Michael Abernathy

Michael Abernathy, Associate Vice President, is currently leading Amgen’s internal Digital Innovation and End to End Regulatory Content Automation efforts. He is also co-developer of HL7 FHIR Product Quality International Standard (UV-pharm-quality https://build.fhir.org/ig/HL7/uv-dx-pq/) which was built to improve collaboration, content, and data exchange in the CMC domain. Previously, Michael led Amgen’s Global RA Chemistry, Manufacturing and Controls (CMC) function, accountable for more than 80 staff globally, and a product portfolio of over 85 programs. The extent of Michael’s product oversight and responsibilities traverse molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also founded Amgen’s RA CMC External Engagement function targeting activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. Michael has also been a consistent contributor to Accumulus Synergy’s cloud-based eco-system and digital data exchange efforts. Prior to his current post, Michael has held roles of increasing leadership at Amgen, including active contributions to several of Amgen’s commercialized therapeutics, as well as spearheading the company’s Analytics Optimization initiative. Michael has been an active contributor to innovation during his 25+ years as a Regulatory Affairs professional. Prior to joining Amgen, he held a leadership role within Atrix Laboratories/QLT, Inc.’s Regulatory Affairs group. Mr. Abernathy holds degrees from University of the Pacific, California State University and Colorado State University.