GATC Health Welcomes Coordinated Federal Actions Advancing New Approach Methodologies

Actions across HHS, including FDA and NIH, underscore growing federal momentum behind human-relevant approaches to drug development

IRVINE, Calif., September 25, 2026 – GATC Health today welcomed a series of federal actions aimed at accelerating the development, validation and adoption of New Approach Methodologies (NAMs) and other human-relevant research technologies. Animal models often fail to predict human responses. NAMs, such as GATC’s Operon^® platform, strive to deliver improved science while reducing reliance on animal testing.

Announced September 21, the actions reflect increasing alignment across the federal research and regulatory ecosystem:

• FDA updated its regulations to clarify that scientifically appropriate non-animal methods may be used in nonclinical drug development and launched a database highlighting real-world examples of NAM use.
• NIH announced major new investments in human-based research infrastructure and technologies, including more than $88 million in research facilities funding and additional initiatives supporting NAMs, organoids, artificial intelligence and advanced data capabilities.
• HHS outlined a broader department-wide effort spanning more than 20 initiatives to advance human-based science and reduce unnecessary reliance on animal models.

“What changed is the default. Nonclinical no longer means animal by definition,” said Jayson Uffens, Chief Technology Officer, Co-Founder and Chairman of GATC Health. “What did not change is what a reviewer needs to see. Prediction is cheap now. Evidence that a prediction was right is not. The field has to build that together, and it has not yet.”

The announcements come shortly after GATC joined the Critical Path Institute’s New Approach Methodologies Developer Coalition (NAMs-DC), a precompetitive coalition focused on advancing the validation, qualification and regulatory adoption of NAMs.

Through NAMs-DC, GATC is contributing an AI-native and in silico perspective alongside technology developers, biopharmaceutical companies, regulators and other stakeholders working to advance human-relevant drug development tools.