Keith Watson
I hold a PhD in Biochemistry from Imperial College, London and have over 25 years of experience working with biological products in bio-pharmaceutical (CELLTRION, POLUS, ABBVIE), consultancy (PAREXEL), regulatory (MHRA), manufacturing (PROMETIC BIOSCIENCES, LONZA) and academic (ROYAL POSTGRADUATE MEDICAL SCHOOL, IMPERIAL COLLEGE) environments.
In my current role at CELLTRION, I have responsibility for the global regulatory strategy to support our extensive (more than 20) biosimilar monoclonal antibody pipeline. I am presently a member of the Medicines for Europe Biosimilars Sector Group.</p>
At POLUS, I was responsible for the development of an extensive microbial derived biosimilar pipeline with oversight of over 60 scientists and professionals across R&D and regulatory affairs.
<p>At ABBVIE, I was initially part of the Biologic Strategic Development Group, a global team who informed on biosimilar policy and development activities before moving into a European Regulatory Policy and Intelligence role for a variety of other policy areas. Whilst at ABBVIE, I was Chair of IFPMA BioT Working Group and a member of EUROPABIO and EFPIA working groups.
At PAREXEL, I was the European Practice lead for all Regulatory/CMC issues related to biological products, especially biosimilars and predominantly worked with CELLTRION supporting their biosimilar pipeline and the approval of the first monoclonal antibody biosimilar (infliximab, REMSIMA<sup>TM</sup>), in Europe.
At the MHRA, I was a Senior Quality Assessor in the Biologicals Unit reviewing CMC data for all types of biological products and was a Regular contributor to both UK and CHMP scientific advices as well as being a member of various CHMP guideline groups and working parties.
At PROMETIC BIOSCIENCES, I coordinated all Bioprocessing/Technical Support activities relating to affinity chromatography adsorbent development.
At LONZA, my role was a Senior Purification Scientist developing downstream purification processes for monoclonal antibodies for multiple clients and supporting transfer from bench to commercial scale.