Session: Symposium: Harnessing The Power of AI/ML in Drug Development
The Use of Machine Learning in the Development of Scoring Rule for the Identification of Adult Patients Under the Emergency Use Authorization for Anakinra for Treatment of COVID-19 in the United States
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 between 2016 and 2022. Particularly, the speaker will delve into a recent case where US FDA utilized AI/ML to inform a regulatory decision related to patient selection for a drug therapy.
Learning Objectives:
Summarize the landscape of AI/ML application in regulatory submissions for drug development
Describe a recent case where US FDA utilized AI/ML to inform a regulatory decision related to patient selection for a drug therapy
Discuss the considerations during the development of scoring rule for the identification of patients
.jpg "Ruihao Huang, PhD (he/him/his) photo")