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Karl P. Frederic
Partner | Windels Marx Lane & Mittendorf, LLP
Michael E. Cindrich
Founder and Principal Attorney | Law Offices of Michael E. Cindrich, APC
Erin Spaulding, CVA, CM&AA
Co-Founder and Managing Member | Spaulding Financial LLC

The Highs and Lows of Psychedelic Therapy: Navigating Legal Complexities | On-Demand Webinar

Broadcast Date: Wednesday, March 2, 2023 | 3:00 PM to 4:30 PM (ET)

In recent years, psychedelics have been gaining popularity when it comes to treating an array of mental health issues. With its promising medical and therapeutic benefits, psychedelic-assisted psychotherapy (PAP) is generating significant interest among policymakers, medical professionals, and the public. As it provides an alternative treatment for refractory mental health concerns, several cities in the U.S are starting to decriminalize some psychedelics.

However, the Food and Drug Administration’s (FDA) approval for psychedelic treatment is still tough. As legal challenges and the upswing of studies in this field are likely to emerge, companies and practitioners must stay in the loop.

In a LIVE Webcast, a panel of key thought leaders and practitioners will offer an in-depth discussion of psychedelic-assisted therapy. Speakers will also dig deep into its potential opportunities, risks and pitfalls, and legal developments.

Key Topics:

  • Psychedelic Therapy: Nuts and Bolts
  • Potential Opportunities of Psychedelics
  • New Shifts in Psychedelic Drug Policies in the U.S.
  • Emerging Legal Challenges
  • What Lies Ahead?

Agenda:

Karl P. Frederic, Partner
Head of Cannabis and Alternative Therapies Practice Group
Windels Marx Lane & Mittendorf, LLP

Michael E. Cindrich, Founder and Principal Attorney
Top Cannabis Business Attorney
Law Offices of Michael E. Cindrich, APC

Erin Spaulding, CVA, CM&AA, Co-Founder and Managing Member
Valuation Expert in Cannabis, Psychedelics, and Other Sectors
Spaulding Financial LLC

1. Introduction

2. Background

  • The Plant-Based Medicine Movement: Cannabis and Psilocybin are adjacent but not the same. Cannabis will be distributed and regulated at retail like alcohol. Generally, psilocybin and other psychedelic remedies will be administered in a clinical setting.
  • Brief History

3. The Legal Landscape

  • Legal But Regulated: Ketamine for off label use, Psilocybin and MDMA getting breakthrough therapy designations from FDA
  • Religious Rituals: Ayahuasca and the use of Peyote in the Native American Church
  • Religious and Tribal Rights
    • Medicinal & recreational use in exempt jurisdictions
    • Sacraments in religious use
  • Schedule I under the CSA

4. The Policy Landscape: State and Municipal Approaches to Psychedelic Regulation

  • Full legalization
  • Legalization
  • Making it a low law enforcement priority

5. What Lies Ahead

  • Legal Challenges
  • Business opportunities:
    • Offshore retreats and clinics
    • Cannabis market comparisons
    • Market for psychedelics – medical and recreational
      • Antidepressants, anti-anxiety, etc.
      • Microdosing
    • Biotech & Pharma life cycle
      • R&D / IP / M&A
    • Marketing regulations
    • Tax implications

Who Should Attend:

  • Health Care Lawyers
  • FDA Law Attorneys
  • General Counsel
  • Clinical Development Professionals
  • Healthcare Services Providers
  • Licensing Professionals
  • Medical Directors
  • Mental Health Counsellors
  • Risk Managers

Register for this course by clicking the “Take this Course” at the top of the page.

CLE Credit:

Course Level: Intermediate | Advance Preparation: Print and review course materials

Method of Presentation: On-Demand Webinar | Prerequisite: General knowledge of psychedelic therapy

Course Code: 1410687 | Total Credits: 1.5 CLE