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AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment
Session Chair(s)
Hillary Andrews
Senior Director, Science Policy & Strategy
Friends of Cancer Research, United States
AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities, risks, regulatory oversight, and the role of reference datasets for tool validation.
Learning Objective : Describe the current landscape and practical applications of AI-based diagnostic tools; Examine potential regulatory frameworks and strategies to ensure oversight and reliability of AI-based diagnostics; Identify key considerations in developing reference datasets to support validation of AI tools.
Speaker(s)
Patient Advocate Perspective
Jason Binder
Patient Advocate, United States
Industry Perspective
Mike Montalto, PHD
Amgen, United States
Industry Perspective
Alain Silk, PHD
Tempus AI, Inc., United States
Senior Director, Regulatory Affairs
FDA Perspective
Representative Invited
FDA, United States
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