Leveraging Artificial Intelligence in Drug and Biological Product Development: An FDA and Clinical Trial Transformation Initiative Workshop Report
Related Experiment Video
Updated: Jan 8, 2026

Introduction of an Integrated Pathology Image Management, Artificial Intelligence, and Reporting System
Published on: July 11, 2025
Atasi Poddar1, Marsha Samson1, Gabriel K Innes1
1Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Abstract:
Artificial intelligence (AI) holds immense potential to transform drug development by improving the efficiency and accuracy of key processes across the drug product life cycle. However, the scalable adoption of this technology may be influenced by new and unique challenges. The U.S. Food and Drug Administration collaborated with the Clinical Trial Transformation Initiative to organize a public workshop on Artificial Intelligence in Drug and Biological Product Development in August 2024 with medical product sponsors, technology innovators, academicians, and regulators to discuss guiding principles for the use of AI in drug and biological product development in order to realize its transformative potential. This article synthesizes key insights from the workshop and discusses the emerging current need for policy development to enhance the integration of AI in drug and biological product development.
Related Concept Videos
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
FDA Approved Drugs: Changes to Approved Drugs
Preclinical Development: Overview
Drug Discovery: Overview
Biopharmaceutical Factors Influencing Drug Product Design: Overview

