Michael Abernathy

Michael Abernathy, leads Amgen’s Global RA Chemistry, Manufacturing and Controls (CMC) function. 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. He is currently leading Amgen’s regulatory digitalization initiative, and he is also co-developer of HL7 FHIR Product Quality International Standard (UV-pharm-quality https://build.fhir.org/ig/HL7/uv-dx-pq/).