Microdosing (Part 3): The path to FDA approval with Diamond Therapeutics and MindMed
Business Trip, a podcast about psychedelic entrepreneurship
Welcome back to Business Trip, a podcast about psychedelic entrepreneurship! 🍄
This is final episode in our 3-part series on microdosing that explores the science, history, and clinical applications.
In this episode, we wanted to understand how companies are designing their FDA clinical trials for microdosing. Most importantly, what will it take to get FDA approval? We chat with the chief medical officers of Diamond Therapeutics and MindMed about their clinical programs. Diamond's program uses synthetic psilocybin and is focused on anxiety disorders. Meanwhile, MindMed is using low doses of LSD to treat adult ADHD. Our guests are Dr. Mike McDonnell (Diamond Therapeutics) and Dr. Dan Karlin (MindMed).
In this episode, we discuss:
Overview of ADHD, anxiety disorders, and how microdosing may treat them
The designs for their FDA clinical trials
The decision between using psilocybin vs. LSD
In case you missed it: In Part 1, we interviewed psychedelic researcher James Fadiman about the fundamentals of microdosing. In Part 2, we discussed placebo effect and the results of a self-blinded placebo-controlled study with Balázs Szigeti from the Centre for Psychedelic Research at Imperial College London.
Disclaimer: This is not investment advice and is for information and educational purposes only.
Business Trip tells the story of the emerging industry of psychedelics. Each episode features a new company in the field, ranging from biotech startups developing novel compounds, to clinics and retreats for healing, to software companies building tools to power the ecosystem.
Business Trip is produced by Greg Kubin and Matias Serebrinsky — we’re partners at PsyMed Ventures, advocates of the healing powers of psychedelic medicine and see a bright future ahead for the industry.
Thanks for listening,
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