2022 Conference Agenda
Day Two - May 24, 2022
Chairperson's Opening Remarks
Varun Renjen, MD, Managing Director, Life Sciences Strategy KPMG
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
Psychedelics in Psychiatry: State of the Union
- 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
So You Want To Get A Psychedelics License In Oregon
Jeff Zuber, Founding Partner, Zuber Lawler
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
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.
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
Effective and Efficient Conduct of Registration Trials in Psychedelics
Christine Moore, Ph.D., Vice President, Neuroscience, Scientific Solutions, Worldwide Clinical Trials
Navigating the Regulatory Environment for Naturally Derived Psychedelic Therapeutic Products in the US and Canada
Sharan Sidhu, Science Officer & General Manager, Numinus
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.
PANEL SESSION: The Investor Outlook on the Growing Psychedelics Industry
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
The Natural Advantage: A Novel Approach to Approval
Benjamin Lightburn, CEO & Co-Founder, Filament Health
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