New Approach Methodologies (NAMs) are laboratory or computer-based research approaches intended to more accurately model human biology than traditional research models. These innovative human-based technologies range from organ-on-a-chip systems to Artificial Intelligence and Machine Learning (AI/ML) approaches and demonstrate an exciting potential to accelerate our understanding of health and disease.

The NIH Complement-Animal Research in Experimentation (Complement-ARIE) program team published a review describing the state of NAMs research and how Complement-ARIE’s strategic planning initiatives have set the stage for the program to catalyze use and adoption of NAMs. 

Strategic planning efforts included:

• An interagency meeting: Ten federal agencies and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) held a two-day retreat to discuss goals, priorities, and challenges for advancing NAMs.
• Public listening sessions: More than 850 key representatives from various sectors — including industry, academia, non-government organizations, U.S. government, and international partners — took part in three public events aimed at gathering insights on current opportunities and roadblocks in NAMs development.
• A landscape analysis: This report included a survey of advanced biological cell models, techniques to assess chemical reactivity without involving biological systems, and computer modeling systems like AI/ML. The landscape analysis helped to define the scope of Complement-ARIE by identifying what NAMs have the potential to reduce reliance on animal models while still improving our understanding of human health and disease
• The ideation challenge prize: Complement-ARIE launched a crowdsourced prize competition to find new ideas for NAMs development that could benefit from further investment. The winning proposals addressed gaps identified during other strategic planning efforts and highlighted ways to develop integrated NAMs that can advance understand of human health and disease.

Informed by these collaborative efforts, the Complement-AIRE program has launched several new funding initiatives:

• Technology Development Centers (TDCs): The TDCs aim to support the development of NAMs using multiple methods to address questions about human biology and disease. TDCs will have built-in training and outreach components to ensure that NAMs can be adopted and deployed in the future by an informed and engaged research workforce.
• NAMs Data Hub and Coordinating Center (NDHCC): The NDHCC will integrate NAMs-relevant data structures via a central data hub and will help to develop and apply standards for data reporting and model credibility. The NDHCC will prioritize adherence to findable, accessible, interoperable, and reusable (FAIR) data principles.
• Validation and Qualification Network: The NIH, in collaboration with the Foundation for the NIH (FNIH), is establishing a Validation and Qualification Network (VQN) through a Public-Private Partnership. This partnership will engage scientists from multiple levels of government (including funding agencies and regulators), industry, nongovernmental organizations, and academic institutions. Through this combined expertise, in an environment where partners can securely share ideas and resources, the VQN will establish a process for evaluating NAMs and guiding use cases. This will help support broader adoption and application on NAMs by industry and biomedical researchers.

These extensive efforts by the Complement-ARIE program are happening at a time when NIH and other federal agencies have identified the potential of NAMs to improve human health and are moving to accelerate their deployment. The FDA announced a roadmap to reduce animal testing in preclinical safety studies and the EPA is prioritizing ongoing efforts to develop and use NAMs to test chemicals for health effects. Through these combined federal efforts, NAMs are poised to more efficiently support the development and approval of new treatments and catalyze advances in health and disease research through human-based solutions.    

References

Sunderic, K., Wright, A. M., Kleinstreuer, N., Ledbetter, V., Milora, K. A., Happel, C., Shaughnessy, D., Johnstone, C. P., Casco, D. A., Macioce, N., Marzec, J., Kano, K., Ochocinska, M. J., & Tagle, D. A. (2025). Complement-ARIE: Catalyzing the Development and Adoption of New Approach Methodologies. NAM journal, 1, 100026. https://doi.org/10.1016/j.namjnl.2025.100026