Michael Pelekis, Ph.D., M.B.A.
Regulatory Affairs Manager
Michael Pelekis supports the interactions between the CTEP and the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiologic Health (CDRH) of the FDA. He helps to establish policy with the FDA for various aspects of the CTEP Investigational New Drug Applications (INDs), and assesses FDA and CTEP current policies to identify conflicts and propose solutions. He plays a critical role in facilitating the preclinical and clinical development of promising investigational anti-cancer agents. These agents include small molecules, cancer vaccines, monoclonal antibodies, recombinant DNA products, and other biologic and chemotherapeutic agents. He prepares, writes, organizes and submits INDs, Investigational Device Exemptions (IDEs) to the FDA for investigational anti-cancer and cancer diagnostic agents. Dr. Pelekis holds a Ph.D. in Public Health from the University of Montreal as well as a Master of Business Administration degree from Temple University.
About the Branch Chief
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…