In a watershed moment for preclinical and biomedical research, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have unveiled bold plans to reduce reliance on and shift away from animal testing. The strategy emphasizes the application of advanced, human-relevant methods, like New Alternate Methodologies (NAMs), such as Organ-on-a-chip (OOC) technology, also known as Microphysiological Systems (MPS), AI-based models, and organoids, with animal testing becoming the exception rather than the rule.

A groundbreaking policy shift

On April 10, 2025, the FDA released a landmark roadmap aimed at phasing out animal research with a shift away from animal testing requirements for certain therapies, particularly highlighting monoclonal antibody (mAbs)- based drugs. The agency is encouraging the submission of New Approach Methodologies (NAMs), with potential incentives like streamlined review for submissions that rely on strong NAMs data.

Complementing this, the NIH followed suit, a couple of weeks later, by announcing its intent to prioritize grant proposals based on non-animal research methods. It also established the Office of Research Innovation, Validation, and Application (ORIVA) to spearhead the development, validation, and implementation of these innovative approaches across the agency’s biomedical portfolio.

Collectively, the FDA and NIH are steering research toward more human-relevant methods, such as, human organoids, OOC, AI-driven analyses, and real-world population health data as powerful alternatives to traditional animal models. The FDA is also projecting that animal testing will become “the exception rather than the norm” within the next three to five years.

Voices of enthusiasm…and caution

Tomasz Kostrzewski, CSO at CN Bio, expressed genuine surprise and clear optimism. “It’s fantastic,” he remarked. “There’s a place for animals in drug discovery, but animal research shouldn’t be the go-to.”

Joseph Wu, a Stanford Medicine cardiologist and co-founder of Greenstone Biosciences, echoed this view, pointing to the frequent lack of human relevance in animal models—especially inbred mice—and praising the potential of stem-cell derived organoids to accelerate high-throughput screening of candidate therapies.

Aysha Akhtar, CEO of the Center for Contemporary Sciences, warned pharmaceutical firms to embrace this shift swiftly to avoid the risk of being “left behind”.

Despite the excitement, experts also stress that NAMs are not yet ready to fully replace animal use but support the shift away from animal testing. Organoid models, often lack the complexity of full human physiological systems, while some advanced models and AI systems pose additional implementation costs, infrastructure demands and workforce training requirements.

Looking Ahead

The FDA and NIH’s joint push toward human-based, AI-driven, and organ-mimetic models signals a profound transformation in biomedical research. Tomasz Kostrzewski’s optimism captures the pioneering spirit of this shift, yet its success hinges on robust validation, funding, and institutional will.

Original article was published in BioCompare on 19 May, 2025.

Dr. Tomasz Kostrzewski

Chief Scientific Officer

Dr. Tomasz Kostrzewski has more than 15 years of experience in molecular and cellular biology research. He joined CN Bio in 2015 and was promoted to Director of Biology in 2018 with responsibility for biological model development and collaborative research projects with academia, pharma, and regulators. In 2021 he was promoted to VP of Science and Technology and then to Chief Scientific Officer in 2023, with responsibility for all technical activities, including developing new products, technologies, and assays, as well as contract research services. Dr Kostrzewski has managed multiple grant-funded collaborative projects at CN Bio and is currently the project lead for the collaborative project between CN Bio and the FDA. He has published more than twelve peer-reviewed scientific articles in the last five years and submitted several patent applications. Prior to joining CN Bio, he worked at Imperial College London in the Department of Life Sciences studying immune cell development and stem cell differentiation, as well as at GlaxoSmithKline working in biopharmaceutical drug discovery and development. Dr Kostrzewski holds three degrees from the University of Sheffield and Imperial College London in Cell and Molecular Biology.