USP joins FNIH Biomarkers Consortium to advance biomarker standardization

The Consortium's four steering committees each focus on a prevalent disease or condition.

Rockville, MD, October 02, 2025 - The United States Pharmacopeial Convention (USP) has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, effective as of August 2025. USP will participate in the Consortium's four steering committees, each focused on a different medical condition: 1) Cancer, 2) Inflammation and Immunity, 3) Metabolic Disorders, and 4) Neuroscience.

The Biomarkers Consortium is a public-private research partnership that works to discover, develop, and seek regulatory acceptance of solutions (e.g., disease biomarkers and surrogate endpoints) to support new drug development. By joining the Consortium, USP will contribute its expertise in areas like assay development and validation, as well as standards-setting. Collaboration will also help inform the biomarker standards that USP develops, which aim to improve the consistency of biomarker measurement across multiple assay platforms and suppliers.

"We are committed to leverage our expertise and advance standardization of testing approaches for biomarkers. This partnership will aid USP's understanding and exposure to biomarker development across highly prevalent disease areas," said Fouad Atouf, PhD, USP Chief Science Officer. "This knowledge-sharing can inform strategy for future biomarker standards, including new physical reference standards or materials and documentary standards. It also enables USP to expand its support for quality and consistency of medicines throughout the product lifecycle."

Biomarkers are biological signals that provide evidence of a medical condition, disease, or other abnormal biological processes. A biomarker may be used to observe how well the body responds to a given medical treatment, helping to assess patient samples during clinical trials for new drug candidates.

The Foundation for the National Institutes of Health builds public-private partnerships that connect biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health; and helps train the next generations of scientists. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.

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