Design Phase for Validation and Qualification Network (VQN) Public-Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs) - Complement-ARIE Program goal 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 various 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. During the Design Phase, the Foundation for the National Institutes of Health (FNIH) in collaboration with NIH developed a public-private partnership (PPP) that created a plan for 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. As part of the Design Phase the FNIH produced a whitepaper with a detailed plan to build and launch the Implementation portion of the VQN PPP. This was done in conjunction with the multiple stakeholders across academia, industry, NGOs, government, and international groups. As part of the Implementation Phase I, FNIH will enact the plan set forth in the whitepaper describing the Implementation of the VQN, including the establishment of the overarching governance structures for the PPP, the launch of new Validation and Qualification Project Development and Execution Teams, and the continuance of the VQN Cross-Cutting Workstreams around Regulatory, Community Engagement and Training, and Data Standards and Integration The PPP will enable new, impactful, and timely synergies with other relevant stakeholders as part of establishing common data elements and standardized reporting, applying validation/qualification frameworks to the specific projects on NAMs areas of criticality, as defined by the PPP members, and accelerating 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. As part of the Implementation Phase I, FNIH will enact the plan set forth in the whitepaper describing the Implementation of the VQN, including the establishment of the overarching governance structures for the PPP, the launch of new Validation and Qualification Project Development and Execution Teams, and the continuance of the VQN Cross-Cutting Workstreams around Regulatory, Community Engagement and Training, and Data Standards and Integration The PPP will enable new, impactful, and timely synergies with other relevant stakeholders as part of establishing common data elements and standardized reporting, applying validation/qualification frameworks to the specific projects on NAMs areas of criticality, as defined by the PPP members, and accelerating 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. Project Aims 1. Establish the NAMs VQN overarching Implementation governance structure for the VQN 2. Launch at least 3 initial NAMs VQN projects with the first year and an additional 2 project in each following 12-month option cycle 3. Maintain cross-cutting workstreams: Regulatory, Data Standards and Integration, and Community Engagement and Training to serve the PPP; each workstream will produce relevant deliverables that will benefit the NAMs ecosystem and will work to distribute these to all relevant stakeholders
