Andrew C. Lennard, PhD Amgen

Andrew Lennard is in the global regulatory affairs CMC team at Amgen, based in Uxbridge (UK). Within CMC regulatory affairs, he is part of the External Engagement and Advocacy team with responsibilities in advancing approaches to accelerate CMC in product development. Andrew has over 15 years’ experience in marketing applications, clinical trials and variations/amendments for both biologic, synthetic molecules and drug/device combination products, with a special interest in control strategy and integral drug-device combination products. Andrew participated at the EMA workshops on Prior Knowledge and on CMC acceleration in Breakthrough/PRIME. He is also an active member of EFPIA leading several initiatives relating to CMC acceleration, including 'Stability' in which he is the EFPIA topic lead expert in the forthcoming ICH revision of the stability guidelines. Prior to Amgen, Andrew trained in Regulatory Affairs at ERA Consulting and previously held Principal Scientist positions in drug discovery for Pharma and Biotech spanning 12 years of ‘bench science’; and post-doctoral positions in molecular biology for LGME, INSERM (Strasbourg) and Cancer Research UK (London). Andrew is an active member of EFPIA-MQEG CMC and Biomanufacturing Workstreams and holds a PhD in biochemistry from the University of Cambridge