PS07: Revolutionizing Clinical Development with AI and ML: Diverse Applications and Innovations

The rapid evolution of Artificial Intelligence (AI) and Machine Learning (ML) has unlocked unprecedented opportunities in clinical development, fundamentally reshaping how innovative treatments are developed. This session will explore the diverse applications of AI and ML in enhancing clinical development processes, focusing on its ability to accelerate drug clinical development, optimize trial design, improve trial monitoring, and ensure compliance with regulatory standards. By presenting unique perspectives from both industry experts and the FDA, this session will offer attendees actionable insights into the transformative role of AI in this space. While AI/ML's potential in clinical development has been discussed at prior conferences, this session offers a fresh and forward-looking perspective by emphasizing underexplored applications, including generative AI and novel statistical methodologies, alongside regulatory considerations. The speakers will share case studies and practical examples, providing attendees with insights that go beyond theoretical discussions. This session is particularly relevant now as the integration of AI/ML tools in clinical development rapidly evolves, creating an urgent need to bridge technical innovation with regulatory frameworks and practical implementation strategies.