Gary Kelloff, M.D.

National Cancer Institute

Dr. Kelloff is a special advisor for the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (NCI), where he has spent over 40 years in cancer research, authoring more than 400 publications.

At NCI, Dr. Kelloff developed a basic science, translational research and clinical development program in chemoprevention. Since 2001, he has worked on strategies for developing imaging-based and clinical biomarkers for oncology drug development and cancer patient management. He has led and currently leads several collaborations with the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry on drug development strategies, and co-chairs ongoing efforts under the 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 American Association of Cancer Researchers’ 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. 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.

Dr. Kelloff received his B.S. and his medical degree from the University of Colorado and completed post-graduate training in medicine at Emory University.