2022 Conference Agenda

Day Two - May 24, 2022

7:55 am

Chairperson's Opening Remarks

Varun Renjen, MD, Managing Director, Life Sciences Strategy KPMG

8:00 am

What Will it Take for Big Pharma to Enter the Psychedelic Space

As pharma looks to enter the psychedelic space, key questions and challenges remain around the commercial model required for success. Specifically, questions remain about the go to market model, IP, pricing, reimbursement, market development and dosing. Additionally, as companies looks to expand into new indications outside of classic disorders such as MDD and PTSD, how does the model continue to evolve? As these key questions and challenges are solved for, big pharma interest in the space will continue to grow.
Varun Renjen, MD, Managing Director, Life Science Strategy, KPMG

8:30 am

Psychedelics in Psychiatry: State of the Union

In this presentation Mr. Trucchio will cover the following:
  • An overview of leading next generation neuropsychiatry companies and psychedelic-based compounds in clinical development
  • A Review of clinical data generated to-date
  • Shine a spotlight on the next clinical trial data readouts that could impact the space
  • And conclude with view of valuations and where we go from here
Patrick Trucchio, Managing Director, Biotechnology Analyst, H.C. Wainwright & Co.
9:00 am

So You Want To Get A Psychedelics License In Oregon

On January 2, 2023, Oregon will begin accepting applications for licensing psilocybin businesses, including psilocybin service centers and manufacturing operations. Join us for a conversation about what people can do to plan and prepare to apply for Oregon psilocybin business licensure.
Jeff Zuber, Founding Partner, Zuber Lawler
9:30 am

The Case for Elucidating the Mechanisms Underlying Therapeutic Effects of Psychedelic Compounds

In this presentation Dr. Gage will highlight the multiple pharmacologic targets of psychedelic compounds. She will review the hurdles for scalability of psychedelics as therapeutics and provide an overview of the known unknowns with this novel category of potential therapeutics, including whether the psychedelic experience is needed for the therapeutic effect. She will also discuss the need for biomarkers to accelerate the clinical development of these compounds. She will then discuss the need for:

  • Biomarkers of therapeutic effect for trial endpoints and for demonstration of clinical effect
  • Biomarkers identifying patient sub-populations with a pathophysiology that would be targeted by a specific compound
  • Biomarkers predictive of treatment response
  • Biomarkers predictive of a safety concern

Lastly she will highlight how these biomarkers will both accelerate the development of existing compounds for therapeutic use and the discovery of new compounds with the potential to separate therapeutic effects from psychedelic and other safety concerns.
Allyson Gage, Ph.D., Chief Medical Officer, Cohen Veterans Bioscience

10:00 am

Morning Break

Visit the scientific poster session, network with colleagues over coffee and snacks, visit with our exhibitors and meet new people via our meeting scheduling solution.

10:25 am

PANEL SESSION: Psychedelic Drugs in the Post-Approval World: Important Components of Risk Evaluation and Mitigation Strategy (REMS) Programs to Protect Public Health While Ensuring Widespread Access

Following a presentation of the results from a 2021 survey of key stakeholders which elicited expert opinions on best practices and metrics to assess the safety of psychedelic drugs within the context of a REMS, as well as the most effective structure for such programs (e.g., individual vs. single-shared REMS programs), panelists in this session will discuss the most relevant aspects for designing appropriate REMS programs for this new class of medicines.
PRESENTER: Marion Coe, Ph.D., Director Clinical Development & Postmarketing Surveillance, Pinney Associates
MODERATOR: Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates
Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation
Janetta Iwanicki, MD, Chief Scientific Officer, Research and Consulting, Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority
Sidney Schnoll, M.D., Ph.D., Vice President, Pharmaceutical Risk Management, Pinney Associates

11:15 am

Effective and Efficient Conduct of Registration Trials in Psychedelics

This presentation will outline operational conduct and logistics involved in the successful execution of large global trials with psychedelics in psychiatric indications. Operational considerations including enrolling the right patient population, practically managing placebo response as well as set and setting and ensuring proper safety monitoring will be discussed. Success factors related to controlled drug requirements, regulatory considerations, country and site selection, therapist training, and managing efficacy assessments will also be described as a way to share insights on effective and efficient trial execution.
Christine Moore, Ph.D.
, Vice President, Neuroscience, Scientific Solutions, Worldwide Clinical Trials
11:45 am

Navigating the Regulatory Environment for Naturally Derived Psychedelic Therapeutic Products in the US and Canada

Complex chemistries and inherent modulatory effects have always made developing natural products for use in scheduled conditions challenging. Given additional regulatory restrictions around controlled substances, natural plant and fungal psychedelic products present even greater complexities. In this presentation, Sharan Sidhu of Numinus will discuss solutions and new approaches to address these challenges and develop safe and effective natural therapeutic products that are accepted by the FDA and Health Canada.
Sharan Sidhu, Science Officer & General Manager, Numinus
12:15 pm

Lunch Break

We have numerous options for your lunch experience. Join colleagues in our dedicated lunch space, eat in the restaurant, eat outside on the restaurant patio, or take a box lunch and retire to your guest room for some quiet time.

1:15 pm

PANEL SESSION: The Investor Outlook on the Growing Psychedelics Industry

In this hour session, panelists will discuss the state of the psychedelics industry, including the opportunities and challenges facing psychedelics companies. They will also discuss what investors are looking for from these companies before they will invest.
Henri Sant-Cassia
, Founding Partner, The Conscious Fund

Cody Shandraw, Partner, Ambria Capital
Justin Hanka, Co-Founder, MindBio Therapeutics, Director, Capital Markets, Shape Capital
Larry Schnurmacher, Managing Partner, Phyto Partners
2:15 pm

PANEL SESSION: Navigating Complex Regulatory Requirements for Researching Psychedelic Drugs: FDA and DEA Considerations

Seth Mailhot of Husch Blackwell’s FDA team, and Natasha Sumner, Karen Luong and Kim Chew the firm’s psychedelic therapeutics team will discuss the federal regulatory requirements for developing and researching Schedule 1 psychedelic drugs in the United States, and provide a roadmap for applicants seeking to obtain the licenses needed for this research.This discussion will cover application procedures and requirements for DEA Schedule 1 licenses, license renewals, and licenses in multiple locations/states. The panel will also present an overview of the FDA’s framework for drug development, including IND (Investigational New Drug) applications and “fast track” procedures.

Karen Luong, JD, Senior Counsel, Husch Blackwell
Seth Mailhot, JD, Partner, Husch Blackwell
Natasha Sumner, JD, Senior Counsel, Husch Blackwell
Kimberly Chew, JD, Senior Counsel, Husch Blackwell

3:00 pm

End of Conference

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