Nearly ten years after the FDA first granted Breakthrough Therapy Designation to a psychedelic therapy program, where does the field of psychedelic medicine actually stand?

In this opening session, we will take a step back from the latest news to examine the state of industry, including the essential economic facts and trends, the composition of the ecosystem, and the essential questions facing its future.

After decades of research and advocacy, federal regulators and elected officials seem ready to allow psychedelic drugs and treatments to enter the American healthcare system.

This breakthrough requires a series of decisions by several government agencies, including those within the Department of Health and Human Services and the Department of Justice — which are now compelled to prioritize this work by an Executive Order. In addition to Executive action, Congress may have an opportunity to expedite this process with supportive legislation.

In this session, federal policymakers will share how they believe the federal government might implement safe and effective access to psychedelic medicines.

Where will the nascent psychedelic industry find funding for the next round of trials, and should they succeed, the infrastructure to commercialize drugs and deliver care?

Following an era of exuberance fueled by retail investors, ZIRP, and headline news in 2020 and 2021, financing for psychedelic concerns entered a period of malaise that is only now beginning to reverse.

Nonetheless, several sponsors have emerged from these lean years with promising candidates. As these companies move through Phase 3 trials and seek approval, the magnitude and nature of funding (and funders) has changed dramatically.

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

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 fields. 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 economic viability of the entire field.

With numerous promising candidates having completed or in the midst of Phase 3 trials, FDA approval for psychedelic medicine is — once again — widely anticipated.

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.

Join leading experts in commercialization as they address the hydra of essential questions for the day after approval, including federal and state regulatory, REMS and pharmacy, reimbursement, workforce development, clinic preparedness and capacity, and public relations.

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

What has been learned from the proliferation of pre-approval training programs and research sites? How prepared is the industry for the day when theory meets practice in a post-approval world?

Join us as we hear what early leaders in training, education, and clinical operations believe will be needed to deliver safe, effective care at scale while staying in the black.