SESSION G

Artificial intelligence (AI) is rapidly transforming drug discovery and development, creating unprecedented opportunities to improve efficiency, accelerate evidence generation, and enhance decision-making across the product lifecycle. At the same time, widespread adoption of AI introduces important scientific, regulatory, and governance considerations that must be addressed to ensure trustworthy and responsible use.

This three-hour session brings together leaders from industry, academia, and regulatory science to examine both the promises and challenges of AI implementation in biopharmaceutical research and development. The session will begin with an overview of the ASA BIOP section AI-NEXUS initiative, (led by Dr Judy Li AstraZeneca), highlighting findings from recent landscape assessments, industry surveys, emerging regulatory guidance, and key insights from recent professional discussions. Dr Jianchang Lin and Dr Tarek Hammad (Takeda) will then present their award-winning work on digital twins (2026 RSS Statistical Excellence Award Announcement) and on AI for safety evaluation. These examples will illustrate how AI-enabled approaches can support decision-making while emphasizing the importance of causal reasoning, transparency, validation, and human oversight.

The session will conclude with an interactive panel discussion on scalable AI adoption, regulatory expectations, workforce development, and the future role of statisticians and data scientists in an AI-driven environment. Attendees will gain practical perspectives and actionable principles for implementing AI responsibly to support high-quality scientific and regulatory decisions throughout drug development.

Instructors’ Biography:

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field.

Jianchang Lin is Interim Head Statistical and Quantitative Sciences in Takeda Pharmaceuticals with extensive drug development experience across various therapeutic areas in oncology, cell therapy, immunology and rare disease including several successful global approvals and access in US, EU, Japan and China. He has published over 70 papers in statistical and clinical peer-reviewed journals/book chapters and served as editors for two books published in Springer with research interests in innovative trial designs, quantitative decision making, RWD/RWE and advanced data science. He is also an Associate Editor of Journal of Biopharmaceutical Statistics and currently serving as program chair elect for ASA Biopharmaceutical section, Industry Co-chair for 2024 Regulatory-Industry Statistics Workshop, etc.

Dr. Judy Li, PhD, is the Head of Hematology Strategy Late Oncology Statistics at AstraZeneca, where she provides leadership and expertise in oncology statistics, with a keen focus on strategic planning, technical oversight, functional development, and operational guidance. Throughout her career, Dr. Li has held senior leadership positions in both the biopharmaceutical and biotech sectors, making significant contributions at organizations including Bristol Myers Squibb, Celgene, and Regeneron Pharmaceuticals. Prior to her industry tenure, she garnered extensive experience at the US Food and Drug Administration as a master statistical reviewer and supervisory mathematical statistician. Her clinical development experience across multiple therapeutic areas including oncology, hematology, immunology, neurology, cell therapy, as well as special clinical settings for multiregional clinical trials and rare disease.

As an active member of the American Statistical Association (ASA) Biopharmaceutical Section Executive Board for more than a decade, Dr. Li has taken on multiple responsibilities and roles within the board. She is currently Biopharmaceutical Section chair-elect for 2026, was the co-founder of the Safety Monitor Scientific Working Group, the chair of 2019 Regulatory Industry Statistics Workshop, the chair of poster competition section and membership committee.

Dr. Li received her PhD in Statistics from the University of California, Riverside and her MBA degree majored in Strategic Management from the Wharton Business School University of Pennsylvania. She is the editor of book Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation. Her research work has been highly acknowledged with the