Use of AI/ML to Support New Drug Development and Enhance Patient Care

This presentation intended to provide a summary from the regulatory publications on the use of AI/ML to support new drug development and patient care. In the presentation, I will share the general trend observed in the AI/ML related submissions to the CDER FDA, case examples from the FDA’s review and research projects, and future perspectives. Overall, we have witnessed an increasing trend on the use of AI/ML to support new drug development in the past a few years. The broadened usage of AI/ML may improve our capability to streamline new drug development and precision medicine. We have conducted multiple research projects with the attempt to understand patient heterogeneity in disease progression and response to treatment. I can share some review case examples on how AI/ML is applied to improve trial design and regulatory decision-making.