NEW MEDICINES, NOVEL INSIGHTS
Neuroscience is nearing a tipping point, poised for unstoppable scientific, clinical, and commercial acceleration. Three trends got us here: scientific advances that could enable disease-modifying therapies, the increasing burdens of neurologic, psychiatric, and addictive illnesses, and recent clinical trial results and drug approvals that suggest a more flexible regulatory approach. This report explores how neuroscience developers can advance with courage and urgency while mitigating risks.
FEATURED EDITORIAL
We can accelerate neuroscience research with courage and urgency
By Andreas Lysandropoulos, M.D., Ph.D., Senior Vice President, Global Therapeutic Area Head, Neuroscience
We are at a tipping point in neuroscience research, much like cardiology and oncology were decades ago. At a tipping point, progress becomes unstoppable, but we are not there yet. We must collaborate with an urgency that matches these diseases' immense burden on individuals and society.
IN THIS REPORT
SECTION 1
Patient-guided development
Trials in neuroscience are more burdensome and last longer than in other therapeutic areas, slowing the development of critical new therapies. We describe a pioneering approach to reinvigorate the Alzheimer’s disease clinical research infrastructure for early-stage trials and offer practical advice for engaging and enrolling diverse patient populations.
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SECTION 2
Accelerating clinical development
Assessing the feasibility of a study’s design before it starts can mitigate many of the risks unique to neuroscience trials. We work with sponsors to deploy precision techniques in developing psychiatric and neurological treatments. It’s a nascent effort, but we see progress. Digital biomarkers could boost development efficiency and commercial viability for sponsors developing neuroscience treatments.
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SECTION 3
Regulatory strategies that work
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.
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SECTION 4
Evidence & Market Access
Neurological and psychiatric disorders are leading causes of ill health, disability, and premature death globally, but they progress slowly. Demonstrating value to payers who prefer near-term effects on symptoms is challenging. We discuss why access strategies should start early, engage patients, and use novel biomarkers and real-world evidence.
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Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Andreas Lysandropoulos, M.D., Ph.D.
Franchise Head, Neurosciences, Ophthalmology, and Rare Diseases
Anita Mardian
Vice President and Unit Head, Los Angeles Early Phase Clinical Unit
Jaime-Louise Roberts
Feasibility Strategy Associate Director - Neuroscience and Psychiatry Strategic Team Lead
Jessica Sheldon
Senior Feasibility and Strategy Leader
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Lev Gertsik
Medical Director, Clinical Trials Medical Group, Los Angeles Early Phase Clinical Unit
Lydia Morris
Clinical Research Psychologist
Mark Mathieu
Executive Director, Strategic Research
Mohit Verma, M.D.
Therapeutic Area Lead, 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
Xoli Belgrave
Executive Director, Drug Development Services
Naomi Suminski
Senior Advisor and COA Expert
Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Andreas Lysandropoulos, M.D., Ph.D.
Franchise Head, Neurosciences, Ophthalmology, and Rare Diseases
Anita Mardian
Vice President and Unit Head, Los Angeles Early Phase Clinical Unit
Jaime-Louise Roberts
Feasibility Strategy Associate Director - Neuroscience and Psychiatry Strategic Team Lead
Jessica Sheldon
Senior Feasibility and Strategy Leader
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Lev Gertsik
Medical Director, Clinical Trials Medical Group, Los Angeles Early Phase Clinical Unit
Lydia Morris
Clinical Research Psychologist
Mark Mathieu
Executive Director, Strategic Research
Mohit Verma, M.D.
Therapeutic Area Lead, 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
Xoli Belgrave
Executive Director, Drug Development Services
Naomi Suminski
Senior Advisor and COA Expert
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Learn more about how Parexel is accelerating neuroscience
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.