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 from the University of  Pennsylvania where she studied molecular mechanisms underlying antibody diversity.  She has over 25 years experience regulating CMC for monoclonal antibodies and related products, including antibody-drug conjugates, bispecific antibodies, antibody cocktails, Fc-fusion proteins, and biosimilar products.


European Antibody Congress 2018, Day 1 @ 14:30

An FDA perspective on the implementation of state-of-the-art analytical methods and understanding structure-function relationships

  • Evolution of the analytical tool box
  • Implementation of state of the art methods and FDA expectations
  • Evolution of understanding mAb structure-function relationships and FDA expectations

European Antibody Congress 2018, Day 1 @ 15:10

Extended regulatory Q&A

  • The floor will be opened to an extended Q&A session for our regulatory speakers
  • The session will be moderated byMarjorie Shapiro, Supervisory BiologistOffice of Biotechnology Products, CDER, FDA
last published: 16/Oct/18 13:05 GMT

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There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.

Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October 

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