Anne Cook

Company: MHRA

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 9 years. She has assessed new Marketing Authorisation Applications and variations for a number of biotechnology products, from enzyme replacement therapies to biosimilar products. Her work also involves evaluation of blood products, vaccines and allergy products within the Biologicals Unit. She is a member of the Biosimilar Quality Guideline revision working party at the European Medicines Agency.

Anne previously worked in the pharmaceutical industry and did academic research for several years, where she gained relevant experience. She spent 15 years at British Biotechology in Oxford, where her career took her from research in protein biotherapeutics into product development and finally manufacturing of a recombinant glycoprotein product for Phase II clinical trials.