Broadcast Date: Thursday, March 02, 2023
from 3:00 pm to 4:30 pm (ET)

Overview:

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 issues that will be covered in this course are:

  • 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?

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-Demand Webcast

 

Prerequisite:

General knowledge of psychedelic therapy

 

Course Code:

1410687

 

NY Category of CLE Credit:

Areas of Professional Practice

 

Total Credits:

1.5 CLE

Speaker Panel:

Karl P. Frederic, Partner
Head of Cannabis and Alternative Therapies Practice Group

Windels Marx Lane & Mittendorf, LLP

Karl Frederic is a Partner in the law firm of Windels Marx Lane & Mittendorf, LLP. He conducts a multi-disciplinary practice focusing on real estate and business transactions in the pharmaceutical, healthcare and biotech industries. Over the course of his 30+ year career, he has been the lead counsel on innumerable projects requiring specialized expertise, including  the establishment of a new medical school on a former pharmaceutical research and development campus, the refit of a production facility to manufacture immunotherapy products to treat leukemia and the development of a laboratory and pilot plant for a biofabrication process to make leather without animals. In recent years, as cannabis and psychedelic therapies have reached the mainstream, his experience in these traditional areas has naturally broadened his focus to service clients in those emerging markets.

Michael E. Cindrich, Founder and Principal Attorney
Top Cannabis Business Attorney

Law Offices of Michael E. Cindrich, APC

Michael E. Cindrich is a graduate of the University of San Diego School of Law and a California attorney with over fifteen years’ experience in criminal and civil litigation, including the litigation and trial of dozens of misdemeanor and felony cases while a Prosecutor for the San Diego District Attorney’s Office. Mr. Cindrich is best known for being a fierce litigator and one of the top cannabis attorneys in California. He has successfully won “Not Guilty” verdicts on several high profile cases, and had dozens of cases dismissed for lack of evidence, illegal search and seizure, and in the interest of justice. Mr. Cindrich successfully argued illegal search and seizures by law enforcement resulting in multiple felony cases being dismissed during the pretrial phase.  Mr. Cindrich has also advised and consulted with thousands of entrepreneurs in numerous aspects of business law and regulatory compliance in the cannabis industry.

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

Spaulding Financial LLC

Co-Founder and Managing Member, Erin Spaulding, CVA, CM&AA has over 20 years of experience involved in all forms of valuations and has provided various financial consulting services to numerous organizations in her time with Spaulding Financial, SingerLewak, PriceWaterhouseCoopers, American Appraisal Associates and GurseySchneider.

As an expert, Erin has served attorneys and corporate clients in shareholder disputes, and lost profits and economic damages cases with valuation and economic modeling capabilities. She has also spoken on professional panels in the areas of cannabis and technology, corporate transactions related to private equity, venture capital, angel-backed and independent sponsored deals.

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

Date & Time:

Thursday, March 02, 2023

3:00 pm to 4:30 pm (ET)

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
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SPEAKERS

Karl P. FredericPartner
Head of Cannabis and Alternative Therapies Practice Group
Windels Marx Lane & Mittendorf, LLP
Michael E. CindrichFounder and Principal Attorney
Top Cannabis Business Attorney
Law Offices of Michael E. Cindrich, APC
Erin Spaulding, CVA, CM&AACo-Founder and Managing Member
Valuation Expert in Cannabis, Psychedelics, and Other Sectors
Spaulding Financial LLC

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