Why A Formally Trained Pediatrician Decided To Join the FDA

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

From The October 2015 Issue
Read the full magazine article: More Than The Rise In Biologics Prompts Reorg At FDA

“My professional training is as a pediatrician,” says the FDA’s director of the Office of Biotechnology Products, Steven Kozlowski, M.D. The subject of the October 2015 Life Science Leader magazine cover feature, More Than The Rise In Biologics Prompts Reorg At FDA, shares why he decided that instead of practicing as a physician, opted to join the FDA. “In 1993 I completed an immunology fellowship in research at the NIH. My goal was to find a career that linked immunology and patient benefit. The Division of Monoclonal Antibodies at the FDA had an opportunity that allowed for both the regulation of therapeutic antibodies and the laboratory study of immunology related antibody targets and biological assays. Taking that opportunity allowed me to witness the rapid growth of monoclonal antibody products. This facilitated a broad perspective of how effective use of a new technology depends on the comaturation of industry and quality systems. A parallel lesson that took longer to learn is that the effective use of advances in science and risk evaluation in regulation depends on the comaturation of people, processes, and organizational structures.”