The Foundation for the National Institutes of Health (FNIH) is managing a new program to advance innovative laboratory technologies that model human biology, enabling faster, less expensive testing.

A public-private partnership launched by the FNIH – in collaboration with the NIH – will accelerate the implementation of this technology. Examples include organ-on-a-chip platforms, AI models, and cell lines. These efforts are expected to reduce the reliance on animals in the laboratory.

“These innovative approaches will advance safety testing, accelerate drug development, and enhance disease modeling,” said Stacey Adam, PhD, FNIH Vice President of Science Partnerships. “Ultimately, this will support more cost-effective and human-relevant results, compared to traditional models.”

To date, more than 40 government, life science, nonprofit, and regulatory organizations have joined the partnership, called the Validation and Qualification Network (VQN). The FNIH continues to recruit partners. (Learn more at FNIH.org/VQN.)

The VQN will develop individual projects to help streamline regulatory approvals for therapies and compounds that are eventually tested using these new technologies, which are known collectively as New Approach Methodologies, or NAMs. These projects will include activities such as the establishment of common data elements and standardized results reporting.

“The Validation and Qualification Network will play a key role in advancing the use and broader regulatory acceptance of human-centered research models,” said Nicole Kleinstreuer, PhD, Acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “This work will address key challenges in NAMs adoption and implementation.”

NAMs have the potential to transform the way scientific research is conducted. These new approaches include computer models that simulate how a substance would act in the body, and cell-based tools that replicate human biology.

The VQN is part of the NIH Complement Animal Research in Experimentation (Complement-ARIE) program, which aims to complement, and in some cases replace, traditional animal testing with alternative research methods that model human biology.

The Complement-ARIE NAMs VQN is expected to lead to several additional projects to advance the development, standardization, validation, and use of human-based research technologies.

Funded by Award No. OT2OD039875 from NIH. Twenty-nine private partners have also provided funding.

Learn more at FNIH.org/VQN.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health; and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.

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“These innovative approaches ... will support more cost-effective and human-relevant results, compared to traditional models.”— Stacey Adam, PhD