S4B – Statistical Synergy: Advancing Drug Development through Pharma-Academic-FDA Collaboration

Chair: Susan Halabi, PhD (Duke)

Abstract: In this session, leading statisticians from the pharmaceutical industry, academia, and regulatory agencies will come together to discuss how effective collaborations can accelerate drug development and improve patient outcomes. The panel will delve into innovative statistical methodologies and advanced tools that are transforming the landscape of clinical trials. Topics will include advancements in data integration, machine learning, and the application of generative AI to improve trial design, predictive modeling, and decision-making processes.

Special attention will be given to the opportunities generative AI presents in enhancing efficiency and accuracy while navigating the ethical considerations and regulatory implications associated with its adoption. The session will also emphasize the critical role of cross-disciplinary collaboration, highlighting the distinct and complementary perspectives that industry, academia, and regulatory agencies bring to the table.