NAMs VQN PPP Design Phase Abstract for FNIH OT Proposal January 17, 2025 The National Institutes of Health (NIH) Common Fund has launched a new program, Complement-ARIE. The overarching goal of the Complement-ARIE Program is to catalyze the development, standardization, validation, and use of human-based New Approach Methodologies (NAMs) that will transform the way basic, translational, and clinical sciences are done. Specific program goals include: • Develop better models and understand human health and disease outcomes across diverse populations. • Develop NAMs that provide insight into specific biological processes or disease states. • Validate mature NAMs to support standardization and clinical use. • Complement traditional models and make biomedical research more efficient and effective. In the initial Design Phase, the NIH seeks input from the Foundation for the National Institutes of Health (FNIH) - and in alignment with the executed Request for Collaboration - to develop a public-private partnership (PPP) that enables new, impactful, and timely synergies with other relevant stakeholders as part of establishing common data elements and standardized reporting, applying validation/qualification frameworks, and accelerating deployment and regulatory implementation of NAMs. The PPP will seek to develop a Validation and Qualification Network (VQN) to establish common data elements and standardized reporting, apply validation/qualification frameworks, and accelerate deployment and regulatory implementation of NAMs. This VQN will interact with other aspects of the Complement-ARIE program as needed, but also recruit partners and projects from other ongoing efforts within the NAMs field. The Design Phase (FY25) will produce a white paper with a detailed plan to build and launch a PPP, focusing on the key primary processes of building the NAMs VQN with multiple stakeholders across academia, industry, NGOs, government, and international groups. It is anticipated that if the Design Phase is successful that two Implementation Phases to build and utilize the NAMs VQN created will follow. OTA-25-003 Abstract