The National Institutes of Health (NIH) is following in the FDA’s footsteps—away from animal testing.
The NIH plans to establish a new office meant to develop nonanimal methods for biomedical research, according to an April 29 announcement.
The Office of Research Innovation, Validation and Application (ORIVA) will sit within the NIH’s Office of the Director and focus on advancing techniques like organoids, computational models and real-world health data analysis.
The ORIVA will coordinate with other parts of the NIH to develop, validate and scale nonanimal biomedical research methods, according to the release. The new office will also expand funding, training and awareness of nonanimal methods to researchers.
The NIH will also hold trainings for grant review staff to address any bias they may have in favor of animal-based methods and plans to incorporate experts in alternative methods into study sections, the agency said.
“For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” NIH Director Jayanta Bhattacharya, M.D., Ph.D., said in the release. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted.”
The agency did not share how much money the ORIVA will receive to conduct this work. A document leaked earlier this month revealed the Trump administration’s apparent plans to slash the NIH’s budget by about 40%, from $47 billion to $27 billion. The administration has also terminated numerous NIH grants, pulled the agency’s funding to universities like Harvard and fired more than 1,000 NIH staffers.
At the time of publication, the NIH had not provided answers to Fierce Biotech’s questions about when the ORIVA will open, who will lead it or what the office’s budget will be. The Department of Health and Human Services, which oversees the NIH, did not respond to a request for comment.
The NIH announcement comes just weeks after the FDA unveiled a plan to phase out requirements for new monoclonal antibody drugs to be tested in animals.
“By leveraging AI-based computational modeling, human organ model-based lab testing and real-world human data, we can get safer treatments to patients faster and more reliably while also reducing R&D costs and drug prices,” FDA Commissioner Marty Makary, M.D., said in the agency’s April 10 announcement.
After the FDA’s announcement, the National Association for Biomedical Research (NABR), a nonprofit organization that advocates for “ethical and essential animal research,” said in a statement that alternative methods are not yet ready to replace animal testing.
“We all want better and faster ways to bring lifesaving treatments to patients,” NABR President Matthew Bailey said in the statement. “But no AI model or simulation has yet demonstrated the ability to fully replicate all the unknowns about many full biological systems.”
In a call with Fierce Biotech following the NIH’s April 29 announcement, Bailey reiterated that point while also expressing support for the NIH effort.
“We are not opposed to the development of new technologies that could reduce the number of animals used in research or potentially replace them,” Bailey said. “But we also try to be very realistic about where we are with these things.”
And when it comes to basic research into how biological systems work, Bailey added, there’s no replacement for studying where that system naturally occurs.
“For basic research at the university level, they're still going to need animal models,” he said.
Animal rights groups have applauded the NIH’s plan.
“Shifting away from animal-based models isn’t a trend,” Kitty Block, president and CEO of Humane World for Animals, said in an April 29 release. “It’s a mission grounded in science, ethics and relentless advocacy.”