REdI 2024: AI & ML in Drug Development 🚀

This presentation introduced background information on artificial intelligence and machine learning in pharmaceutical development and described the current landscape of AI/ML-related submissions and reviews at CDER. The session listed key challenges associated with AI/ML applications and discussed evolving regulatory considerations for these technologies. AI/ML-related activities within the Office of Clinical Pharmacology were highlighted to demonstrate the agency's comprehensive approach to integrating these emerging technologies into drug development and regulation.

Timestamps

02:55 – AI/ML and Related terminology

04:48 – Important Types of Neural Networks

07:27 – Opportunities for the Application of AI/ML in Drug discovery, Drug Development and Patient Care

12:25 – Regulatory Considerations for AI/ML in Drug Development (Personal Opinion, Still Evolving)

14:37 – Review Examples

22:08 – Challenges in the Application of AI/ML

25:30 – AI/ML Activities in Office of Clinical Pharmacology (OCP)/FDA

29:30 – Questions

Speaker:

Qi Liu, PhD, MStat, FCP
Associate Director for Innovation & Partnership
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
Center for drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development

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