Steven
Kozlowski
M.D.
Leadership Role
Acting
Chief Scientist - Office of the Chief Scientist
Steven Kozlowski, M.D., is the FDA’s Acting Chief Scientist. The Chief Scientist promotes, leverages, and leads cross-cutting, collaborative activities and initiatives that catalyze FDA science, innovation, and research to help the agency address its most pressing regulatory and public health questions and respond to emerging issues. The Office of the Chief Scientist supports the research foundation, science, and innovation that underpins the FDA’s regulatory mission. It does this through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy and decision-making, the professional development of regulatory scientists, and conducting applied research and testing at the FDA, including in its National Center for Toxicological Research, Office of Analytical and Regulatory Laboratories, and Office of Specialty Laboratories and Enforcement Support.
Dr. Kozlowski brings extensive scientific, regulatory and management experience to the Office of the Chief Scientist, including a breadth of knowledge in pharmaceutical quality, immunology and research.
Prior to assuming the role of Acting Chief Scientist, Dr. Kozlowski served as Director of the Office of Product Quality Assessment III (OPQA III) in the Office of Pharmaceutical Quality (OPQ) in the FDA’s Center for Drug Evaluation and Research (CDER). In that role he led a team responsible for ensuring the quality of all the active ingredients and substances in products overseen by CDER, which includes everything from over-the-counter analgesics to complex biological products. QPQA III was created as part of a major reorganization of the Office of Product Quality, an important initiative designed to support greater agility, connectedness and influence. Dr. Kozlowski was part of the strategic planning and change management involved in that effort.
Prior to the OPQ reorganization, Dr. Kozlowski served for 18 years as the Director of the Office of Biotechnology Products (OBP) in CDER’s Office of Pharmaceutical Quality, overseeing the quality of therapeutic biological products and a laboratory program with research in manufacturing science, immunology and bioassays. His tenure coincided with a phenomenal growth in the use and impact of biological products, including the development of a new regulatory pathway for biosimilar biological products.
Dr. Kozlowski holds a bachelor’s in science from Northwestern University, as well as a Doctor of Medicine with distinction from their Medical School. He trained in pediatrics at the University of Illinois. He has published extensively in a wide range of scientific areas relevant to the FDA mission from in vivo models for drug development to vaccine safety and from biosimilar uptake to epidemiology.