Barry Cherney, PhD Amgen

Barry Cherney obtained a BA in Biology from the College of NJ and his Ph.D. in Biology from Case Western Reserve University in Cleveland, Ohio. He did postdoctoral training in the Department of Biochemistry and Molecular Biology at Georgetown University before joining CBER, FDA in 1991 as a Senior Staff Fellow in the Division of Hematological Products. During his 21 years in the FDA, Dr. Cherney held positions as Research/Reviewer, Full Time Reviewer, an Expert Biologist on comparability and served as FDA’s topic lead for ICH Q5E and as the committee chair for the draft document on Quality considerations for Biosimilar products. He was Deputy Director of the Division of Therapeutic Proteins for approximately 10 years where he was responsible for approval of CMC sections of license applications and supplements within his division. He served on CDER’s CMC governance committee and was an FDA spokesperson for QbD.  He joined Amgen Inc in 2012 as an Executive Director in product quality where he leads a team overseeing product quality for several of Amgen’s programs for legacy products and products under developments as well as Amgen’s Biosimilar portfolio.