Dr Marjorie Shapiro | Chief of Laboratory of Molecular and Developmental Immunology

Dr Marjorie Shapiro, Chief of Laboratory of Molecular and Developmental Immunology, CDER, FDA

Dr. Marjorie Shapiro received her Ph.D. in immunology in 1987 from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity.  Her current research continues towards understanding antibody repertoire development in natural and artificial systems and potential implications for therapeutic monoclonal antibodies.

She joined the Division of Monoclonal Antibodies in 1993.  After the reorganization of the Office of Biotechnology Products, she is currently Chief of the Laboratory for Molecular and Developmental Immunology in the Division of Biotechnology Regulation and Review I,  where she supervises regulation of novel and biosimilar monoclonal antibodies and Fc fusion proteins, as well as other therapeutic proteins.


EAC 2017 Day 1, Tuesday 31st October 2017 @ 17:50

FDA Update: Antibody therapeutics focusing on ADCs, bispecifics and cancer immunotherapies

  • An update on regulation from the FDA focusing ADCs, bispecifics, cancer immunotherapies
  • What do the new biosimilar developments mean in terms of regulation considerations?
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