GATC Health’s AI Platform Applauds the FDA’s Newly Announced Plan for Eliminating Animal Testing in Drug Discovery by Using AI

Irvine, CA – April 16, 2025 – GATC Health Corp, a leading tech-bio company leveraging artificial intelligence (AI) to transform drug discovery, applauds the U.S. Food and Drug Administration’s (FDA) plan to phase out animal testing requirements for monoclonal antibodies and other drugs and adopt a number of alternative approaches including AI-based computational models.

The FDA’s Planned Phase-Out of Animal Testing

The efforts of the FDA to reduce animal testing in preclinical safety studies is based on growing scientific evidence that animals provide inadequate models for human health and disease. In fact the FDA in its published Roadmap has recognized that while over 90% of drugs that initially appear safe and effective in animal studies do not go on to receive FDA approval in humans predominantly due to safety and/or efficacy issues.

GATC Health has been a vocal advocate for New Approach Methodologies (NAMs) as a viable alternative to animal testing in pre-clinical drug research. On April 7, 2025, GATC Health submitted its comments to the FDA on Considerations for the Use of Artificial Intelligence To Support Regulatory Decision. “Animal models have inherent limitations due to interspecies differences. Our Multiomics Advanced Technology™ (MAT) platform, trained exclusively on human data, bypasses these gaps by simulating human biology at scale, delivering data that is both more reliable and ethically aligned with modern standards,” noted Ian Jenkins, GATC Health’s Chief Science Officer. 

Partnering With Industry Leaders for Change

GATC Health is partnering with several industry leaders across the globe to support policy and legislation that reduces and ultimately eliminates the dependence on animal testing.  GATC Health President, Dr. Rahul Gupta, MD, MPH, MBA is invited to join the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) board meeting on May 12. CAAT is dedicated to being the leading force in the development and use of reduction, refinement, and replacement alternatives in research, testing, and education to protect and enhance the health of the public. “By leveraging AI-based computational modeling such as GATC Health’s MAT platform, we can discover safer, faster and more cost-effective treatments for Americans,” stated Dr. Gupta. 

Additionally, GATC Health’s Ian Jenkins and its Chief Innovation Officer, Eric Mathur, are members of Humane World for Animals’ (formerly Humane Society) non-animal working group to support policy and legislation that reduces dependence on animal testing. GATC Health is proud to advance the development, application and use of human-relevant tools that not only prevent harm to animals but also provide more accurate information for human patients.  

GATC Health’s MAT Platform Meets FDA Requirements

GATC Health’s MAT platform holds the promise to play a critical role in advancing human-focused regulatory decision-making. It meets the FDA’s NAMs requirements with the tools to assess safety, efficacy, and side effects of drugs and therapeutics without traditional animal models. GATC Health’s MAT AI platform has been validated by university studies, global leaders in finance and insurance, biotech customers, and industry-leading advisors to predict human outcomes with sensitivity scores of 86% and specificity scores of 91%. The MAT platform is ideally suited to deliver the insights sought by the industry, the FDA, and proponents of non-animal research alternatives.

Producing “Human Relevant” Data for the FDA

With its MAT technology platform, GATC Health can more accurately predict human outcomes, reduce costs while eliminating ethical concerns, and provide guidance for key decisions based on its validated platform’s data. The company believes it is uniquely positioned to fulfill the needs of the FDA’s new plan to replace animal testing with human relevant data to accelerate and de-risk the Investigational New Drug (IND) process.

About GATC Health

GATC Health Corp. is a tech-bio company transforming drug discovery and development through its AI-driven platform and approach. The company’s validated and proprietary Multiomics Advanced Technology™ (MAT) simulates human biochemistry’s billions of interactions to rapidly create novel therapeutics, identify and confirm targets, accelerate development, and de-risk drug pipelines by predicting efficacy, safety, and off-target effects.

For more information, visit www.gatchealth.com.