Steven Kozlowski M.D.


Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Quality, at the Center for Drugs Evaluation and Research (CDER), FDA. OBP is responsible for the quality assessment 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. Dr. Kozlowski joined the FDA in 1993 and he has been involved in all phases of the regulatory process, from pre-IND product development through inspections, licensing and post approval supplements. He is involved in ongoing policy development for biosimilars and advanced approaches for the manufacture of biopharmaceutical products.