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Process development and CMC, supporting regulatory approvals

Dr Mike Ashwood, B.Sc, PhD, CChem, MRSC, has over 30 years’ experience within the pharmaceutical industry, working in both biotech and large multi-national pharma organisations. Up until 2008, he held positions of increasing responsibility at the world-renowned Process Research Department of Merck &Co, New Jersey, USA, and from 2010 until 2020 he was responsible for all API deliveries at Proximagen Ltd, subsequently Benevolent AI, managing many GMP campaigns delivering up to 100 kg of API for Phase II clinical trials.  At both Merck & Co and Proximagen his responsibilities included route selection, route optimisation and hazard evaluation (OHE) to ensure that all API deliveries were managed according to current legislation and were environmentally benign.  Whilst at Merck & Co. he managed the GMP API delivery of sixteen different clinical candidates in a three-year period from a state-of-the-art pilot plant.  Dr Ashwood has many years of experience managing process development programmes and has a broad technical and quality understanding of chemistry, manufacture and controls (CMC) and the associated regulatory operations.  At BenevolentAI, Dr Ashwood was responsible for CMC activities for all the clinical assets and supported due diligence activities for out-licensing opportunities.  Dr Ashwood has experience of Clinical Trial Applications, writing the drug substance section for many IMPDs and co-authoring the drug product section for the majority of those.  Dr Ashwood is a senior or co-author on over 20 peer-reviewed publications and is co-inventor on over 20 patents. He received his B.Sc in Chemistry from the University of Exeter, and a Ph.D in Organic Chemistry from the University of London.

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