NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Kathryn E Stein, PhD

Practice Area Focus

  • Biologics
  • Biosimilars
  • Monoclonal Antibodies
  • Regulatory Strategy
  • Development Strategy


Kathryn Stein, PhD, is a former Director of the Division of Monoclonal Antibodies at the US Food & Drug Administration (FDA). During her tenure at the agency, she 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, Dr. Stein left the FDA to join MacroGenics, Inc where she was the Senior Vice President for Product Development and Regulatory Affairs and was responsible for establishing the Product Development and Regulatory Affairs, Project Management, Quality and Manufacturing departments. In 2016 she became a full-time consultant. She has published over 60 peer-reviewed publications.