Design Phase for Validation and Qualification Network (VQN) Public-Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs)

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

Grant Number: 1OT2OD039875-01
NIH Institute/Center: NIH
Principal Investigator: Stacey Adam