Leveraging Artificial Intelligence in Drug and Biological Product Development: An FDA and Clinical Trial Transformation Initiative Workshop Report.
expert_opinion · Level V
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- Record sourced from PubMed, PMID 41383220.
- Also identified by DOI 10.1056/aipc2500801 and PMC identifier 12690500.
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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.