About Kathryn Stein Consulting, LLC
Kathryn E. Stein, PhD, Principal
Dr. Kathryn Stein is an immunologist who has over 30 years of experience in biotechnology as a senior manager at the FDA and as an executive in industry. She is an expert in the field of polysaccharide-protein conjugate vaccines and monoclonal antibodies. During her 22 years at the FDA, the last 10 as the first Director of the Division of Monoclonal Antibodies, Dr. Stein was a leader in developing policies to regulate polysaccharide-protein conjugate vaccines, monoclonal antibodies and other recombinant DNA-derived products. She was lead or co-author on all of the guidance documents published by the FDA with respect to monoclonal antibodies and a co-author of the FDA guidance on comparability. She led the FDA efforts to develop guidance for plant-made pharmaceuticals and was responsible for bringing USDA into the process so that a joint FDA-USDA guidance document could be developed and issued (2002). Dr. Stein was one of the approving officials for the Haemophilus influenza type b (Hib) vaccines for routine use in infants. She was a member of the review committee of the first approved monoclonal antibody, OKT3™, and one of the approving officials for the subsequent 15 monoclonal antibodies approved through the first half of 2002. These products include abciximab, rituximab, palivizumab, trastuzumab, infliximab, and alemtuzumab. Dr. Stein received numerous awards for her review and policy work at the FDA. She was the 2014 recipient of the John and Samuel Bard Award in Medicine and Science from Bard College, Annandale-on-Hudson, NY.
In 2002, Dr. Stein left the FDA to join MacroGenics where she was responsible for establishing the Product Development and Regulatory Affairs, Project Management, Quality and Manufacturing departments. She served as Senior Vice President, Product Development and Regulatory Affairs until 2016. Under Dr. Stein’s leadership during her 14 year tenure, MacroGenics brought eight products into the clinic, seven of them newly developed by MacroGenics and one in-licensed as a phase 2/3 asset. MacroGenics manufactured all of those products in the GMP facility that Dr. Stein established.
After starting Kathryn Stein Consulting, LLC in 2012, Dr. Stein continued at MacroGenics as Senior Vice President, Product Development and Regulatory Affairs on a half-time basis until January 2016. She now devotes full time to her consulting work.
Since July, 2012, Dr. Stein has served as an Expert Consultant for NDA Partners. In 2016 she became a Director of Symbiotic Health (a privately held biotech company).
Dr. Stein received a BA in chemistry from Bard College and a PhD in microbiology and immunology from the Sue Golding Graduate Division of the Albert Einstein College of Medicine. Prior to joining the FDA, she was a post-doctoral Fellow at Harvard with Dr. Harvey Cantor and at NIH with Dr. William Paul. At FDA she was a Staff Fellow, Senior Investigator, and the first Director of the Division of Monoclonal Antibodies, Office of Therapeutics Research and Review, CBER, FDA. She maintained a research laboratory for her entire 22 year career at FDA and was a leading investigator in polysaccharide-protein conjugate vaccines. She has over 60 peer-reviewed publications.
A curriculum vitae will be provided on request.