The U.S. Department of Health and Human Services (HHS) revealed Monday a comprehensive push to modernize biomedical research by centering human biology and dramatically scaling back animal testing. Since Secretary Robert F. Kennedy Jr. took office, HHS agencies have rolled out more than 20 initiatives that employ human organoids, tissue models, artificial intelligence and advanced computational modeling.
Funding and New Research Infrastructure
The National Institutes of Health (NIH) announced more than $88 million in funding for biomedical infrastructure projects across the country. In addition, NIH launched a challenge offering over $7 million in awards for quantum‑enabled approaches to New Approach Methodologies (NAMs). A new laboratory at the NIH Clinical Center will combine standardized human organoid models, robotics, AI and robust data capabilities to accelerate discovery.
NIH is also recruiting grant reviewers with expertise in human‑based science and seeking public input on an annual report that would track the number of vertebrate animals used in NIH‑funded research. The agency has closed its last intramural beagle laboratory and now permits grant funds to be used for retiring or re‑homing research animals.
Regulatory Shifts at the FDA
The Food and Drug Administration issued a direct final rule clarifying that non‑animal testing may be used where appropriate for safety assessments of products intended for humans. The rule removes language suggesting animal testing is the only acceptable method, while affirming that animal studies are still permitted when scientifically justified. The FDA also released guidance to reduce animal studies during drug development and established programs to evaluate and incorporate NAMs into regulatory decisions.
Acting FDA Commissioner Kyle Diamantas said the agency is modernizing its regulatory framework so developers can use the best science available to demonstrate product safety and effectiveness. HHS estimates that these changes could spare hundreds of non‑human primates and more than one million horseshoe crabs each year.
CDC and ARPA‑H Contributions
The Centers for Disease Control and Prevention (CDC) is shrinking its laboratory animal colony, adding extra review of proposed animal research to ensure alignment with its public‑health mission, and placing healthy non‑human primates in qualified sanctuaries. The CDC is also conducting more than a dozen studies that rely on NAMs.
Meanwhile, the Advanced Research Projects Agency for Health (ARPA‑H) is investing in AI and computational modeling through its CATALYST program, aiming to improve drug‑safety predictions, optimize dosing and further reduce reliance on preclinical animal testing.
Overall Impact
Collectively, HHS says the initiatives are designed to develop and validate research methods that better reflect human biology while giving researchers and regulators additional tools to assess the safety and effectiveness of medical products. A dedicated HHS webpage now lists more than 20 actions taken to reduce animal testing and advance human‑based research methods.
These efforts represent a significant shift toward science that prioritizes human relevance, reduces animal use and leverages cutting‑edge technology to accelerate medical breakthroughs.
Original reporting: The Dallas Express — read the source article.
