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Live Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry - A Roadmap to Studying Safety, Abuse Potential, and Efficacy
There are a number of psychiatric disorders with high unmet clinical need where psychedelics are increasingly being looked to as a potential therapy. Psychedelics have established human abuse potential, and many are Schedule I Controlled Drugs (CDs), i.e. not approved for medical use. Therefore the production, distribution and supply is tightly controlled and regulated. Supporting regulatory approvals for medical use requires safety and efficacy evaluations. For psychedelics in development, regulatory approval will require a shift from Schedule I CD, to a CD schedule for medical use. In this webinar we will discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs. Data for the various types of psychedelics in pre-clinical drug-discrimination, intravenous self-administration and physical dependence models will be presented. We will review the regulatory guidance and offer advice on how these studies can be designed to meet the expectations of FDA, and other regulatory agencies. We will also review safety studies and early examinations of efficacy that can help guide drug development decisions for later phase patient trials.

May 20, 2021 04:00 PM in London

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Speakers

Dr Beatrice Setnik
Chief Scientific Officer @Altasciences
Beatrice has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. She is currently the Chief Scientific Officer at Altasciences and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Beatrice earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. She has published numerous research articles in internationally recognized peer-reviewed journals and is a recognized expert in the field of human abuse and physical dependence potential evaluation.
Dr Sharon Cheetham
Director, In vivo Pharmacology @Sygnature Discovery
Sharon is a Director of In Vivo Pharmacology at Sygnature Discovery. She is a visiting Professor at the University of Nottingham, an external examiner at the University of Bath and a Fellow of the British Pharmacological Society. Sharon started her scientific career at the Institute of Psychiatry, University of London, working in the field of epilepsy with Professor Brian Meldrum. She went on to St George’s Hospital Medical School to study ‘Neurotransmitters and their receptors in post-mortem brain from depressed suicide victims’ with Professor Roger Horton. Sharon transitioned from academia to industry by joining the CNS group at Boots Pharmaceuticals in 1988, which became BASF Pharma, where she headed a team investigating CNS approaches to treat obesity, and was involved in the registration of sibutramine in Europe and USA. In 2001 Sharon became a Director and cofounder of RenaSci Limited, until it was acquired by Sygnature Discovery in 2018.