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 (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.

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.

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.

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.

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.

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.

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 170 participating faculty members from 45 universities across 30 US states.

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 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.