The U.S. Food and Drug Administration (FDA) has started a cross-center program to coordinate neuroscience product development, beginning with work on how to evaluate products intended to prevent or delay Alzheimer’s disease.
The Neuroscience Advancement and Innovation Nexus (NAIN) will use expertise from the FDA’s drug, biologics and device centers to consider issues that cut across product types. Those centers include the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. The agency said NAIN is intended to strengthen scientific tools and regulatory methods for products aimed at conditions affecting the brain and nervous system. The program’s remit spans neurological and psychiatric conditions, substance use disorders and pain. Alzheimer’s is the program’s first focus within that wider remit.
NAIN’s first project, the Alzheimer’s Prevention Accelerator, will explore clinical-trial approaches for prevention and early-intervention drug development. The FDA said the work will look at which populations to include in trials, which endpoints fit different stages of disease, and what evidence can show that a product prevents or delays cognitive decline. Patients and caregivers, researchers, industry, academia, public-private partnerships and other government agencies are among the groups the FDA said it will engage.
The FDA cited limited understanding of disease biology, differences in how conditions present and the long timelines of some illnesses as obstacles to proving meaningful clinical benefit. It pointed to biomarkers, digital health technologies and other product-development tools as possible ways to address those challenges.
Acting FDA Commissioner Kyle Diamantas, J.D., said NAIN is intended to keep regulatory science and cooperation among FDA centers aligned with advances in neuroscience. The FDA said the program will pair its scientific and regulatory expertise with engagement from the research community and federal partners. NAIN and its Alzheimer’s initiative both support the National Alzheimer’s Project Act, the federal framework for coordinated action on Alzheimer’s disease and related dementias.
