Gary Kelloff, M.D.

Cancer Imaging Program
National Cancer Institute (NCI)

Gary J. Kelloff, MD has had over 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 moved to what is now the Division of Cancer Prevention (DCP), where he developed a basic science, translational research, and clinical development program in chemoprevention. Since 2001, he has been a special advisor for the NCI Division of Cancer Treatment and Diagnosis working on strategies for developing imaging-based and clinical 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 co-chairs on-going efforts under NCI/FDA Intra-agency Oncology Task Force (IOTF) and the Foundation for the National Institutes for Health Biomarkers Consortium (BC) 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 (PSA-doubling time prostate cancer, Ca-125 in ovary) and precancerous histopathology (colorectal adenomas) as part of a C-Change initiative. Current efforts under the NCI/FDA IOTF and BC include consideration of functional and molecular imaging (FDG-PET/CT, DCE-MRI, volumetric CT, molecular probes) and new technologies for measuring circulating tumor cells, minimal residual disease, novel trial designs for evaluating prognostic and predictive biomarkers, molecular signatures and new drugs, including gene expression and proteomic biomarkers. All this work has involved collaboration with leaders in industry, academia, and the pharmaceutical industry and has resulted in many publications addressing specific biomarkers and general drug development strategies.