James L. Gulley

James L. Gulley is the Director, Clinical Trials Group within the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health (NIH).

Gulley graduated from Loma Linda University in California with a Ph.D. in microbiology in 1994 and an M.D. in 1995. As part of this eight-year M.D./Ph.D. Medical Scientist Training Program, designed and funded by the NIH to produce translational researchers, 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 NCI. Since 1999 he has authored and run a variety of clinical trials at the NCI, serving as Principal Investigator or an Associate Investigator on approximately 40 trials. Gulley is running several currently enrolling studies for cancer patients

Gulley is especially interested in immunotherapy for prostate cancer. As Director of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology, he takes promising laboratory findings and uses them to design and conduct clinical trials. These studies involve the use of cancer vaccine and other immunostimulatory molecules to modulate the immune response in cancer patients, and the addition of other strategies to enhance vaccine-mediated killing. He is also a Principal Investigator within the Medical Oncology Branch at the National Cancer Institute. He serves on many boards and committees including the NCI Prostate Cancer Task Force. He has authored over 125 scientific papers or book chapters, edited 3 books including the Bethesda Handbook of Clinical Oncology and has made numerous presentations at national and international meetings.

Gulley serves as the Principal Investigator of PROSPECT - a global phase III clinical trial of a cancer vaccine, PSA-TRICOM, also known as Prostvac that was initiated in November 2011. This vaccine was developed by the National Cancer Institute and licensed to Bavarian Nordic who is sponsoring this phase III study. Gulley has been involved in many of the earlier clinical trials of PROSTVAC.

Starting in 2003, Gulley, JL has authored or co-authored 82 pubmed.gov recorded papers (as of 2011), on various aspects of prostate cancer treatments including 37 co-authored with Schlom. The paper quoting Dr Schlom re:"Rethinking Cancer Vaccine Trials: Would New Measures of Success Make a Difference?"

at Sipuleucel-T (reference #14) was co-authored by Gulley, JL.

At the 2010 ASCO meeting Gulley's group reported on the use of Ipilimumab with a vector-based vaccine for advanced prostate cancer. This phase I trial using PSA-TRICOM with Ipilimumab (Ipi) showed promise for Overall Survival (OS). Ipi is used in melanoma vaccine clinical trials. It was approved by the FDA in March 2011. The understanding of cytotoxic T-lymphocyte antigen-4 (CTLA-4) which lead to the development of Ipi shows again that Gulley and his team have a considerable grasp of what can work in the human cancer vaccine arena.