While the scientific barriers to drug development are a challenge, some wonder about the role AI will play in regulatory practices, especially when considering the future application of Big Data.

Stephanie Pasas-Farmer, Ph.D., BioData Solutions, LLC; Vikram Patal, JD, Ariadne Solutions; and Hao Zhu, Ph.D., U.S. Food and Drug Administration, explain how current technology is playing a role in the regulatory process, and how regulators may view these technology applications.

The session will address:

• The role of AI within regulatory sciences and submissions
• AI’s roles in quality standards and a regulatory framework
• An evidence-based strategy to maximize AI’s benefits when working with the FDA