U.S. Health Agencies Redirect $95 Million to Accelerate Human-Based Biomedical Research
The Department of Health and Human Services and the National Institutes of Health have launched a coordinated effort to fund non-animal testing technologies, including organ-on-a-chip systems and AI models. The policy shift aims to modernize preclinical science by prioritizing human biology over traditional animal models.
By Ishani Patel
- Federal Health Agencies
- Focus on modernizing infrastructure, improving drug translation rates, and updating regulatory language to support human-based models.
- Animal Welfare Advocates
- View the shift as a long-overdue ethical and scientific victory that will scale down the use of live animals in laboratories.
- Scientific Transition Observers
- Emphasize the mechanical advantages of organ-on-a-chip and AI models over animal testing, while noting that a complete phase-out remains technologically distant.
Perspectives this story doesn't cover
- Traditional biomedical researchers reliant on animal models
- Pharmaceutical industry representatives
On September 21, 2026, the National Institutes of Health allocated $88 million to 10 construction projects across the United States, explicitly directing the funds toward facilities designed for human-based research methodologies. The grants represent the financial anchor of a broader policy shift announced the same day by the Department of Health and Human Services (HHS), which rolled out more than 20 initiatives aimed at moving federal biomedical science away from animal testing.[1][2]
Before a new compound can be tested in human clinical trials, researchers must determine its toxicity and efficacy. Historically, this required administering the drug to animal models—often mice, dogs, or non-human primates—and observing the physiological response. However, because a mouse's metabolic pathways and cellular receptors differ fundamentally from a human's, these models frequently fail to predict how a drug will actually behave in patients. To solve this biological translation problem, scientists have developed New Approach Methodologies (NAMs). These include organ-on-a-chip devices, which use microfluidic channels lined with living human cells to simulate the mechanical and chemical environment of entire organs, allowing researchers to observe human-specific cellular responses in real time.[4]
The newly announced NIH funding is designed to build the physical infrastructure required to scale these technologies. Alongside the $88 million in construction grants, the agency launched a $7 million challenge to develop quantum-enabled sensing systems capable of measuring biological signals in lab-based NAMs. Furthermore, the NIH Clinical Center will house a new Bio Genesis Autonomous Human Biology Laboratory, which will integrate standardized organoids, robotics, and artificial intelligence into a closed-loop experimental platform.[1][2]
"NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology," said NIH Director Jay Bhattacharya. The goal, he noted, is to provide researchers with tools that can translate discoveries into treatments more reliably than current methods allow.[1][2]
"NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology," said NIH Director Jay Bhattacharya.
The push extends beyond the NIH. HHS Secretary Robert F. Kennedy Jr. stated that the department is modernizing outdated regulations and breaking down barriers that have kept researchers dependent on animal models when better tools are available.[2]
In parallel, the Food and Drug Administration (FDA) issued a direct final rule updating its regulations to remove language that previously suggested animal testing was the only acceptable way to generate safety data for regulatory decisions. This aligns agency rules with the FDA Modernization Act of 2022, which legally recognized modern technologies as viable alternatives to animal trials.[2][3]
Animal welfare organizations, which have long lobbied for these changes, welcomed the announcements. Animal Wellness Action praised the FDA for stripping out archaic language that contradicted modern technological capabilities, noting that federal drug-screening regulations now formally recognize human cell-based systems and sophisticated computer models.[3]
While the federal government is heavily incentivizing the transition, the complete replacement of animal models remains a distant target. The FDA noted that its rule change does not eliminate or prohibit animal studies, as current alternative technologies cannot yet replicate every aspect of a living, complex biological system. To track the transition, the NIH has issued a request for information from the scientific community to assess the feasibility of publishing an annual report on the number of vertebrate animals still used in federally funded labs.[1][2]
Key points
- The NIH is investing $88 million in 10 construction projects to build infrastructure for human-based research methodologies.
- An additional $7 million will fund quantum-enabled sensing systems for lab-based New Approach Methodologies (NAMs).
- The FDA updated its regulations to remove language suggesting animal testing is the only acceptable way to generate safety data.
- The policy shift aims to improve drug development by using technologies that better reflect human biology.
Viewpoints in depth
Federal Health Agencies
HHS and NIH are prioritizing infrastructure and regulatory updates to improve the predictive power of preclinical research.
Agency leaders argue that traditional animal models are increasingly a bottleneck in drug development due to their failure to accurately predict human responses. By investing $95 million into human-based technologies and removing FDA language that mandated animal testing, the government aims to build a new preclinical ecosystem centered on human biology.
Animal Welfare Advocates
Advocacy groups view the policy shift as a major milestone in the effort to end animal testing.
Organizations like Animal Wellness Action have spent years lobbying for the implementation of the FDA Modernization Act. They argue that the combination of NIH funding for alternative methodologies and the FDA's formal rule change provides the necessary regulatory and financial weight to finally move the pharmaceutical industry away from relying on animal subjects.
Why this matters
By shifting federal funding and regulatory approval pathways away from animal testing and toward human-based models, new drugs and treatments could be developed faster, more safely, and with higher success rates in human clinical trials.
Sources
[1]NIHFederal Health AgenciesNIH makes major investments to advance human-based research infrastructure and technologies
Read on NIH →
[2]WBAPScientific Transition ObserversHHS Accelerates Shift To Human-Based Research, Reduces Animal Testing
Read on WBAP →
[3]Animal Wellness ActionAnimal Welfare AdvocatesHHS Moves To Scale Down Animal Use In Research And Testing
Read on Animal Wellness Action →
[4]Factlen Editorial TeamScientific Transition ObserversSynthesis by Factlen editorial team
Read on Factlen Editorial Team →
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