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.
Senior Vice President, Global Therapeutic Area Head, Neuroscience
Mark Mathieu
Executive Director, Strategic Research
Mohit Verma, M.D.
Global Section Head, Psychiatry
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Simona Stankeviciute, M.D., M.Sc.
Vice President, Technical
Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Andreas Lysandropoulos, M.D., Ph.D.
Senior Vice President, Global Therapeutic Area Head, Neuroscience
Mark Mathieu
Executive Director, Strategic Research
Mohit Verma, M.D.
Global Section Head, Psychiatry
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Simona Stankeviciute, M.D., M.Sc.
Vice President, Technical
Stay current with novel thinking and actionable insights from our experts.
At Parexel, we advise sponsors on strategies to accelerate development timelines and effective ways to support approval and access to new neuroscience treatments. Sponsors can take calculated risks in this fast-evolving scientific and regulatory environment, such as utilizing novel biomarkers and endpoints, innovative trial designs, patient-guided feasibility testing, a bespoke regulatory strategy, and real-world evidence. We help them mitigate risks with expertise gained from experience.
In the past five years, our neuroscience-focused team of patient advocates, clinicians, scientists, statisticians, and former regulators has partnered with sponsors for more than 600 clinical and consulting projects, enrolling 47,000 patients.