Lisa L Smith – Phillips Lytle LLP

Phillips Lytle is a longstanding firm of over 170 attorneys with offices across New York State as well as in Chicago, Washington DC, and Canada.  Lisa co-leads Phillips Lytle’s Psychedelics and Mental Health Therapeutics practice, assisting clients in the psychedelics and ketamine space (including ketamine-assisted psychotherapy) to accomplish their business goals while achieving regulatory compliance and mitigating risk.  Lisa has decades of experience providing guidance to clients in the life science space, from startups to Fortune 100 pharmaceutical companies, on all issues affecting the lifecycle of a medication and its clinical use.  Lisa also counsels investors, entrepreneurs, hospitals, universities, and research institutions, all of whom are also stakeholders.

Lisa has a deep and broad knowledge of the regulatory and legal issues related to the approval, labeling, marketing, and use of medications to treat mental health conditions, having served as national science counsel for a global pharmaceutical company in thousands of cases involving antidepressant medication for nearly two decades.  Her legal experience, as well as her science degree in biology (and the doctorate degrees of her colleagues in pharmacy, chemistry, and physiology), inform the advice she gives, and the value she adds, to clients in the psychedelics space, as well as her effectiveness in communicating scientific, medical and legal issues to achieve her clients’ goals in this emerging industry.  Lisa and her multidisciplinary team have an established track record in counseling companies and investors in entity and venture formation, financing, commercialization, pre- and post-marketing strategies, regulatory approvals, compliance and enforcement, IRB protocols, pharmacovigilance, and licensing.  Lisa has written and spoken on key issues impacting psychedelics, including federal and state statutory and regulatory mandates, diversity in clinical trials, DEI considerations regarding psychedelic therapy, and novel issues of informed consent. Lisa is also co-chairing the New York State Bar Association Health Law Section’s new Psychedelics subcommittee, and consistent with her leadership roles on health issues, she was recently appointed to the New York State Bar Association’s Presidential Task Force on Opioid Addiction.

Publications

• Federal Agencies Discuss Steps to Advance PTSD Treatments, Including Psychedelics
• A Recent FDA-Sponsored Meeting Addressed Psychedelic Drug Development, Including the Limits of FDA’s Regulatory Authority
• FDA Breakthrough Therapy Designation for LSD Formulation
• Progress for Research Funding on Psychedelics for Military Personnel and Veterans/First Responders

Speaking Engagements

• Presenter, Mocktails, Mushrooms & Marijuana: Bringing the Cannabis Conversation to a Higher Consciousness, Nootropic Night, May 2024
• Presenter, Evolving Regulatory Landscape for Psychedelic Medications, New York Life Sciences Innovation Showcase/Investor Event, MedTech, June 2023