Shannon F. Holmes, PhD, RAC Biogen Inc.

Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a team responsible for quality oversight and strategy of all products and devices in clinical development phases leading up to commercialization. Prior to this role, Shannon was a member of the Regulatory Affairs CMC team at Biogen and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. While at Biogen, Shannon has led successful submissions for clinical, licensed, and post-marketing regulatory applications for biological and combination products. Shannon has been an active member of the PhRMA ICH Coordinating Working Group, the BIO International Regulatory Committee, and the BPDG Regulatory CMC workstream. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.