ICCVAM Biennial Report 2024-2025

NAMs include tools such as advanced computer models (in silico), complex 3D cell models (in vitro), and other specialized technologies such as cell-free systems, digital twins, and MPS. Over the past 15 years, NIH has significantly increased investment in these methods, recognizing their ability to enhance research while complementing traditional animal models.

In 2024, NIH approved the Complement Animal Research in Experimentation (Complement-ARIE) program to accelerate the development, validation, and adoption of NAMs, especially those that combine different approaches to more accurately model human biology and diseases (Sunderic et al. 2025). The program focuses on four key goals:

1. Using NAMs to complement traditional animal models, making research more effective
2. Validating mature NAMs to gain regulatory approval for widespread use
3. Modeling human health differences across populations, including personalized insights
4. Developing innovative methods to study specific biological processes or disease states

To inform its strategy, the NIH conducted strategic planning activities, including an interagency retreat, public listening sessions, and scientific analyses, along with the organization of an innovation challenge prize. These efforts helped identify key opportunities and address challenges related to the implementation of NAMs, such as improving standardization and overcoming operational roadblocks.

The Complement-ARIE “Ideation” Challenge Prize competition, announced in late 2023 as part of the strategic plan, offered $1,000,000 in total prize money to multidisciplinary teams with ideas for new ways of using NAMs. Twenty winning teams each received $50,000 to develop new ways to use NAMs, which NIH used to understand gap areas, innovative spaces, and areas of greatest need that could be addressed by the Complement-ARIE program.

In April 2025, Complement-ARIE launched its Validation and Qualification Network to accelerate regulatory approval and deployment of NAMs for biomedical research. The Validation and Qualification Network will work with regulatory authorities from other federal agencies, industry partners, and other collaborators to establish and apply validation/qualification frameworks to NAMs. These frameworks will prepare newly developed NAMs to more easily enter validation pipelines and regulatory review, paving the way for NAMs use on a broader scale by researchers in industry and biomedical research. In August 2025, the Foundation for NIH invited developers to submit NAMs for initial assessment by the Validation and Qualification Network.

In September 2025, Complement-ARIE issued the NAMs Reduction to Practice Challenge Prize competition. This open competition, with $7,000,000 in total prize money, tasks innovators with accelerating the technological development of near-ready integrated NAMs platforms and translating their products into practice. Top-scoring submissions will be delivered to the Validation and Qualification Network for validation and qualification.