As an Executive Director, Regulatory Affairs, Mr. Abernathy leads Amgen’s Global RA CMC function and is accountable for 40 staff, and a product portfolio of over 50 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 leads Amgen’s advocacy and external engagement activities that comprise a CMC focus, including, promoting company and industry initiatives, engaging with Health Authorities around the globe and contributing to industry organizations. Prior to his current post, Michael has held roles of increasing leadership at Amgen, including active contributions to several of Amgen’s approved and commercialized therapeutics, as well as spearheading the company’s Analytics Optimization initiative.
Michael has been an active contributor to innovation during his 20 years as a Regulatory Affairs professional, thirteen of which have been spent at Amgen. Prior to joining Amgen, he held a leadership role within Atrix Laboratories/QLT, Inc.’s Regulatory Affairs group. Michael began his career in the biotechnology industry as a Regulatory Specialist at the blood plasma-based company, Alpha Therapeutics (Grifols S.A.).
Mr. Abernathy earned Bachelor’s degrees in Sports Medicine from University of the Pacific and Human Physiology from California State University. Michael received his Graduate Degree in Cellular and Molecular Biology. He is currently a member of the Regulatory Affairs Professional Society and was Regulatory Affairs Certified (RAC) in April 2004.