The Pulse
HHS Expands AI and Organoid Research to Cut Animal Testing
The U.S. Department of Health and Human Services announced more than 20 initiatives using artificial intelligence, organoids, tissue models and computational modeling to reduce animal research. The package includes new NIH funding, an FDA r
AI.info Team ·
“We are moving HHS toward a new era of biomedical research that puts human biology at the center of science,” Health and Human Services Secretary Robert F. Kennedy Jr. said Monday as the department announced a broad expansion of research methods intended to reduce animal testing.
The September 21 announcement brings artificial intelligence, computational modeling, organoids and tissue models into a department-wide plan covering biomedical research, drug regulation and public-health studies. HHS says its agencies have launched more than 20 initiatives since Kennedy took office, but the department does not claim that animal research will end across its programs.
Instead, the plan targets cases where federal agencies and researchers can use validated human-based methods to replace, reduce or refine animal studies. The full package is described in an HHS announcement released September 21, 2026.
ARPA-H Puts AI Into Drug-Safety Work
The most direct AI component sits within the Advanced Research Projects Agency for Health, known as ARPA-H. Its CATALYST program is investing in artificial intelligence and computational modeling to predict drug safety, optimize dosing and reduce reliance on preclinical animal testing.
“Artificial intelligence and advanced computational modeling can fundamentally change how we predict whether medicines will be safe for people,” ARPA-H Director Alicia Jackson said. She said the agency is developing tools that can provide information earlier in development and help move promising treatments to patients more efficiently.
HHS presents those systems as part of a wider research stack rather than a standalone replacement for laboratory work. The department is pairing computational methods with organoids, tissue models, robotics and advanced data systems designed to reproduce aspects of human biology.
NIH Plans an AI-Enabled Human Biology Lab
The National Institutes of Health announced more than $88 million in funding for biomedical infrastructure projects nationwide. NIH also announced a challenge with more than $7 million in awards for work exploring whether quantum-enabled methods can improve detection and measurement in laboratory-based New Approach Methodologies, or NAMs.
At the NIH Clinical Center, a new laboratory will combine standardized human organoid models, robotics, artificial intelligence and advanced data capabilities. HHS says the facility will support experiments on reproducible human biological systems, an effort aimed at making human-based methods easier to validate and scale.
NIH is also recruiting grant reviewers with expertise in human-based science and asking researchers whether the agency should publish an annual report tracking vertebrate animals used in NIH-funded research. NIH Director Jay Bhattacharya said the agency wants to give scientists better tools to understand disease and translate discoveries into treatments.
FDA Removes Animal-Testing References
The Food and Drug Administration issued a direct final rule Monday updating its regulations to remove references to animal testing and implement the FDA Modernization Act. HHS says the change gives drug developers greater ability to use scientifically validated alternatives when seeking to demonstrate that medical products are safe and effective.
The FDA has also issued guidance intended to reduce animal studies in drug development. According to HHS, those changes are expected to spare hundreds of non-human primates and more than one million horseshoe crabs each year.
“By removing outdated barriers to new approach methodologies, we can reduce unnecessary animal testing while making product development more predictive and efficient,” Acting FDA Commissioner Kyle Diamantas said. The announcement does not specify how quickly the revised rules will change individual development programs or regulatory submissions.
CDC Shrinks Its Animal Colony
The Centers for Disease Control and Prevention is reducing its laboratory animal colony and adding a review process for proposed animal research. The review is intended to determine whether studies fit the agency’s mission and identified public-health needs.
CDC is working to place healthy non-human primates in a qualified sanctuary and says it is conducting more than a dozen studies using NAMs. Those studies are intended to improve the country’s ability to respond to public-health threats without relying exclusively on animal models.
CDC Director Erica Schwartz said the agency is applying greater scrutiny to animal research while preserving the tools scientists need to protect the public. HHS did not provide a target date for completing the sanctuary placements or a projected percentage reduction in the colony.
A Department-Wide Shift, With Validation Still Ahead
The announcement gives HHS agencies a common direction, but the department’s own language points to a transition that depends on validation. Organoids, tissue models, AI systems and computational models must produce information that regulators and researchers can trust for specific uses before they can replace established animal studies.
HHS says its actions are designed to develop and validate methods that better reflect human biology while giving regulators more options for evaluating medical products. The department’s plan therefore combines policy changes with funding, laboratory infrastructure and new review procedures rather than relying on a single technology.
For now, the concrete commitments are the NIH’s more than $88 million infrastructure investment, the ARPA-H CATALYST program, the FDA’s regulatory update and the CDC’s reduced animal-research program. HHS says its new public webpage will track the department’s more than 20 actions to date.