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James McBlane PhD
Preclinical Assessor, Biologicals Unit
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
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Dr McBlane’s completed BSc and PhD degrees in pharmacology and worked in the research laboratories of the pharmaceutical firm, Wellcome, then moving to the Medicines Control Agency (MCA), where he worked in clinical drug safety, identifying potential new adverse drug reactions to medicines on the UK market. During this, he developed an interest in biological products and left the MCA to work for the Japanese biopharmaceutical company, Chugai. Over nearly 10 years, he worked in several different roles, including, finally, as Associate Director of Preclinical Development for the company in London. This experience included regulatory support for the first clinical trial with the drug that became tocilizumab, Roche’s RoActemra: he also worked on many other drugs that were notably less successful.
He returned to the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) in 2005 where he has been a preclinical assessor in the Biologicals Unit with a dual assessor role in the Clinical Trials Unit for over 9 years. During this time, he reviewed thousands of applications for clinical trials for all types of products and hundreds of marketing authorisation applications, mostly but not exclusively for biological products. On behalf of the MHRA, he has also contributed to several hundred meetings with companies to offer scientific advice on product development.
From 2013-2019, he was the alternate UK delegate to the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT); from January 2018, he was an alternate delegate from CAT to EMA’s Scientific Advice Working Party (SAWP). Both these roles stopped just prior to the UK leaving the European Union.
Since then, he has remained as a preclinical assessor in the Biologicals Unit. In this experience, he assessed applications for all covid-19 vaccines and antibodies to SARS CoV-2 where the company sought a licence from the MHRA. He has been the MHRA’s primary preclinical assessor at the licensing stage for all ATMPs since the inception of the CAT.
His primary interest is the question: what does the drug do? and allied to this, what is the evidence for this?