Anne Cook | Biologicals Quality Assessor

Anne Cook, Biologicals Quality Assessor, M.H.R.A.

Anne is a Senior Quality Assessor in the Biologicals and Biotechnology Unit at MHRA (Medicines and Healthcare products Regulatory Agency) in the UK, where she has worked for over 12 years.  She has assessed new Marketing Authorisation Applications for several biotechnology products, from enzyme replacement therapies to biosimilar products, including a number of biosimilar monoclonal antibodies.  She also provides scientific advice to Companies and academic groups who are developing biosimilar products. Anne was an active member of the Biosimilar Guideline revision (Quality) working party at the European Medicines Agency. The revised guideline was published in 2014 (EMA/CHMP/BWP/247713/2012).
Anne previously worked at British Biotech Pharmaceuticals Ltd. in Oxford, where her career took her from research in protein biotherapeutics into product development and manufacturing of a recombinant glycoprotein product for Phase II clinical trials. This provided practical experience in manufacturing and testing of biotechnology medicines, which has proved invaluable for assessment of biosimilar medicines, in collaboration with other Member States at EMA.


Biosimilars Day 2 - Wednesday 1st November 2017 @ 09:30

CMC Strategy: A critical foundation for biosimilars

  • Revision of Quality guidance for biosimilars (CHMP/BWP/247713/2012)
  • Development considerations before clinical trials
  • Critical quality attributes and mechanism of action

Biosimilars Day 2 - Wednesday 1st November 2017 @ 09:55

Panel Discussion on regulation and IP followed by questions from the audience

  • European Regulators positions on interchangeability and public study results as an introduction to the debate on how best to share and communicate real world evidence and pharmacovigilance data.
  • What are the most appropriate means and platforms which could reduce the gap between regulatory science and medical practice and which could inspire others to follow?

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