REdI 2024 | D2S05 - Artificial Intelligence/Machine Learning: The New Frontier of 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 ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367