Artificial intelligence (AI) is increasingly being applied across drug and biological product development, creating new opportunities to support therapeutic discovery, clinical trial design, and regulatory decision-making. At the same time, questions remain about how to ensure AI is used responsibly, transparently, and in ways that support patient safety and public trust.

To explore these opportunities and challenges, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), convened the second annual public workshop on Artificial Intelligence in Drug and Biological Product Development in 2025. The workshop brought together experts from across sectors to discuss current and emerging applications of AI, practical implementation challenges, and considerations for the future.

A new summary, Artificial Intelligence in Drug Development: Use Cases, Challenges, and Future Considerations, captures key themes and insights from the workshop discussions.

The summary highlights topics including best practices, cross-disciplinary collaboration, approaches to improving data quality and transparency, and considerations for responsible applications of AI in clinical research and regulatory decision-making.

Read the summary to explore key insights and future considerations from the workshop.