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FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first Letter of Intent (LOI) for an in silico drug development tool (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program.
The DDT is an artificial intelligence (AI)-Driven Digital Liver Model for Prediction of Drug-Induced Liver Injury (DILI). It aligns with FDA's vision of optimizing drug development and evaluation while minimizing the use of animals in the nonclinical space, potentially expediting the availability of safe and effective treatments. As a New Approach Methodology (NAM), the DDT will work to improve predictive toxicology in humans, and aligns with CDER’s long-standing interest and investment in implementing the 3Rs (replacement, reduction, and refinement) of animal testing in drug development. It will help predict DILI by leveraging AI to compare the chemical structures of new drug candidates against historical reference drugs with known DILI risk. The model predictions will aim to complement other methods of DILI risk assessment as part of a weight-of-evidence approach.
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