Kathryn Stein

Kathryn Stein is an accomplished scientist, regulatory official, and drug development executive. Dr. Stein was the first director of the FDA’s Division of Monoclonal Antibodies, where she led the development of regulatory policies for novel biotechnology products and approval of the early monoclonal antibody products. While at the FDA, she led a productive immunology research program developing bacterial products (polysaccharide-protein conjugate vaccines). From 2002 through January 2016, Kathryn served as Vice President and Senior Vice President of Product Development and Regulatory Affairs at MacroGenics, Inc., where she established product development and regulatory affairs, project management, quality, and manufacturing departments. She currently provides strategic advice and guidance for multiple therapeutics companies. She received a BA in chemistry from Bard College and a Ph.D. in microbiology and immunology from the Albert Einstein College of Medicine. She has received numerous awards for her long-standing achievements, including the FDA Center for Biologics Evaluation and Research Outstanding Service Award. She was the 2014 recipient of the John and Samuel Bard Award in Medicine and Science from Bard College.