Taking the Bad Trip Out of Psychedelic Medicines: Investing in An Emerging New Paradigm in Therapeutics

March 15, 2023 11:00am

Kimberly I. Chew
Partner
Husch Blackwell LLP

Dr. Berra Yazar-Klonsinski
Chief Scientific Officer
MAPS Public Benefit Corporation

Psychedelics are increasingly making headlines, especially for the treatment of mental illnesses such as PTSD. Exciting new drug applications involving MDMA, DMT, and psilocybin are making their way through clinical trials and the political and public policy cadence continues to shift towards recognizing the medical value of psychedelics; the DEA is also looking to dramatically boost the production quotas of certain psychedelics, including LSD, psilocyn and mescaline.

  • Which psychedelics are closest to FDA approval and which remain on the fringes?
  • Navigating the difficulty of securing psychedelics for research in order to demonstrate its medical value
    • Best practices for applying for a DEA research license
    • Partnering with universities and research institutions
  • Best practices for comprehensive IND and NDA applications
  • Reviewing the other pathways including Special Protocol Assessment, Breakthrough Therapies, Fast Track and Priority Review
    • Discovering a new way forward: REMS patents?
  • Lessons learned from the failed petitions to reschedule psychedelics
    • An update on the challenge to DEA’s rescheduling petition denial (Right to Try) in the U.S. Court of Appeal’s 9th circuit.