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Andreas Lysandropoulos, M.D., Ph.D.

Franchise Head, Neurosciences, Ophthalmology, and Rare Diseases

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NEW MEDICINES, NOVEL INSIGHTS

Accelerating the new frontiers in neuroscience

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.

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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.

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IN THIS REPORT

Patient-guided development

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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 Accelerating clinical development

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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 Regulatory strategies that work

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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 Evidence & Market Access

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.

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