Dr Marjorie Shapiro | Supervisory Biologist Office of Biotechnology Products

Dr Marjorie Shapiro, Supervisory Biologist Office of Biotechnology Products, 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.


Biosimilars Day 2 - Wednesday 30th October 2018 @ 09:30

Keynote: Tackling issues with submissions relating to Module 3 from FDA experiences, including but not limited to the analytical similarity section

  • Areas that have been problems across sponsors for 351k applications
  • TBC: FDA Guidance on statistics for the analytical similarity assessment
  • What pre-clinical and clinical data may be necessary to support a designation as an interchangeable biosimilar?
  • What is the impact of the interchangeable designation on US state pharmacy practice and what are potential solutions to these issues

Biosimilars Day 2 - Wednesday 30th October 2018 @ 11:25

Biosimilars: Current requirements and experience with EU and FDA approvals

Panel Discussion on regulation followed by questions from the audience
last published: 20/Jul/18 13:45 GMT
last published: 20/Jul/18 13:45 GMT

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