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Date: February 7, 2012
Time: 6:00 PM - 7:30 PM
Speaker(s):
Chaitanya Divgi, MD, Director of PET/Nuclear Medicine and Vice-Chair, Research, Department of Radiology, Columbia University
Location: The New York Academy of Medicine, 1216 Fifth Avenue at 103rd Street, New York, NY 10029
Advances in molecular imaging have led to the development of imaging biomarkers with tremendous potential to characterize cancer phenotype and therefore be useful as pharmacodynamic, predictive or prognostic biomarkers. These biomarkers, initially developed in pre-clinical testing ("the bench") not only face hurdles in initial clinical trials that may on occasion need further pre-clinical development. Moreover, the path from Phase 0 or Phase 1 trials to eventual pivotal studies that lead to regulatory approval requires elucidation particularly for imaging biomarkers. This overview will suggest development paradigms for imaging biomarkers, focusing on a specific biomarker and highlighting translational and relevant regulatory features.
About the Speaker(s)
Chaitanya Divgi trained in Internal Medicine and Nuclear Medicine as well as Clinical Oncology in Bombay. Dr. Divgi was at Memorial Sloan-Kettering Cancer Center, New York, from 1985 to 2006, where he developed targeted radiotherapeutics as well as molecular imaging biomarkers. He is an international authority on the utility of antigen-binding proteins in cancer, particularly as diagnostic imaging agents, and has most recently completed a Phase 3 study evaluating immunoPET in the characterization of renal masses. Dr. Divgi joined the University of Pennsylvania in May 2006 as Chief of Nuclear Medicine and Clinical Molecular Imaging, and Professor of Radiology and Radiation Oncology. Dr. Divgi revitalized the Nuclear Medicine Division, and was responsible for the growth of PET/CT at Penn. He was also responsible for the growth and development of the cyclotron/radiochemistry program, and was awarded a NCRR high-end instrumentation grant for an isotope production cyclotron. He has over 100 peer-reviewed publications. Dr. Divgi joined Columbia University as Director of PET/Nuclear Medicine and Vice-Chair, Research, Department of Radiology, in April 2011.
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