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U.S. National Institutes of Health
Last Updated: 10/19/15

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.