Barbara Rellahan, PhD Amgen Inc.

Dr. Rellahan holds a MS in Cell Biology, a PhD in Immunology and performed a post-doctoral fellowship in the Laboratory of Immune Cell Biology, National Cancer Institute, NIH. Dr. Rellahan joined the Division of Monoclonal Antibodies (DMA), Office of Biotechnology Products (OBP), FDA in 1995. She began her career with the FDA as a research/review scientist, was converted to a Staff Scientist in 1998, and a Principle Investigator in 2004.  She subsequently became a Product Quality Team Leader in DMA and supervised a team of regulator scientists with responsibility for review of CMC sections of regulatory filings including assessment of product comparability, manufacturing and testing.   In 2013 she joined Amgen as a Director of Product Quality and manages a group of Product Quality Leaders who have product quality oversight of Amgen's biosimilar products including the establishment of specification, comparability and stability strategies.