Welcome back to The Trip Report Podcast, a production of Beckley Waves.

Today, I am speaking with Hailey Gilmore, the former Medical Science Liason at MAPS PBC, Lykos Therapeutics, and founder of Luminous Research Consulting

Hailey joined MAPS in 2020, where she spearheaded their investigator-initiated trials (IIT) program, overseeing how MDMA-assisted therapy could address diverse clinical indications. Her role involved navigating complex regulatory landscapes, establishing protocols, and engaging with researchers worldwide.

Today, as the founder of Luminous Research she leverages her expertise to guide organizations in bringing psychedelics and other innovative therapies to market.

Hailey is a public health scientist with a master’s degree in epidemiology and biostatistics from UC Berkeley. She has spent over 15 years in clinical trial management, initially in the HIV prevention field, where she contributed to groundbreaking studies such as the efficacy of pre-exposure prophylaxis (PrEP) in preventing HIV transmission.

This conversation is a masterclass in understanding psychedelic therapy development's nuanced challenges and opportunities.

Here’s what we cover:

* The Landscape of Psychedelic Therapy: Hailey breaks down the logistical hurdles of bringing MDMA-assisted therapy to market, from FDA approvals to state-by-state legislative processes and the complex interplay of insurance, healthcare institutions, and drug rescheduling.

* Insights from HIV Research: Drawing parallels with PrEP’s rollout, Hailey provides a framework for how psychedelics might navigate similar adoption barriers, including clinician training, insurance buy-in, and the balancing act between small, agile clinics and large academic centers.

* The Role of Smaller Clinics vs. Academic Institutions: She reflects on how smaller clinics might be better positioned to implement MDMA-assisted therapy quickly, given their flexibility, while larger institutions struggle to turn their metaphorical cruise ships.

* Systemic Challenges in the Psychedelic Field: From the intricacies of DEA licensing to the limitations of current research funding, Hailey outlines the systemic barriers that continue to slow progress in this field.

* Optimism Amid Complexity: Despite the delays in MDMA-assisted therapy’s approval, Hailey believes that public-private partnerships and innovative trial designs could unlock new opportunities for psychedelic research and implementation.

Finally, we explore the potential impact of Robert F. Kennedy Jr.'s potential appointment as Secretary of Health and Human Services in the Trump administration. Could this mark a turning point for federal policy on psychedelics? Hailey weighs the possibilities and shares her vision for how public health could guide this evolving conversation.

And now, I bring you my conversation with Hailey Gilmore.

Listen to the episode on Substack, Spotify, Google or Apple.

Credits:

* Hosted by Zach Haigney

* Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari

* Find us at thetripreport.com

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Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary