The Clinical Trial Transformation Initiative (CTTI) and the FDA hosted a workshop on Artificial Intelligence in Drug & Biological Product Development focusing on innovations and best practices in clinical trials. The opening remarks from FDA’s Patrizia Cavazzoni, Director at CDER, included a reference that over 300 submissions have been made to the FDA with AI elements. She shared that the FDA is advancing AI Regulatory Science to focus on accelerating the adoption of AI models, encouraging early engagements with Model Informed Drug Development (MIDD). Cavazzoni indicated that clinical trials are at a turning point in drug development and using AI to optimize trial design and enrichment strategies and that data models must be “explainable” to generate high-quality evidence for submission. The goal is to create agile/inclusive clinical trials with clarity to foster innovation for submissions, and we need risk-based regulated approaches to create agile and inclusive clinical trials. There was further discussion about in silico trials during the event.