SECTION 3
The neuroscience regulatory landscape is evolving. In 2024, the FDA approved new drugs for Alzheimer’s disease and schizophrenia and showed flexibility concerning surrogate endpoints. We examine the regulatory risks of developing psychedelics, how to utilize innovative trial designs, and the recent uptick in neuroscience breakthrough designations.
Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Andreas Lysandropoulos, M.D., Ph.D.
SVP, Global Therapeutic Area Head, Neuroscience
Mark Mathieu
Director Publications
Mohit Verma, M.D.
Global TA Section Head, Psychiatry
Mwango Kashoki, M.D., MPH
SVP, Global Head of Regulatory Strategy
Simona Stankeviciute, M.D., MSc
VP, Technical
Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Andreas Lysandropoulos, M.D., Ph.D.
SVP, Global Therapeutic Area Head, Neuroscience
Mark Mathieu
Director Publications
Mohit Verma, M.D.
Global TA Section Head, Psychiatry
Mwango Kashoki, M.D., MPH
SVP, Global Head of Regulatory Strategy
Simona Stankeviciute, M.D., MSc
VP, Technical