Keynote Speakers

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  FDA has draft guidance that addresses considerations for AI use in regulatory decision making.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.