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GATC Health Welcomes the FDA Modernization Act 2.0, Allowing New Drug Candidates to Bypass Animal Testing Using Computer Modeling
News provided byGATC Health Corp
Jan 25, 2023, 9:55 AM ET
This legislation is expected to create more demand for GATC's drug discovery and development platform as AI and machine learning are increasingly used in advancing drug leads to human trials
IRVINE, Calif., Jan. 25, 2023 /PRNewswire/ -- GATC Health, a science and technology company revolutionizing drug discovery and disease prediction using artificial intelligence (AI), today announced that the FDA Modernization Act 2.0 signed into law in December 2022, ends an FDA mandate that experimental drugs must be tested on animals before they are used on humans in clinical trials. The new legislation allows emerging technologies, including GATC's computer modeling that predicts a potential drugs safety and efficacy in humans, to be used to advance drug leads to human trials without the requirement of animal testing.
In 1938, Congress passed the U.S. Federal Food, Drug, and Cosmetic Act, mandating animal toxicity testing. Since then, science and data has shown that animal testing is highly inconsistent in predicting toxic responses in humans. More than nine in 10 drugs that enter FDA human clinical trials fail and do not get to market because they are unsafe or ineffective. The new FDA Modernization Act 2.0 stipulates that new drug candidates are no longer required to undergo animal testing prior to initiation of human trials and signals a major shift towards computer modeling as the preferred method to simulate the safety and efficacy of novel compounds in humans before drugs are approved by the FDA.
Artificial intelligence reached its "AlphaGo" moment for pharma in 2018, according to Deep Pharma Intelligence, with validating breakthroughs by IBM Watson, Insilico, Healx and DeepMind occurring that year. GATC Health's validated and proprietary Multiomics Advanced Technology™ (MAT) platform is mature, in production and ahead of the curve. MAT surpasses current AI for drug discovery by simulating human biochemistry's billions of interactions for accurate and rapid disease prediction, novel target identification, and drug discovery and development. GATC's computer simulation models use human biological components to more accurately predict medical and biological outcomes than animal testing. In a triple-blind retrospective study analyzing 14,000 known compounds, MAT accurately identified drug candidates that would have a beneficial effect on human biology with 88% accuracy while spotting failures with 84% accuracy. GATC is currently in advanced preclinical trials with novel compounds that were discovered and modeled utilizing GATC's MAT platform.
"It is important to realize that while an animal's biological components may be similar to their human counterparts, they are not identical. Theses subtle differences can result in erroneous interpretations," says Dr. Jonathan Lakey, Professor Emeritus of Surgery and Biomedical Engineering University of California Irvine and GATC Health Advisor. "We believe GATC's computer modeling can more rapidly and accurately predict physiological response to novel compounds better than animal testing, potentially saving years, costs and lives."
GATC Health's advanced AI platform reduces risk, time, and cost in developing more effective drugs and treatments. GATC can analyze a massive amount of disease-specific data, with an AI solution that understands the core biology of a disease and can mimic a human environment for the discovery and validation of novel drugs. The company's MAT platform can analyze 400 trillion biological data points in seven minutes and simulate biochemical interactions to accurately predict the response of a pharmaceutical asset to a specific disease. Through rapid and accurate simulation, the MAT platform can develop 1-3 novel drug candidates in 3–6 months with the ability to support end-to end services across research and development.
GATC Health Corp is a science and technology company revolutionizing disease prediction and drug discovery and development through its transformative AI platform and approach, which de-risks drug pipelines and accelerates new therapies to treat disease with accuracy, efficiency and speed never before achieved in medical science. The company's validated and proprietary Multiomics Advanced Technology™ (MAT) platform simulates human biochemistry's billions of interactions for accurate and rapid disease prediction, novel target identification, and drug discovery and development. GATC envisions the future of medicine now, where health is protected, disease is reversed, and every person's unique biology is treated with precision.
GATC is accelerating the future of predictive, individualized medicine, today.
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SOURCE GATC Health Corp