Steven Kozlowski

Company: FDA

Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research (CDER), FDA. OBP is responsible for the quality review of monoclonal antibodies and most therapeutic proteins at CDER. OBP also provides expertise on immunologic responses to therapeutic proteins and performs mission related research. Dr. Kozlowski received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship. Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as a Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing and post approval supplements. Dr. Kozlowski served as the acting Director of the Division of Monoclonal Antibodies from 2004-2005. He has also served as an instructor and as an adjunct clinical reviewer at FDA. Dr. Kozlowski’s research interests include the effects of drugs on the immune system. He is involved in ongoing policy development for biosimilars and Quality-by-Design approaches for the manufacture of biopharmaceutical products.