novel “matrix pharmacology” model in which ibogaine’s effects arise from a seemingly coordinated pattern of distributed modulations that occur outside the canonical receptor interactions, including complex regulation of serotonin and monoamine signaling.

Drawing on laboratory research, preclinical evidence, and emerging clinical observations, Dr. Sames will examine the foundations of this theory, how it can be tested and whether it can guide design of safer iboga-inspired medicines and treatments. The larger question arises whether ibogaine is an unusually complex drug, or rather a lead to an entirely new paradigm of thinking and designing therapeutic and health-enhancing molecular technologies.

References

Deciphering Ibogaine’s Matrix Pharmacology: Multiple Transporter Modulation at Serotonin Synapses*. Hwu C, Havel V, Westergaard X, et al. 2026;148(1):175–193. DOI: 10.1021/jacs.5c06325. Journal of the American Chemical Society.(https://doi.org/10.1021/jacs.5c06325) Oxa-Iboga alkaloids lack cardiac risk and disrupt opioid use in animal models. Havel V, Kruegel AC, Bechand B, et al. 2024;15:8118. DOI: 10.1038/s41467-024-51856-y. Nature Communications (https://doi.org/10.1038/s41467-024-51856-y)

Kevin Balktick

Founder + Director

Horizons Media, Inc.

Moderator

Juliana Mercer

Director, Veteran Advocacy and Public Policy, Healing Breakthrough

Healing Breakthrough

The United States has recently emerged as an unlikely policy leader in a decadeslong movement to create regulated access pathways to psychedelics. In a uniquely American way, rather than there being a single, well-defined national framework, several concurrent options have emerged. FDA-regulated medicine, state-regulated supervised experiences, religious use, decriminalization, and of course, unregulated use of many stripes all co-exist alongside one another.

Before hearing from leaders of initiatives across this spectrum, let us think about the uniqueness of this moment in American psychedelic policy and culture, how it compares to the global and historical cornucopia of dynamics between psychedelics and humans.

Kate M. Reynolds, MPH

Director of Research

Rocky Mountain Poison & Drug Safety

Existing national drug surveys often ask only broad questions about psychedelic use or lack the rigor to reliable measure factors important to understanding the real-world implications of psychedelic use. Rocky Mountain Poison & Drug Safety has created the National Survey Investigating Hallucinogenic Trends (NSIHT) to collect detailed, substance-specific data while producing reliable estimates for the United States adult population.

The recent 2025 NSIHT report draws on 52,764 completed surveys, including 3,880 adults who reported psychedelic use in the previous year. It estimated that 5.3% of United States adults—about 13.9 million people—used at least one of 13 psychedelic, hallucinogenic, or dissociative substances in 2025. Psilocybin was the most common, and patterns differed by substance, age, sex, and region.

Using the 2024 and 2025 NSIHT datasets, Kate M. Reynolds, MPH, will present findings on prevalence, reasons, and perceived risks and benefits. The results show why national surveillance must distinguish among substances and track both regulated and unregulated use as laws and patterns of access change.

The most recent (2025) NSIHT report is available here: -https://www.rmpds.org/sites/default/files/2026-09/2025%20NSIHT%20Report_Final%20Report_0.pdf

The bibliography of NSIHT publications is available here: https://www.zotero.org/groups/6619074/nsiht_public_bibliography

Jason Luoma, PhD

Director of Research

Portland Institute for Psychedelic Science

Oregon’s psilocybin program allows adults to receive mushroom-derived psilocybin at licensed service centers under the supervision of licensed facilitators. It differs from clinical trials in important ways: clients do not need a diagnosis or referral, services occur in community settings, and clinical treatment is generally outside the facilitator’s scope.

The Open Psychedelic Evaluation Nexus followed 346 clients at 24 of Oregon’s 26 active service centers, with confidential assessments before their session and at one week, one month, and three months afterward. Four participants, or 1.2%, experienced behavioral reactions requiring medical attention. At one month, 92.2% reported that they had benefited from the experience; at three months, participants reported lower levels of depression, anxiety, and post-traumatic stress symptoms, along with greater mental well-being and life satisfaction.

Jason B. Luoma, PhD, will present these findings and their limits. The longitudinal outcome and safety results come from the 346-person prospective cohort; the paper also compares that cohort with Oregon Health Authority administrative data for all service recipients during the overlapping period to assess representativeness. The study is observational and has no control group, but it offers an early view of real-world safety, outcomes, informed consent, and the need for longer-term monitoring.

References

• Safety and Mental Health Outcomes of Oregon State-Regulated Psilocybin Services. Korthuis PT, Cook RR, Gregoire D, et al. 2026;9(8):e2630608. DOI: 10.1001/jamanetworkopen.2026.30608. JAMA Network Open.
• Oregon Psilocybin Services Data and Reporting. Oregon Health Authority.

Denali Wilson

New Mexico State Director of Strategic Support

Healing Advocacy

Governor Michelle Lujan Grisham signed Senate Bill 219, the Medical Psilocybin Act, on April 7, 2025. The law created a program within the New Mexico Department of Health for qualified patients with treatment-resistant depression, post-traumatic stress disorder, substance use disorders, and end-of-life anxiety or depression.

The law authorizes natural psilocybin in approved settings under clinical supervision, creates a Medical Psilocybin Advisory Board, and establishes separate funds for treatment access and research. It also directs the Department of Health to collect data, evaluate the program, and publish annual assessments.

Denali Wilson, New Mexico State Director of Strategic Support at the Healing Advocacy Fund, will explain the model as the Department develops rules for producers, laboratories, clinicians, approved settings, treatment protocols, and safety. The statute requires implementation by December 31, 2027; the Department’s current public goal is to enroll the first patients by the end of December 2026, with medical use and supervised dosing beginning once the rules and regulations are complete and in effect. The session will examine how New Mexico’s medical framework differs from the broader adult-access systems in Oregon and Colorado.

References

• Medical Psilocybin Act. Senate Bill 219, Chapter 73, signed April 7, 2025. New Mexico Legislature.
• Medical Psilocybin Program. New Mexico Department of Health.
• Medical Psilocybin Program Frequently Asked Questions. New Mexico Department of Health.
• White Paper on Psilocybin. Updated September 3, 2024. New Mexico Department of Health.

Harry Grammer, PhD

Founder

New Earth

Ariana Judith Zepeda, LCSW

Deputy Director

New Earth

What if psychedelic healing could do more than help young people recover from trauma? What if it could expand the boundaries of who they believe they can become? Harry Grammer, PhD, and Ariana Zepeda, LCSW, of New Earth share a powerful journey from the concrete walls of youth incarceration to psychedelic-assisted therapy, the rainforests of Costa Rica and Ecuador, and an emerging vision for a new generation of global service leaders. Drawing from New Earth’s work with formerly incarcerated and at-risk youth ages 13–25, they explore a model where psychedelics open the window, nature becomes the doorway, the world becomes the classroom, and service becomes the purpose. The presentation will introduce New Earth’s developing Community Care Clinic in Los Angeles and the vision for Nueva Tierra in Ecuador to help young people move beyond the boundaries of trauma, neighborhoods, and systems to discover their place, purpose, and capacity to serve in a much larger world.

Maj. Gen. Glenn H. Curtis (Ret.)

Ambassador

Americans for Ibogaine

W. Bryan Hubbard

CEO

Americans for Ibogaine

Martin Tucker

Chief Investment Officer, Choctaw Nation of Oklahoma

Choctaw Nation of Oklahoma

W. Bryan Hubbard, Chief Executive Officer of Americans for Ibogaine, and Maj. Gen. Glenn H. Curtis (Ret.), an Americans for Ibogaine Ambassador and founder of Awaken Warriors, will discuss the coalition forming around the clinical development of ibogaine and related psychedelic medicines in the United States. Their perspectives bring together policy strategy, military and veteran advocacy, tribal leadership, and lived experience.

The session traces recent state legislation and research programs, Executive Order 14401, and the Advanced Research Projects Agency for Health’s ASCENT-IBO initiative. ASCENT-IBO calls for early-stage clinical trials of ibogaine for opioid use disorder and coordination among researchers, clinicians, government, and other partners. The speakers will consider how coalitions can secure public investment, build durable research pathways, and maintain accountability as the evidence base develops.

Ibogaine remains a Schedule I controlled substance and is not approved for medical use in the United States. The conversation will address what responsible progress requires: rigorous trials, appropriate clinical safeguards, community participation, and transparent oversight before broader access is considered.

References

• Ibogaine Legislation: State-by-State Tracker. Americans for Ibogaine.
• Accelerating Medical Treatments for Serious Mental Illness. Executive Order 14401, April 18, 2026. The White House.
• ASCENT-IBO: Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder. Advanced Research Projects Agency for Health.

Michelle Lhooq

Journalist, Rave New World

Rave New World

Moderator

Krista Tippett

Founder, The On Being Project

The On Being Project

Over the last five years, a bipartisan political coalition has accomplished a dazzling streak of cultural and policy victories that seemed impossible as recently as ten years ago.

While united by a desire to increase safe and effective treatment options for serious mental health and neurological disorders, tensions have emerged as communities with dramatically different belief systems and values attempt to collaborate.

What are the unique forces that have held an unlikely coalition together thus far, and can they withstand the energy that may soon be released as idealized dreams convert into complex realities?

Bia Labate, PhD

Executive Director

Chacruna Institute

Dr. Beatriz Caiuby Labate (Bia Labate) is a renowned anthropologist, educator, author, speaker, mentor, and activist deeply committed to the protection of sacred plants and amplifying marginalized voices in the field of psychedelic science. Bia grew up in São Paulo, Brazil and lived there until she was 38 years old. From the age of 10 to 26 she participated in an international youth organization promoting peace and cultural dialogues. Intrepid backpacker and traveler since young age, she always enjoyed learning about other cultures, languages, and traditions, which lead her to study social sciences with a focus on anthropology. She first encountered mushrooms and peyote in 1990, while backpacking Mexico, and ayahuasca in the Amazon in 1996. A queer Brazilian anthropologist based in San Francisco, her academic and professional journey has been profoundly shaped by her experiences with ayahuasca.

Dr. Labate holds a Ph.D. in social anthropology from the University of Campinas (UNICAMP), Brazil. Her research focuses on psychedelic plant medicines, Indigenous shamanism, ceremony, religion, drug policy, and social justice. She is Executive Director of the Chacruna Institute for Psychedelic Plant Medicines, an organization dedicated to promoting reciprocity in the psychedelic community and supporting the protection of sacred plants and cultural traditions. She also serves as Senior Advisor for Culture and Strategy at the Multidisciplinary Association for Psychedelic Studies (MAPS), advocating for public education, harm reduction, and policy reform in the field of psychedelic-assisted therapies.

Paule-Prisca Ognigui Ebe

Gabonese Cultural Advocate, Heritage Preservation Leader & Co-Founder, Y’Azo Communauté

Y’Azo Communauté

Ibogaine, once obscure not only in American popular culture but even within its psychedelic community, has stepped into the limelight.

While much has been made of what ibogaine might do for North Americans and Europeans struggling with addiction, traumatic brain injury, and other serious illnesses, much less attention has been paid to the living communities from which it originates.

The history of the Gabon nation and its relationship with the United States, the many ethnic communities and tribes that inhabit its lands, and the Bwiti religious practices and other traditional uses of tabernanthe iboga, and the day-to-day lives of Gabonese citizens are rich cultural stories that are still very much still being written.

How might the newfound American and global passion for ibogaine affect this already-complex cultural, ecological, and economic landscape, and what are the futures that Gabonese communities hope will emerge from this unexpected historical moment?

Alberto “Nachi” López Pérez

Board Member and Huachuma Conservation Center Director

Colectivo Huachuma

Laurel Sugden

Executive Director

Colectivo Huachuma

Long before mescaline arrived in the Victorian-era avant garde, Andean communities held relationships with Huachuma—also known as San Pedro—that were inseparable from place, ceremony, collective life, and systems of knowledge carried across generations. Those living traditions continue, but are under pressure from tourism, international trade, ecological degradation, and extraction.

Representatives of Colectivo Huachuma will trace the history and present condition of Huachuma in its homeland, and share a message endorsed by all 4 major healers’ associations in Huachuma territory, which together represent more than 300 Maestros Curanderos in northern Peru.

The session asks what stewardship requires when a plant, a landscape, a living healing tradition, and a local economy are all at stake. What philosophies and practices can preserve and strengthen traditional biocultures in a rapidly changing world?

References

• New statements from the Maestros Curanderos of North Peru. July 15, 2026. Huachuma Collective.
• Huachuma Collective: Biocultural conservation in the Andes. Official website. Huachuma Collective.
• The Ark: Biocultural Sustainability for the San Pedro Cactus. December 2, 2024. Laurel Sugden and Josip Orlovac Del Rio.

As the 19th Horizons conference comes to an end, speakers from across its many included disciplines will offer their parting thoughts, hopes, dreams, and questions after three long days of learning, connection, and community.