Validation & Qualification Network Design Phase

Researchers have increasingly been working to develop new laboratory models that more accurately represent human biology compared to traditional models. New Approach Methodologies (NAMs) are laboratory (in vitro or in chemico) or computer-based (in silico) research approaches that have the potential to transform basic, translational, and clinical science through the development and use of new human-based biomedical research models. NAMs include pioneering technologies — such as organs-on-a-chip, AI models, and cell lines — that model human biology. The goal of the NIH-funded Complement-ARIE program is to complement, and in some cases replace, traditional animal testing with NAMs, while providing more cost-effective, human-relevant results.

The FNIH is collaborating with the NIH to establish a Validation & Qualification Network (VQN) as part of a new public-private partnership that would accelerate the deployment and regulatory implementation of NAMs. The VQN will establish common data elements and standardize reporting for preclinical, clinical, and safety performance. In addition to the VQN, Technology Development Centers and the NAMs Data Hub and Coordinating Center are the other components of the Complement-ARIE program.

This is an exciting opportunity to help transform drug discovery, chemical safety testing, and advanced disease modeling.

This initiative is currently in the design phase, which means the FNIH is establishing partnerships and convening key stakeholders during program development, coordination, administration, and fund-raising. Multiple projects may be developed based on these efforts.

What the VQN Will Do

The VQN will fill a vital role in advancing the development and use of NAMs for safety testing, drug discovery, and modeling human disease. Key activities include:

• Validation and/or qualification of novel combinatorial NAMs — using two or more platforms or technologies to address a specific issue — for regulatory and pre-regulatory use for biomedical research, safety/hazard screening, drug discovery, or drug development.
• Promoting the deployment, regulatory acceptance, and implementation of combinatorial NAMs.
• Cost-sharing with NIH to support significantly expanded efforts for validation and qualification studies.
• Operating in the pre-competitive space to build consensus frameworks and support the required studies and data packages for validation and qualification of robust, reproducible methods that will broadly benefit the scientific community and pharmaceutical, chemical, and other industries.
• Building on and accelerating existing efforts and ultimately providing more cost-effective, human-relevant/translational and rapid approaches to bring products to market.

The FNIH will act as convener, working with government, pharmaceutical, biotech, non-profit, and regulatory organizations operating in the NAMs arena. Eventually the VQN would shift to the private sector.

Complement-ARIE Consortium

The VQN public-private partnership will support an NIH program, Complement Animal Research In Experimentation (Complement-ARIE), that is working to catalyze development, standardization, validation, and use of NAMs. The Complement-ARIE Consortium also includes award recipients for the NAMs Data Hub and Coordination Center (NDHCC), as well as the Technology Development Centers.

Timeline

The VQN program design phase will be at least one year, followed by the implementation phase.

Design Year 1 Assemble partnerships, determine scope, develop governance, establish use-case selection criteria, refine goals	Implementation Years 1-5 Implement validation efforts, select and fund 4-8 use case validation studies, work with NDHCC	Implementation Years 6-10 Support NAM validation and qualification in step with Technology Development Centers

Design Phase Partners to Date

Public-Sector Partners

• Biomedical Advanced Research and Development Authority
• Consumer Product Safety Commission
• Department of Defense Congressionally Directed Medical Research Program
• Defense Threat Reduction Agency
• Environmental Protection Agency
• Food and Drug Administration
• Interagency Coordinating Committee on the Validation of Alternative Methods
• National Aeronautics and Space Administration
• National Institutes of Health
• National Institute of Standards and Technology
• National Science Foundation
• U.S. Department of Agriculture

Private-Sector Partners

• Alternatives Research and Development Foundation
• American Chemical Council
• CN Bio
• Critical Path Institute
• GlaxoSmithKline
• Health and Environmental Sciences Institute
• Hesperos
• Humane World for Animals
• Humane World for Animals International
• InSphero
• Institute for Invitro Sciences
• International Foundation for Ethical Research
• Lab Corp
• National Centre for the Replacement, Refinement, and Reduction of Animals in Research
• Novo Nordisk
• Physicians Committee for Responsible Medicine
• Radahaim
• The 3Rs Collaborative
• UCB

FNIH Contacts

• Stacey Adam, PhD, Vice President, Science Partnerships, [email protected]
• Maria Sweet, Strategic Alliances Officer, [email protected]

Funded by Award No. OT2OD039875 from NIH