PS17: Enhancing Artificial Intelligence and Machine Learning (AI/ML) in Clinical Drug Development: Advances and Opportunities from a Statistical Perspective

The rapidly evolving advancements of AI/ML has unveiled the potential to accelerate the process of drug development, from early discovery to late-phase clinical development. We have entered a revolutionary era with tremendous opportunities, including Increased data complexity, advanced technologies of collection of electronic data, improvement in computing environment, etc. While new technologies can facilitate the execution of AI/ML algorithms, statisticians should be in leadership positions to address research questions, hold accountability for model development and evaluation, coordinate interdisciplinary collaboration, and possess the capability to interpret results. The purpose of this session is to discuss the enhanced applications of AI/ML in biopharmaceutical and clinical research. The speakers from the industry will share their comprehensive understanding based on their extensive research experience of applying AI/ML in clinical development focusing on accelerating clinical development of medical products, optimizing trial design, and improving model efficiency. Specifically, speakers will present challenges of clinical drug development and provide some examples of data science applications, review the historical progression of AI in pharmaceutical research, and highlig how AI-driven methodologies are revolutionizing drug discovery and development processes. Discussants from academia and industry will share their statistical perspectives and insights into the AI/ML in clinical development.