Keith Chidwick, Ph.D

Keith Chidwick, Ph.D

Keith Chidwick, Ph.D

Vice President, Technical

Keith, VP Technical at Parexel, has a background in biochemistry research and the regulation of biotech medicines. He has developed a number of large scale bio-manufacturing processes and has been responsible for the technology transfer.

Work Experience

Keith has been closely involved in the funding of small biotechnology companies. Additionally he has assessed many biotechnology submissions as either Rapporteur or co-Rapporteur for the CMC/ quality section of the dossier. Keith was a project scientist at Bio products Laboratories, developing manufacturing methods for plasma products. He went on to work for a consulting/venture capital fund advising on the technical issues of investment in small biotechnology companies. This involved performing technical and commercial due diligence of potential investments. At the MHRA he served as a Senior Pharmaceutical Assessor and was later appointed Deputy Manager of the Biologicals Unit. During this time he reviewed, as the Rapporteur/ Co-Rapporteur, the Quality Assessment 18 MAAs via the Centralized Procedure including monoclonal antibodies, biosimilar applications, QbD antibody applications, recombinant proteins, vaccines and plasma products. Keith was also Rapporteur for over 60 EMA Formal Scientific Advisories covering a number of topics for biosimilars, QbD, mAb manufacturing changes, process validation, gene transfer, drug/device combinations, comparability, ATMPs and many others. For 8 years he fulfilled the role of UK expert at EDQM P4 BIO and has been a member of EMA Guideline Drafting groups. He was also a member of the Control Board at NIBSC.

Education

Keith has a BSc and PhD in biochemistry from the University of London as well as an MBA. He has had five years’ experience as a research fellow at the London Hospital Medical School working in the area of inflammation. Additionally, he was a Senior Lecturer in biochemistry at the University of Westminster.

We are always available for a conversation.

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