NIH Launches Initiative to Prioritize Human-Based Research Technologies

The National Institutes of Health (NIH) has launched a new initiative to expand the use of human-based research technologies while reducing reliance on animal models, establishing a dedicated Office of Research Innovation, Validation, and Application (ORIVA) to coordinate these efforts across its biomedical portfolio. 

The initiative aims to scale non-animal methods—organoids, tissue chips, computational models, and real-world data analysis—while increasing funding, training, and infrastructure to support their widespread adoption.

This move closely follows a related policy shift by the U.S. Food and Drug Administration (FDA), announced on April 10, 2025, which outlines plans to phase out animal testing requirements for monoclonal antibodies and other drugs. The FDA’s roadmap introduces New Approach Methods (NAMs), incorporating AI-powered toxicity prediction tools, human-derived organoids, and organ-on-chip systems to simulate human physiological responses more accurately than traditional models. Companies submitting investigational new drug (IND) applications are now encouraged to include NAMs data and may qualify for expedited reviews if such evidence is robust.

Both agencies emphasize that animal models, while historically foundational, often fall short in replicating human disease mechanisms and drug responses. These limitations have been particularly evident in fields such as oncology and neurodegenerative disease research, where translation from animal data to human outcomes remains inconsistent.

ORIVA will also oversee changes to NIH grant review criteria, introducing evaluation metrics that prioritize translatability and human relevance. Annual reporting on NIH’s animal research funding will provide transparency into the agency’s progress toward non-animal methods.

The FDA and NIH are coordinating with other federal bodies, including the Department of Veterans Affairs, through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). 

A pilot program is being prepared to test primarily non-animal approaches for monoclonal antibody developers, with results expected to guide further policy changes.

Topics: Bioeconomy & Society