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U.S. National Institutes of Health
Last Updated: 07/16/13

About the Branch Chief

Jan Casadei, PhD

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 More…

Regulatory Affairs Branch (RAB)

The Regulatory Affairs Branch (RAB) is comprised of two groups, the Drug Regulatory Group and the Agreement Coordination Group. Responsibilities of each group include the following:

Drug Regulatory Group

  • Ensure that clinical studies are carried out according to FDA regulations and guidelines
  • Provide IND support for agents being developed by CTEP/DCTD, including preparation of initial IND submission followed by maintenance of active IND
  • Act as liaison between the FDA and NCI staff/NCI investigators/pharmaceutical collaborators, to facilitate investigational agent development
  • Provide regulatory advice to NCI intramural and extramural staff

Agreement Coordination Group

  • Foster pharmaceutical collaboration in evaluating promising investigational agents
  • Develop necessary agreements to support collaborative nonclinical and clinical studies; including CRADAs, CTAs, CSAs, and MTAs
  • Coordinate pharmaceutical collaborator interactions with NCI staff and investigators