Navigating the path to clinic for ATMPs: a regulator’s perspective

David McCall, Commissioning Editor, BioInsights, speaks to James McBlane, Preclinical Assessor in the Clinical Trials Unit, UK Medicines and Healthcare Products Regulatory Agency (MHRA)

James McBlane completed BSc and PhD degrees in pharmacology and worked for the drug company, Wellcome, before moving to the Medicines Control Agency and then to a Japanese biopharmaceutical company, where he worked for 10 years. He returned to work at the Medicines and Healthcare products Regulatory Agency (MHRA) in 2005 and had a role as an assessor split between the Clinical Trial Unit and also the unit for Biological Products, where he is now based. He has worked on thousands of clinical trials and hundreds of marketing authorization applications and given development advice to hundreds of companies. For 6 years from 2013, he was part of the European Medicines Agency’s Committee for Advanced Therapies (the CAT) and until early 2019, he was also part of the EMA’s Scientific Advice Working Party.

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