GATC Health Joins Critical Path Institute’s New Approach Methodologies Developer Coalition to Advance AI-Enabled Regulatory Science

GATC to contribute AI-native, in silico drug discovery and predictive modeling expertise and insights to collaborative effort advancing the validation, qualification and adoption of human-relevant drug development tools

C-Path is an independent nonprofit public-private partnership advancing regulatory science and accelerating drug development through collaboration with the FDA, industry, and researchers

GATC executives to attend C-Path’s 2026 Global Impact Conference September 15–16 in Washington, D.C.

IRVINE, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) -- GATC Health Corp (“GATC”), a tech-bio company applying artificial intelligence and multiomics to accelerate drug discovery and development, today announced that it has joined the Critical Path Institute’s^® (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC), a precompetitive coalition working to advance the adoption, validation and qualification of new approach methodologies (NAMs) for drug discovery and development.

GATC was invited to join NAMs-DC as a contributing member, and as the first AI-native drug discovery and development focused collaborator. GATC brings to the coalition a systems-level approach to in silico modeling of human biology and the prediction of drug safety and efficacy. Through its participation, GATC will work alongside NAM developers, pharmaceutical and biotechnology companies, regulators and other stakeholders to help advance frameworks for evaluating and integrating human-relevant methodologies into drug development.

“Today, AI models are already playing a role in determining which drug candidates advance through development, yet there is still no broadly accepted framework for evaluating the quality, reliability, and performance of those models,” said Jayson Uffens, Chief Technology Officer and Chairman of GATC Health. “No single company can establish that standard independently. Internal performance metrics are important, but they do not, on their own, create a common benchmark for the field. We joined NAMs-DC to bring the in silico capabilities behind Operon^® into direct dialogue with technology developers, biopharmaceutical companies and regulators, and to help advance a shared understanding of what meaningful qualification should look like.”

Launched in 2026, NAMs-DC brings together developers of technologies including complex in vitro systems and computational models to help address a longstanding challenge in drug development: translating promising new methodologies into validated and qualified tools that can be used confidently within defined contexts. The coalition engages developers, biopharma companies and global health authorities to advance common qualification approaches and support broader regulatory adoption of NAMs.

GATC’s proprietary Operon^® platform integrates multiomic data, artificial intelligence and predictive modeling to simulate complex human biology and assess how drug candidates may perform before clinical testing. The platform is designed to identify potential efficacy, toxicity, off-target effects and other risk signals earlier in development, providing a human-biology-driven complement to conventional preclinical approaches.

“Expanding the range of methodologies represented within NAMs-DC is essential to building qualification approaches that can keep pace with innovation in drug development,” said Graham Marsh, Ph.D., Scientific Director at Critical Path Institute and program lead for NAMs-DC. “GATC brings a distinct computational and in silico perspective to the coalition, and we look forward to its contributions as we work across the developer community, industry and regulators to advance human-relevant tools that will positively impact drug development.”

GATC’s addition to NAMs-DC comes ahead of C-Path’s 2026 Global Impact Conference, taking place September 15–16 at the Washington Marriott at Metro Center in Washington, D.C. The conference convenes regulators, industry leaders, scientists, clinicians, patient representatives and other stakeholders to address challenges in modern drug development, including discussions on advancing NAMs as drug development tools.

Tyrone Lam, Chief Business Officer of GATC Health, and Eric J. Mathur, Chief Innovation Officer of GATC Health, will attend the conference on behalf of the company, participating in discussions around the evolving role of NAMs, computational approaches and artificial intelligence in drug discovery, development and regulatory evaluation.

“Whether AI can meaningfully predict how drug candidates may behave in humans is becoming increasingly established. The more important question now is which methods can withstand independent scrutiny, and demonstrate that their outputs can inform real development decisions,” added Uffens. “That is the work in front of the field, and we believe it is critical for GATC to contribute directly to shaping those standards rather than observe from the sidelines.”

About GATC Health

GATC Health is a tech-bio company revolutionizing drug discovery and development by simulating complex human biology to predict how drugs will perform in the body, achieving 91% specificity and 86% sensitivity. Trusted by the world’s largest insurance marketplace, biopharma, researchers, and investment partners, GATC Health’s risk prediction product, the Derisq™ AI report, accurately assesses and predicts drug candidate safety, efficacy, and non-obvious side effects prior to the commitment of development capital. GATC Health’s AI platform is also generative, creating novel intellectual property, extending pipelines, and optimizing assets. By uniting advanced AI, multiomics, and predictive modeling, GATC Health accelerates breakthroughs and reduces costly late-stage failures to bring safer, more effective therapies to patients worldwide. For more information, visit gatchealth.com.

About Critical Path Institute

Critical Path Institute^® (C-Path) is an independent, nonprofit organization established in 2005 as a public-private partnership in response to the U.S. Food and Drug Administration’s Critical Path Initiative. C-Path leads collaborative programs bringing together regulatory agencies, industry, academia, patient organizations and other stakeholders to advance tools and approaches that accelerate drug development worldwide.

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GATC Health
Amanda Rice
arice@lifescicomms.com