Meeting Calendar

Upcoming events


4/26/2024  (on-site seminar)

Time: 1:30-2:45PM, March 31, 2023 

Location: Room E3609 Genome Cafe 

Lunch provided: lunch starts at 12:30pm

Youtube: Application of Artificial Intelligence & Machine Learning in Drug Development and Precision Medicine


Speaker: Ruihao Huang, FDA

Title:  Application of Artificial Intelligence and Machine Learning in Drug Development and Precision Medicine


[Abstract]  In this presentation, an overview will be provided on the regulatory submissions of drugs and biological products related to artificial intelligence and machine learning (AI/ML) in the U.S. Food and Drug Administration. The speaker will present three case studies where AI/ML was used during the Phase 2/3 drug development stage. Particularly, in the anakinra review, the FDA team utilized AI/ML to inform a regulatory decision. It was the first time the FDA used AI/ML to determine a suitable population for drug therapy. Besides the three regulatory submissions, the speaker will also discuss some ongoing AI/ML research projects related to the FDA’s mission.