Accelerating patient access to psychedelic-assisted psychotherapy
Psychedelic science is at an important juncture. Recently conducted double-blind, randomised controlled trials in highly supported clinical settings among well-defined patient populations with high unmet needs provide evidence of large effect sizes with durable results. At the same time, it is a rich period of regulatory innovation with different regulatory options in Europe and the US that may be used to accelerate patient access to valuable treatments. Translating academic research into effective mental health care pathways requires early engagement of regulators, health technology assessors payers and patients to ensure this next phase of research leads to patient care. Approaches for achieving this will be shared, compared and discussed at this presentation. This session is most suited for clinical researchers who wish to design studies with the greatest likelihood of contributing to regulatory approval, health system utilisation and reimbursement.
George Goldsmith is a co-founder and director of COMPASS – a non-profit medical research organisation dedicated to accelerating access to evidence-led innovation in mental health and wellbeing. George’s early training and experience was a blend of cognitive psychology, clinical psychology and computer science. A serial entrepreneur, he has developed pioneering businesses in collaboration software and professional services. He has served as the Managing Director of the Lotus Institute and as CEO of TomorrowLab at McKinsey & Company. As chairman and founder of Tapestry Networks he has worked with medicines regulators, payers, patient groups, pharmaceutical companies, and researchers in Europe and the US to accelerate drug development and improve cost-effective patient outcomes. George enjoys working with teams seeking to do extraordinary things – creating environments where people suspend disbelief, build trust and pursue unlikely combinations of new ideas and technologies to improve the lives of others.