Keynote 1 - Thursday, April 9, 2026
Chair: Wanjie Sun, PhD (FDA)
Title: Evolving Role of Statisticians in the Artificial Intelligence and Digital Health Era
Presenter:
Mark Levenson, PhD
Office of Biostatistics
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)
Keynote Abstract:
Like all segments of industry and science, Artificial Intelligence (AI) and digital technologies are greatly impacting medical product development. The number of submissions to the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration that leverages AI is rapidly increasing. AI has roles in all phases of development, including discovery, non-clinical and clinical research, pharmacovigilance, and manufacturing. In addition to the great potential, there are unique challenges and risks to these technologies. FDA has draft guidance that addresses considerations for AI use in regulatory decision making.
Dr. Mark Levenson is currently the Acting Office Director of the Office of Biostatistics at the Center for Drug Evaluation at the U.S. Food and Drug Administration. He has led many major pre-market and post-market statistical reviews, leading to approvals of novel drugs and to important safety warnings. He contributes to statistical policy and guidance development in the areas of regulatory evidence and real-world evidence. He is a member of the CDER Medical Policy and Program Review Council, the FDA Real-World Evidence Committee, the CBER-CDER Rare Disease Policy and Portfolio Council, and the Office of Biostatistics Statistical Policy Council. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago, a B.A. in Mathematics from Cornell University, and graduated from the Bronx High School of Science. Mark is an elected fellow of the American Statistical Association.
Keynote 2 - Friday, April 10, 2026
Chair: Fang Chen, PhD (SAS Institute, Inc.)
Title: From Insight to Impact: Agentic AI and the Decision Architecture of Trustworthy Action
Presenter:
Udo Sglavo
Vice President
Applied Artificial Intelligence and Modeling Research and Development
SAS Institute, Inc.
Keynote Abstract:
As AI systems move from generating insights to executing decisions, the central challenge facing organizations is no longer model accuracy alone, but decision quality at scale. When models act, inference becomes operational. This keynote examines how the rise of agentic AI changes the role of statistics, shifting emphasis from insight generation to the design of decision systems that are trustworthy, explainable, and accountable.
Building on recent domain-specific advances in areas such as clinical research and public health, the talk introduces decisioning as the missing architecture that connects statistical rigor to real-world impact. Decisioning defines how model outputs are translated into actions through evidence, constraints, human oversight, and continuous validation. Using illustrative examples across multiple industries, the keynote highlights where statisticians play a critical role as decision architects, shaping uncertainty thresholds, escalation logic, auditability, and long-term monitoring.
The session reframes agentic AI as a decision-system problem rather than a modeling problem, and argues that the future impact of AI depends on how effectively statistical principles are embedded into the systems that act on our behalf.
Udo Sglavo leads Applied Artificial Intelligence and Modeling Research and Development at SAS. With a 25-year track record of fostering technology innovation and excellence, Udo heads a team of expert developers and data scientists dedicated to pioneering cutting-edge software and leveraging advanced models to transform the way the world works.
By imagining and building the next generation of AI-driven models and software solutions, Udo helps organizations harness the power of data and analytics to solve their toughest business challenges and outpace the world around them.
Udo’s commitment to pushing the boundaries of what AI can achieve has earned him recognition as a global thought leader shaping the future of technology. In addition, Udo has written three publications and holds four patents in advanced analytics.
