Andrew Lennard is in the Global Regulatory Affairs CMC team at Amgen and is based in the UK. Within CMC Regulatory Affairs, he is part of the External Engagement and Advocacy team with responsibilities in advancing innovations to accelerate CMC in product development. Andrew has over 20 years’ experience in CMC Regulatory Affairs, with a special interest in control strategy and using prior knowledge, in which he has participated at the EMA workshops on Prior Knowledge, and on CMC acceleration in Breakthrough/PRIME. He is also an active member of the European Trade Organisation, EFPIA, has led several initiatives relating to CMC acceleration, including ‘Stability’ for which he is the EFPIA topic lead on the Expert Working Group for the ICH Q1revision of the stability guidelines. Andrew has presented at numerous conferences and workshops on the development and use of predictive stability models for biologics, as well as to regulatory agencies. Prior to Regulatory Affairs CMC, he was a Principal Scientist in drug discovery for large pharma and small biotech start-up companies.
