PDUFA VII and Beyond: Building Confidence in AI Tools as New “Gold Standards” for Drug Development

Companies and regulators are turning to artificial intelligence and machine learning models across the entire life-cycle of product development, from drug discovery and clinical research to postmarket safety surveillance, to help make drug development more efficient and optimize real world patient outcomes. In early May 2023, FDA issued a discussion paper on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biologic Products requesting stakeholder feedback on how to best develop “standards for trustworthy AI that address specific performance in areas such as explainability, reliability, privacy, safety, security, and bias mitigation.” Please join us as our panel takes up the question of AL/ML standards in drug development and how we can move from high level principles to engineering standards by creating a collaborative test bed for AI/ML tools that allows for agile and effective regulation without deterring innovation in a rapidly evolving field.