https://ntp.niehs.nih.gov/go/n545391

NIH announces new human-based science initiative

In April 2025, NIH announced an initiative to expand innovative, human-based science to improve health and disease research and medical product development while reducing animal use. The initiative seeks to provide more predictive models of human disease by leveraging human-derived data and advanced technologies such as MPS (“organs-on-chips”), 3D organoids, and AI-driven digital twins. By prioritizing research that better reflects human biology, the NIH aims to bridge the translational gap where animal models fail to predict human outcomes, particularly in complex areas such as neurodevelopment and chronic disease, while simultaneously reducing the scientific community's reliance on animal models. In August 2025, the NIH released a unified strategy that reiterated the agency’s commitment to develop and apply human-based NAMs and reduce animal use. To lead this initiative, NIH is establishing an Office of Research Innovation, Validation, and Application to coordinate efforts to develop, validate, and scale the use of NAMs across the agency’s biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for public health protection.