The National Institutes of Health announced a $150 million investment to accelerate the development of human-based research methods designed to reduce reliance on animal models, marking the first awards under its Complement Animal Research in Experimentation program.
The initiative focuses on advancing new approach methodologies, or NAMs, which include lab-based and computational systems that more accurately simulate human biology. The goal is to improve the predictive power of disease models while enhancing clinical translation outcomes.
Research teams across the United States will lead projects aimed at building more sophisticated and relevant models of human disease. The program will establish technology development centers to support innovation in areas such as gynecological conditions, cardiac disease, neurological disorders, and rare diseases.
To support collaboration and standardization, the NIH will also launch a centralized data hub and coordinating center, alongside a validation and qualification network developed in partnership with industry and regulatory stakeholders. This network is intended to help bring validated methods to market and ensure regulatory readiness.
As part of the broader effort, the NIH is contributing approximately $20 million toward the validation network, which has already selected pilot projects targeting preterm birth, developmental neurotoxicity, inhalation toxicity, and acute oral toxicity.
Additionally, the program includes a $7 million challenge initiative conducted in partnership with the U.S. Food and Drug Administration and the Environmental Protection Agency. This effort aims to accelerate the real-world application of human-based methodologies within a three-year timeframe.
The funding underscores a strategic shift toward more human-relevant research tools, expanding the scientific toolkit available for studying disease and evaluating treatments, while reducing dependence on traditional animal testing models.
KEY QUOTE:
“This is an exciting opportunity to create a repertoire of human-focused methods that are so sophisticated and comprehensive that successful clinical translation will rise and we will be able to answer questions beyond our reach with current research models. These new projects are key steps in expanding and strengthening our scientific toolbox. NIH’s investment in NAMs is critical to our mission to carry out gold-standard research.”
Nicole Kleinstreuer, Ph.D., Deputy Director for Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health
