April 10 (UPI) — The U.S. Food and Drug Administration is replacing animal testing with human-relevant methods, including artificial intelligence, when developing monoclonal antibody therapies and other drugs.
The regulatory change is intended to improve drug safety and accelerate the evaluation processing while reducing animal experimentation, lowering research and development costs and lowering drug prices, the FDA announced Thursday.
The change also makes greater use of AI while developing and testing new drugs.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” FDA commissioner Martin Makary said.
“By leveraging AI-based computational modeling, human organ model-based lab testing and real-world human data, we can get safe treatments to patients faster and more reliably while also reducing R&D costs and drug prices,” Makary said. “It’s a win-win for public health and ethics.”
Makary said the regulatory change creates a “more efficient pipeline for novel treatments” while improving drug safety because human-based tests make it easier to “predict real-world outcomes.”
The change also means the lives of thousands of animals, including dogs and primates, will be spared every year as the new testing methods are implemented, Makary added.
A range of testing approaches will replace the FDA’s prior animal testing requirement, including AI-based computer models of toxicity, cell lines and organ toxicity in labs.
The new testing requirements include using pre-existing and real-world data from other nations that have similar regulatory standards and already studied respective drugs in humans.
The new FDA testing standards allow for the use of computer modeling and AI to predict a drug’s behavior in humans.
The standards also allow for the use of lab-grown human organs and organ-on-a-chip systems that mimic human organs to test drug safety by revealing potentially toxic effects that otherwise would go undetected during animal-based testing.
Drug companies that use non-animal testing could receive accelerated reviews by the FDA to hasten the development of drugs and monoclonal antibody therapies without endangering patients.
Makary says the regulatory change positions the United States as a world leader in modern regulatory science that uses the latest technological advancements.
