Steven Bowen Ph.D. Eliquent Life Sciences

Steven Bowen Ph.D. is a former Investigator and Director of FDA’s Team Biologics in what is now the Office of Inspections and Investigations (OII) where he participated in and oversaw inspections and compliance activities for CBER-regulated biologic drugs including vaccines, cell and gene therapies, and human plasma derivatives. He also spent 5 years in CDER’s Office of Biotechnology Products as a CMC reviewer and Team Leader, managing the review of CMC information in IND and BLA applications including the development and validation of manufacturing processes and analytical methods for recombinant proteins and monoclonal antibodies. Steven has a Ph.D. in Molecular Microbiology and Immunology and was a postdoctoral fellow at the National Cancer Institute in Bethesda, MD before joining the FDA in 2014. He is currently a Principal Consultant at Eliquent Life Sciences, advising clients on CMC strategy and GMP compliance for biologics.