Jan Casadei, PhD joined the National Cancer Institute in 1991, where she is now chief of the Regulatory Affairs Branch, CTEP. Her area of expertise covers FDA regulations, policies and guidelines for the conduct of clinical studies with investigational agents. As the chief of the Regulatory Affairs Branch, Dr. Casadei is responsible for facilitating the development of promising investigational anti-cancer agents, by providing regulatory/IND support and by coordinating the development of preclinical and clinical agreements with collaborators. Towards this end, she supervises a staff that files and manages a diverse and extensive IND portfolio and implements collaborative research and development agreements for these agents. Before coming to CTEP, Dr. Casadei spent 5 years in private industry developing bio- and electrochemi-luminescent probes as tools for high-sensitivity, nonradioactive immunoassays. Dr. Casadei received her undergraduate degree in biology from Barnard College, Columbia University, and a Ph.D. in biochemistry from the University of Pennsylvania.