In this webinar the following topics will be covered:
• Regulatory requirements for developing a CNS-active drug and how they apply to psychedelics
• Importance of abuse potential evaluation and the drug scheduling process
• Required preclinical and clinical studies and timelines
• Strategies for early data collection to inform abuse potential, safety, and proof of concept (efficacy)
• Intricacies of handling a Schedule I substance in drug trials
Dr Beatrice Setnik, Chief Scientific Officer at 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 at 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 the USA. In 2001 Sharon became a Director and co-founder of RenaSci Limited until it was acquired by Sygnature Discovery in 2018.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: [ Ссылка ]
54:12 — Q&A
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