2025-04-13XQuote

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Counter to rumors that it is in disarray, the FDA is changing regulations to help streamline the drug development process with #AI. In our view, some of the most profound applications of AI will be in health care.

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Big FDA news: as per ARK's Big Ideas, AI will play a huge role speeding therapies to patients. FDA said yesterday that animal testing will be phased out in favour of AI modelling & lab tests incl. organ-on-chips. We hope directionally this move will benefit humans and animals alike! https://t.co/81IxrjApRr These changes build on many years of consultation, and will be spearheaded with (monoclonal) antibody therapies. This choice may be in part because these tend to have high precision to their target and so are less liable to some of the side effects across the body that require animal studies to evaluate first. Ultimately, especially if this move helps unlock the troves of human trial data inside pharma companies and hospital systems, AI models may be able to support progression to human trials more rapidly than ever. Time to approval may drop to 8 years or less (instead of the traditional 13+ years to approval) which would be a massive driver of return-on-investment across drug development. https://t.co/pwKWzNt4Ss
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