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Last Updated: 10/19/15

Massimo Cardinali, M.D.

Massimo Cardinali

Senior Regulatory Affairs Manager

Massimo Cardinali, M.D. joined the Drug Regulatory Group in the Regulatory Affairs Branch in 2014. Dr. Cardinali graduated from the Medical School of the University of Pisa, Italy, in 1984. In 1986, after completing his residency in the Nuclear Medicine Department of the University of Pisa, he moved to NIH to conduct basic research in Oncology. Dr. Cardinali has nearly 20 years of experience in clinical research having worked as a Medical Officer in the Oncology Branch at CBER, FDA, and in the Vaccine Research Branch at the Division of AIDS (DAIDS), NIAID, NIH. Prior to coming to NCI, Dr. Cardinali also served as a Senior Regulatory Manager in the Regulatory Affairs Branch at DAIDS. Dr. Cardinali provides regulatory support and IND management for a portfolio of NCI-sponsored clinical protocols; provides regulatory advice for other members of CTEP; and facilitates communications with the FDA.

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…