Andrew C. Lennard, PhD

Amgen Ltd
External Engagement and Advocacy
Andrew C. Lennard, PhD, is in Amgen’s External Engagement and Advocacy team within CMC Regulatory Affairs. Prior to joining Amgen, he was a consultant in CMC regulatory affairs. He has 15+ years of CMC regulatory experience mostly focused on the EU for clinical trials, marketing applications, and post-approval variations. Before moving to regulatory affairs, he held drug discovery principal scientist positions in pharma and biotech companies. Andrew has a PhD in biochemistry from Cambridge University and is interested in applying prior knowledge and science- and risk-based control strategies to biological medicinal products with a focus on product stability, as well as the introduction of new technologies to accelerate the design, manufacture, and control of biopharmaceuticals. He represents Amgen in many EFPIA IQ Consortium and BIO Trade Organisations’ workstreams while being the EFPIA topic lead on the ICH Expert Working Group for the ICH Q1/Q5C revision.

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A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...