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 also 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.

Publications

• FDA Issues First Draft Guidance on Clinical Trials for Psychedelic Drug Developers
• FDA Issues Draft Guidance on Diversity and Inclusion in Clinical Trials
• Psychedelic-Assisted Therapy – First Professional Practice Guidelines

Speaking Engagements

• Lisa L. Smith presented at the New York Life Sciences Innovation Showcase/Investor Event on the evolving regulatory landscape for psychedelic medications and what the near-term future holds for investors. The event, hosted by MedTech, was an opportunity for attendees to connect with cutting edge bio/med startups from across New York’s innovation ecosphere.