James Gulley, MD, PhD, FACP, is an internationally recognized expert in immunotherapy for cancer. He serves within the Center for Cancer Research (CCR) of the National Cancer Institute (NCI) as Co-Director of the Center for Immuno-Oncology, the Deputy Director of the CCR and the Acting Clinical Director, NCI. He has been instrumental in the clinical development of multiple immunotherapeutic agents and has led multiple first-in-human immunotherapy studies through phase 3 clinical trials. He was the coordinating PI of an international trial of avelumab that led to regulatory approval. He was the PI of the first-in-human international study of a first in class agent, bintrafusp alfa, which targets PDL1 and TGF-beta. He also leads a number of rationally designed, cutting edge combination immunotherapy studies.
James is a founding editor of the Clinical / Translational Section of Journal for ImmunoTherapy of Cancer (JITC). He serves on many national and NIH boards and committees. He has been an investigator on over 200 clinical trials and has authored over 350 scientific papers or chapters which have been cited over 20,000 times. He has made hundreds of scientific presentations at universities or national / international meetings. He has had multiple awards including the 2010 Presidential Early Career Award for Scientists and Engineers, the highest award bestowed by the US President on investigators early in their careers. He also was awarded the 2018 Hubert H. Humphrey Award for Service to America for contributing to the health, safety, and well-being of the nation by helping to get FDA approval for avelumab for Merkel cell carcinoma and urothelial carcinoma and has received 10 NCI or NIH Director’s Awards.
James graduated from Loma Linda University in California with a PhD in microbiology in 1994 and an MD in 1995. As part of this eight-year MD/PhD Medical Scientist Training Program, he completed a dissertation on tumor immunology. He completed his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship at the National Cancer Institute (NCI).