New Health Research Agency to Employ Nonanimal Strategies

The goals of ARPA-H are similar to the National Institutes of Health (NIH), but the practical work of the agency looks radically different. ARPA-H advances high-potential, high-impact health research that cannot be accomplished through typical NIH funding structures. Breaking from the research status quo is central to the agency’s mission. This transformative approach has the potential to totally change the way we conceive of and conduct medical research.

It is clear that other animal species poorly predict human clinical responses. Nonanimal research approaches, like tissue chips and organoids, improve the relevancy of research to clinical contexts while also reducing spending on costly animal experiments, and aiding in efforts to reduce and replace the use of animals in research.

In May, ARPA-H released a request for information, seeking input from stakeholders on how to accelerate innovation through a collaboration between ARPA-H and the Food and Drug Administration (FDA). Notably, the request specifically sought strategies to accelerate nonanimal research for medical product development. The collaboration of two major federal agencies to advance nonanimal research and testing strategies represents significant progress in the shift away from animal experiments.

Because accelerating human-specific nonanimal research and testing is core to the Physicians Committee’s mission and an area of expertise, our team provided ARPA-H and the FDA with important recommendations, including that these agencies lead in the widespread development and use of 3D human cell-derived experimental platforms capable of modeling every tissue and every disease. Applying human disease models will help move promising therapeutic products through the drug development pipeline more quickly and efficiently, without compromising safety—a stated goal of ARPA-H.

While the ARPA-H and FDA collaboration on accelerating nonanimal research is a necessary step forward, updates to the FDA’s policies are also necessary to reduce barriers to innovation. Despite the FDA’s authorization to accept nonanimal-based tests, practical issues remain with some of the FDA’s written policies. Many FDA regulations and guidance require or favor animal-based testing. Policy updates are needed to help ensure that drug developers can confidently use safer and more effective nonanimal-based test approaches.

The Physicians Committee continues to work with federal agencies, the research community, and the biotechnology and pharmaceutical industries, on practical solutions to progress science away from the use of animals. Momentum for change is stronger than ever.