James L. Gulley, M.D., Ph.D.

James L. Gulley, M.D., Ph.D.
Chief
Senior Investigator
Head, Immunotherapy Section
Director, Medical Oncology Service, CCR Office of the Clinical Director

Dr. Gulley is an internationally recognized expert in cancer immunotherapy with a strong interest in prostate cancer. Since 1998 he has authored and run a variety of clinical trials at the NCI. These innovative, investigator-initiated studies involve the use of cancer immunotherapy to (a) initiate immune responses, (b) expand immune responses and/or (c) allow the immune responses to be effective within the tumor microenvironment.

In addition to his role as Branch Chief, Dr. James L. Gulley is also Director of the Medical Oncology Service, Office of the Clinical Director.

Areas of Expertise

1) immunotherapy, 2) therapeutic cancer vaccines, 3) immune checkpoint inhibitors,
4) prostate cancer, 5) clinical trials, 6) combining immunotherapy with other therapies

Contact Info

James L. Gulley, M.D., Ph.D.
Center for Cancer Research
National Cancer Institute
Building 10, Room 13N240
Bethesda, MD 20892-1750
Ph: 301-480-7164
Fax: 301-480-8867
gulleyj@mail.nih.gov

Dr. Gulley is especially interested in immunotherapy for prostate cancer. He works collaboratively with the Laboratory of Tumor Immunology and Biology, CCR and others, and takes promising laboratory findings and uses these to design and conduct clinical trials. These innovative, investigator-initiated studies involve the use of cancer vaccines and other immunostimulatory agents to modulate the immune response in cancer patients, and the addition of other strategies to enhance immune-mediated killing. He has been instrumental in the clinical development from first-in-human studies through large efficacy seeking studies for multiple immunotherapy agents including Prostvac, avelumab and bintrafusp alfa, a first in class bifunctional antibody targeting PDL1 and TGF-beta.

NIH Scientific Focus Areas:
Clinical Research, Immunology
  1. Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL.
    Clin Cancer Res. 24(6): 1287-1295, 2018. [ Journal Article ]
  2. Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL.
    J Clin Oncol. 35(19): 2117-2124, 2017. [ Journal Article ]
  3. Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL.
    Lancet Oncol. 13: 501-8, 2012. [ Journal Article ]
  4. Abdul Sater H, Marté JL, Donahue RN, Walter B, Heery CR, Steinberg SM, Cordes LM, Chun G, Karzai F, Bilusic M, Harmon S, Turkbey IB, Choyke P, Schlom J, Dahut WL, Madan RA, Pinto PA, Gulley JL*
    J ImmunoTher Cancer. 8: BMJ e000655, 2020. [ Journal Article ]
  5. Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Galceran JC, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW
    J Clin Oncol. 37: ASCO 1051-1061, 2019. [ Journal Article ]

Dr. James Gulley is an internationally recognized expert in immunotherapy for cancer. He 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). 

 

Dr. Gulley serves within the Center for Cancer Research (CCR) of the National Cancer Institute as Chief of the Genitourinary Malignancies Branch (GMB), the Director of the Medical Oncology Service (CCR), and also Head of the Immunotherapy Section within the GMB. He has been instrumental in the clinical development 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 serves as the coordinating PI of the international bintrafusp alfa, a bifunctional agent targeting PDL1 and TGF-beta. He also leads a number of rationally designed, cutting edge combination immunotherapy studies.

 

Dr. Gulley serves on many national and NIH boards and committees as well as the board of LLUH. He has been an investigator on more than 170 clinical trials, authored 325 scientific papers or chapters which have been cited over 7,500 times, serves on a number of editorial boards and 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 8 NCI or NIH Director’s Awards.

Name Position
Houssein Abdul Sater, M.D. Assistant Research Physician
Marijo Bilusic, M.D., Ph.D. Associate Research Physician
Isaac Brownell M.D., Ph.D. Adjunct Investigator
William Figg Predoctoral Fellow (Graduate Student)
Amy Hankin PA-C, MMSc Physician Assistant
Christopher Heery M.D. Special Volunteer
Kazusa Ishii M.D. Assistant Research Physician
Fatima Karzai, M.D. Assistant Research Physician
Michell Manu R.N. Research Nurse (Contr.)
Jennifer Marte M.D. Clinical Research Coordinator
Lee Pai-Scherf M.D. Clinical Collaborator
Jason M. Redman, M.D. Assistant Research Physician
Marc Theoret M.D. Clinical Collaborator
Armine Tumasyan M.D., M.P.H., CCRP Clinical Research Associate II (Contr.)
Monique Williams N.P. Nurse Practitioner (Contr.)