Michael Abernathy

Placeholder Person Graphic
Amgen
Executive Director, Leads
Michael J. Abernathy, Executive Director, leads Amgen’s Global RA CMC function and is accountable for more than 65 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 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 is also a member of Accumlus Synergy’s executive leadership team, and is the Product Owner for the development of the company’s cloud-based Data Exchange Platform. Michael has been an active contributor to innovation during his 20-plus years as a regulatory affairs professional. He holds degrees from University of the Pacific, California State University, and Colorado State University.

Related Articles

Figure 1: Redundancies in the postapproval change management process contribute to delayed approval.
Features
Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...