FDA Modernization Act 2.0 Paves the Way to Computational Biology and Clinical Trials in a Dish

Syed Mukhtar Ahmed , PhD; Rabindra V. Shivnaraine , PhD; Joseph C. Wu , MD, PhD

For nearly a century, animal testing was the sole method for assessing drug safety and efficacy before advancing to human clinical trials. However, with the historically low success rate of just 9.6% for drugs entering phase I clinical trials, there’s a noticeable gap in the accuracy of animal-based tests predicting human responses. To address this, the FDA Modernization Act 2.0, passed in late 2022, paves the way for incorporating advanced non-animal testing methods into the drug approval process. This act endorses cutting-edge alternatives like cell-based approaches (e.g., human induced pluripotent stem cells, organoids), microphysiologic systems, and computer-driven methodologies, such as AI and machine learning. These innovative methods, like the “clinical trials in a dish,” aim to better replicate human variability, making drug testing more predictive of human outcomes and potentially improving the drug approval success rate.

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