Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development v2

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Recruitment, Regulatory Submissions + Approvals, Safety, Site Planning
SHARE TO:
The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development.
During the workshop, we learned from experts as they discussed guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts discussed their rationale for particular approaches, shared their methods for evaluating success, recounted challenges and obstacles, explored options for scaling and wider applicability, and outlined considerations for moving forward. Presentations can also be found here.
Recent News Feed
- CTTI Publication Provides Recommendations for Disease Progression Modeling in Medical Product Development August 6, 2026

- New Resource Highlights Key Insights from the FDA/CTTI Workshop on Artificial Intelligence in Drug and Biological Product Development July 13, 2026

- CTTI Releases Executive Summary from Patient Summit June 17, 2026
