In the past 18 months, the National Institutes of Health (NIH) has been working overtime to push new policies to reduce animal testing with one woman at the helm: Nicole Kleinstreuer, Ph.D.
In her role as NIH deputy director for program coordination, planning and strategic initiatives, Kleinstreuer oversees research and strategic programs ranging from women's health and disease prevention to data science and dietary supplements.
Kleinstreuer’s role sits within the office of NIH Director Jay Bhattacharya, M.D., Ph.D. One of Bhattacharya’s “top priorities” is advancing human-based science with the most modern and innovative approaches, Kleinstreuer explained to Fierce in an interview.
Having completed her bachelor’s degree in bioengineering and mathematics at the University of North Carolina at Chapel Hill, Kleinstreuer went on to obtain a Ph.D. in biomedical engineering at the University of Canterbury in New Zealand, before joining the NIH over a decade ago.
While she may now be spearheading the move away from animal testing, Kleinstreuer had been working in human-based systems rather than animal models for nearly 20 years before joining the NIH. During her postdoctoral fellowship in computational toxicology at the U.S. Environmental Protection Agency, she studied how environmental chemicals can interact with the body and cause toxic effects, without using animals.
Before her current role, she spent 10 years at the National Institute of Environmental Health Sciences, where she was the deputy director and then director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. Kleinstreuer also served as executive director of the congressionally-mandated interagency coordinating committee on the validation of alternative methods. In both roles, she spearheaded interagency and international efforts to reduce animal testing, and integrate computational modeling, artificial intelligence and systems toxicology into regulatory science.
“We started to expand more into the biomedical research sphere and trying to advance innovative technologies in furthering our understanding of human health and disease from more of a basic and mechanistic standpoint,” Kleinstreuer told Fierce.
“That increased understanding of human health and disease could more rapidly translate into improved disease insights and better therapeutics that can get to patients more quickly, while upholding our moral and ethical imperative to the American public to be the best stewards of taxpayer dollars that we can be, and invest in the most human-relevant systems for improving and optimizing human health outcomes,” she added.
The idea of reducing animal testing in research and drug development is not a new concept. In 2022, the FDA Modernization Act 2.0 was passed to remove a longstanding statutory requirement that investigational drugs undergo animal testing before being studied in humans. In a recent follow-up in July, the U.S. House of Representatives passed the FDA Modernization Act 3.0, directing the agency to update its rules to reflect the change in federal law.
Although the term “new approach methodology” (NAM) has become a buzzword recently, it was first coined back in 2016 by the European Chemicals Agency to describe in silico approaches and new high-throughput testing tools such as genomics and proteomics to better understand toxic effects. Since then, the term has evolved to encompass alternative technologies to better model human disease and capture human variability, such as using organoids or computational modeling and AI to mimic drug interactions.
The new wave of NAMs arrived in April 2025 when the FDA first announced an initiative to move away from requiring animal models for investigational new drug applications for new monoclonal antibodies and some other drug candidates.
The NIH joined the bandwagon shortly after, announcing initiatives to prioritize human-based research technologies such as organ-on-a-chip and computational models, among other real-world data-based techniques. The NIH and FDA then hosted a joint workshop on reducing animal testing in July 2025.
“We’ve gotten a tremendous amount of cooperation and support across the agency in advancing those priorities,” Kleinstreuer said. “We’re certainly building off of a foundation of very hard work and iterative improvements in technology.”
In March, the FDA’s Center for Drug Evaluation and Research (CDER) released new guidance specifying that drug approval applicants are welcome to submit data from NAMs, even if the method hasn’t previously been okayed by the agency to replace animals.
“I think what we're seeing is an unprecedented level of cooperation and collaboration between agencies right now,” Kleinstreuer said. “The FDA and the NIH are working together extremely closely.”
Another strategy employed by the organization has been awarding contracts to incentivize the shift away from animal testing. This has included announcing $87 million in contracts a year ago to launch the Standardized Organoid Modeling (SOM) Center, which took root at the Frederick National Laboratory for Cancer Research, a Maryland facility of NIH’s National Cancer Institute.
The idea is to support regulatory bodies, such as the FDA, as well as clinicians and scientists in academia and industry to develop standardized organoid models for preclinical testing of potential new drugs, thereby reducing reliance on animal modelling. The initial focus will be on organoids, which are lab-grown mini-tissue models designed to mimic human organs like the liver, lung, heart and intestine—with plans to expand to other organs down the line.
“We're hoping to get to a point where all of the institutes and centers across the agency are heavily engaged in the SOM Center, because organoids are such a promising technology to advance so many aspects of disease biology,” Kleinstreuer explained.
The SOM Center is just one example of the NIH's push to find creative solutions to biomedical and public health problems. The most recent strategic investment came last week, when the NIH announced $7 million in funds for the Quantum-Enabled and Advanced Detection Approaches for Predictive Preclinical NAMs for Toxicity and Safety (Qu-Safe) challenge.
“Qu-Safe is really exciting because it is asking teams to integrate quantum-enabled and advanced sensing technologies,” Kleinstreuer told Fierce. “Taking some of the most sophisticated tools under development right now and applying them to difficult problems … to improve biomedical measurement problems and demonstrate dramatic improvement over conventional methods.”
Kleinstreuer name-checked the potential for using quantum-enabled technologies to detect weak abundance signals, improve spatial and temporal resolution and fine-tune signal-to-noise ratios.
The NIH is not the only organization keen to explore the quantum realm, as startups and academic centers from the U.S. to the U.K., Japan and the Nordics are pushing this cutting-edge science forward at rapid speed. As Fierce has reported, the likes of Boehringer Ingelheim, Pfizer, Amgen and Merck KGaA have all been forming partnerships with quantum computing companies in recent years.
Other challenge prize competitions set up by the NIH include the data sharing index (S-index) challenge to promote sharing research data. There's also the ReGen $4 million challenge for repurposing generic drugs and a project to use AI to analyze human kidney disease biopsy tissues for a prize pot totaling $100,000, which both open in November.
“The NIH is really having a banner year in putting out challenge prize competitions,” Kleinstreuer told Fierce. “Over the last two years under this administration, we have seen an acceleration of progress and a willingness to actually advance innovation that has been unprecedented.”
“We have so many challenges that we're putting out to the community, not just our typical extramural grantees in the academic community, but very much encouraging of biotech and other industry partners to apply for these challenges as well,” Kleinstreuer said.
Earlier this summer, the NIH unveiled the Office of Research Innovation, Validation and Application (ORIVA) with the goal of speeding up the development and use of human-based research across the NIH. At the head of ORIVA sits Warren Casey, Ph.D., a long-time peer of Kleinstreuer.
She boasted that the office has already been awarded nearly $22 million in funds while operating with a mere three-person team. This cash has been put towards “infusing resources into existing programs across the agency that advance non-animal methods and human-based science,” Kleinstreuer explained.
In her role, she has helped facilitate the identification of next steps to reduce the use of animals in preclinical safety by establishing working groups focused on small molecules, biologics and more. Kleinstreuer said she hopes that in the coming months there will be more announcements and policies that better inform study design for preclinical testing.
“I think there is a lot of evidence from things like the drug-induced liver injury space, where we see that micro-physiological systems like liver-on-a-chip are far more effective at identifying liver toxicities that were not caught in preclinical animal models,” Kleinstreuer explained. “What we're really trying to do is modernize and improve that preclinical pipeline to provide better patient protection.”
In the past, Kleinstreuer has received death threats on social media from activists pressuring her to push ahead faster with the animal testing phase-out. She told Fierce that she knows this shift to reduce animal testing is a long road, and it’s important to resist the temptation to drive through the changes too quickly.
“It's certainly, you know, easier to try and claim that we should just turn everything off overnight,” Kleinstreuer said. “But, unfortunately, that would not be sustainable. We would suffer severe backlash, both from a scientific and a patient advocacy perspective.”
“What we need to do is do the hard work to make change that will last and that will further advance the most protective and predictive and rigorous science,” she added.
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