GATC Health Announces Support for FDA's Regulatory Decision-Making Modernization with AI-Driven Insights

Irvine, CA – April 9, 2025 – GATC Health Corp, a leading tech-bio company leveraging artificial intelligence (AI) to transform drug discovery, is proud to announce its support for the U.S. Food and Drug Administration (FDA) as the agency seeks to modernize regulatory decision-making processes using artificial intelligence (AI). In response to the FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” GATC Health has submitted detailed comments emphasizing the transformative potential of its proprietary Multiomics Advanced Technology™ (MAT) platform.

This announcement comes at a pivotal moment as the incoming FDA Commissioner, Johns Hopkins surgeon and professor Dr. Marty Makary, has called for greater efficiencies, modernization, and expanded use of AI in healthcare regulation. A recent Forbes article noted about his confirmation, “Throughout the hearing, he offered insight on how he would achieve those goals, including leveraging artificial intelligence and making other regulatory changes to streamline the drug review process.”

The Commissioner’s vision aligns with GATC Health’s mission to accelerate drug development timelines while improving precision and safety—a goal that resonates with statements made by Health Secretary Robert F. Kennedy Jr., who has highlighted the positive role AI can play in improving healthcare.

“The FDA has an unprecedented opportunity for AI to radically streamline regulatory processes that can drag out for a decade or more,” said Jayson Uffens, GATC Health’s CTO. “Our platform has been proven to predict the outcomes of human drug trials with more than 85% specificity using pre-clinical data. It’s a platform that can save the industry billions, expedite drug approvals, and raise the bar on safety and efficacy.”

In its comments to the FDA, GATC Health emphasized several key points:  

• Human-Centric AI Modeling: Instead of relying heavily on animal testing, GATC Health’s platform uses human data exclusively to prioritize predictive success in human drug trials. This approach reduces reliance on animal studies while enhancing accuracy and ethical standards.  

• Capital Efficiency: By streamlining processes such as disease target identification, optimizing preclinical validation and lowering failure rates, MAT significantly reduces costs and time associated with traditional drug discovery methods—critical for addressing the inefficiencies highlighted by FDA leadership.  

• Validated Predictive Capabilities: Through partnerships like the one with Lloyd’s of London syndicate Medical & Commercial International (MCI), GATC Health’s AI models have demonstrated their ability to forecast clinical trial outcomes with high accuracy.  By identifying drug candidates with a high likelihood of success, GATC Health’s platform enables MCI to insure the cost of drug trials, greatly reducing financial risk for drugmakers and their partners.  

GATC Health commends the FDA for its forward-thinking approach in drafting guidance that recognizes the importance of AI in regulatory decision-making. The company’s submitted comments advocate for standardized frameworks that ensure data quality while encouraging innovative applications of AI models. Additionally, GATC Health proposes implementing blind challenges as a validation method to foster transparency and benchmark progress across AI platforms.

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.