Kathryn Stein Consulting, LLC

Kathryn E. Stein, PhD, Principal

Website: KatyStein.com

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.   In 2002, she 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 serves as Senior Vice President Product Development and Regulatory Affairs and, since July 2012, continues at MacroGenics on a part-time basis and is the Principal, Kathryn Stein Consulting, LLC.