The NIH Common Fund’s Complement Animal Research In Experimentation (Complement-ARIE) Program has partnered with the Foundation for the National Institutes of Health (FNIH) to enhance the adoption and regulatory use of New Approach Methodologies through the establishment of a Validation and Qualification Network (VQN). New Approach Methodologies, or NAMs, are laboratory or computer-based techniques designed to more accurately model human biology, complement traditional animal studies, and, in some cases, serve as alternatives to animal testing. Complement-ARIE and FNIH will form a public-private partnership that brings together members of multiple sectors to identify opportunities for innovation and coordination.
NAMs have shown tremendous promise in advancing the understanding of complex biological processes by more accurately mimicking human diseases and conditions. When used alone or in combination, NAMs enable researchers to answer previously difficult or unanswerable questions, particularly in areas where existing models are limited or nonexistent. The Complement-ARIE program is designed to speed the development, standardization, validation, and use of human-based NAMs to significantly advance our understanding of human health and disease by providing a range of ready and standardized biomedical research models.
The Complement-ARIE and FNIH partnership is the first phase in establishing a validation and qualification network to gather collaborators across multiple sectors to accelerate approval and deployment of NAMs for biomedical research. This partnership will include federal agencies, industry partners, and other collaborators to establish and apply reporting standards and validation frameworks to NAMs. These frameworks will prepare newly developed NAMs to seamlessly enter validation pipelines, paving the way for use by biomedical researchers on a broader scale. This public-private partnership is actively looking for biomedical scientists across the public, non-profit, and private sectors to collaborate and share expertise and resources to create and expedite the use of NAMs. Interested parties can sign up to join the partnership on the FNIH VQN website.
In addition to the VQN, Complement-ARIE will launch two additional program components. The Technology Development Centers (RFA-RM-24-010) will develop NAMs to fill in areas of greatest need with projects focused on biological complexity, high throughput techniques, combination approaches, and data sharing. The NAMs Data Hub and Coordination Center will create integrated data structures and a searchable NAMs repository, in addition to coordinating activities across all program components. (RFA-24-24-013). These program components will work in tandem to address current challenges in NAMs and create frameworks to pave the way for widespread adoption of NAMs into biomedical research.
Increased availability and use of NAMs in biomedical research has the potential to improve our understanding of human health and disease across numerous fields of study. Because these advanced systems more accurately model human biology compared to traditional approaches, widespread use of NAMs may lead to better disease treatments, decreased medication toxicity, and increased clinical trial successes.
The partnership is funded by award OT2OD039875. To learn more about the partnership with FNIH and to become a collaborator on creating the VQN, visit: https://fnih.org/our-programs/validation-qualification-network-design-phase/
