Gary Kelloff, M.D.

Advisor to Associate Director

Gary J. Kelloff, MD has had more than 40 years in cancer research at the National Cancer Institute (NCI), authoring more than 400 publications. Dr. Kelloff is a graduate of the University of Colorado (BS and MD degrees). After post-graduate training in medicine at Emory University, he began his NCI career as an intramural scientist and section head in viral immunology working on retroviruses and oncogenes. After fifteen years in NCI's intramural program, he developed a basic science, translational research, and clinical development program in cancer prevention, serving as a Branch Chief in the NCI Division of Cancer Prevention. Since 2001, he has been a special advisor to the Cancer Imaging Program in the NCI Division of Cancer Treatment and Diagnosis working on strategies for developing biomarkers for oncology drug development and cancer patient management. He previously led and currently leads several collaborations with FDA and the pharmaceutical industry on drug development strategies and since 2009 has co-chaired on-going efforts under the Foundation for the National Institutes for Health Biomarkers Consortium to create public-private partnerships to define biomarker use in cancer drug development and patient management. Past work has included establishment of a developmental pathway for approval of cancer prevention drugs as part of an AACR initiative and evaluation of tumor burden markers and precancerous histopathology as part of a C Change initiative. Current efforts under the Biomarkers Consortium include consideration of imaging-based biomarkers (FDG-PET/CT, volumetric CT, molecular probes) and new technologies for measuring circulating tumor cells and nucleic acids, minimal residual disease, novel trial designs for evaluating prognostic and predictive biomarkers, molecular signatures and new drugs, including gene expression and proteomic biomarkers, and evaluation of the tumor immune environment. He is also involved in on-going efforts to establish protocol and assay standardization for biomarker evaluation, as well as data-sharing for implementation in personalized medicine in oncology. Related to these efforts, Dr. Kelloff serves on the drug selection and oversight committees for two innovative clinical trials using biomarker-based designs to evaluate new oncology drugs (the I-SPY-2 trial in breast cancer and the Lung-MAP trial in non-small cell lung cancer). New tools for personalized medicine in oncology are evolving from these studies. All the work described has involved collaboration with stakeholders including leaders in industry, academia, FDA and other government agencies, foundations, and advocacy groups and has resulted in many publications addressing specific biomarkers and general drug development strategies.