Anne Cook2

Dr Anne Cook

Expert Quality Assessor
UK Medicines & Healthcare products Regulatory Agency

Dr Anne Cook graduated from the University of Bristol with a BSc degree in Cellular Pathology. She studied for her postgraduate doctorate while working at Addenbrookes Hospital in Cambridge, UK, with an investigation into the antigens involved in an autoimmune blistering skin disease, bullous pemphigoid. She received her PhD from the University of Hertfordshire in 1988.

Dr Cook is an Expert Quality Assessor in the Biologicals and Biotechnology Unit at MHRA in the UK, where she has worked for over 13 years.  She has assessed new Marketing Authorisation Applications for several biotechnology products, from enzyme replacement therapies to biosimilar products, including several biosimilar monoclonal antibodies.  She also provides scientific advice to companies and academic groups who are developing biological products (including biosimilars). 

Dr Cook was an active member of the Biosimilar Guideline revision (Quality) working party at the European Medicines Agency and the revised guideline was published in 2014 (EMA/CHMP/BWP/247713/2012). She is currently a member of the National Biosimilar Medicines Programme Board, chaired by the Chief Pharmaceutical Officer, NHS England.

Dr Cook 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 direct practical experience in manufacturing and testing of biotechnology medicines, which has proved invaluable in her role as a biologicals quality assessor.