James L. Gulley M.D., Ph.D., F.A.C.P.
Dr. James Gulley is an internationally recognized expert in immunotherapy for cancer.
Dr. Gulley serves within the Center for Cancer Research of the National Cancer Institute (NCI) as co-Director of the newly formed Center for Immuno-Oncology, the Director of the Medical Oncology Service, and Deputy Director of the CCR. He has been instrumental in the clinical development multiple immunotherapeutic agents and has led numerous first-in-human immunotherapy studies through phase 3 clinical trials during his 24-year tenure at the NCI. 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 and has good clinical activity in HPV associated malignancies. He also leads a number of rationally designed, cutting edge combination immunotherapy studies.
Dr. Gulley was a founding editor of the Clinical / Translational Section of JITC and currently serves as the Deputy Editor in Chief. He also serves as the NCI Liaison to SITC and has chaired or co-chaired 4 SITC committees or taskforces. He also serves on numerous 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.
SITC Election Platform Statement
What are the two or three critical issues facing the field of cancer immunotherapy?
There are several critical issues facing the field of cancer immunotherapy. I would like to frame these in terms of the impact on patients. Current immunotherapy approaches induce rapid, deep, and most importantly durable responses to immunotherapy across a wide range of different tumors including patients who may have functional cures. However, a substantial proportion of patients have no response or a transient response.
- The most pressing need for the field is to expand the number of patients who have deep and durable responses or functional cures. To do this we need to deeply interrogate and therapeutically address the mechanisms of immune escape and resistance through sophisticated, high dimensional analysis of pre-treatment vs. post treatment tumor tissue and liquid biopsy along with clinical annotation. The neoadjuvant setting offers many opportunities for addressing the impact of immunotherapy on the tumor microenvironment. This in-depth analysis will inform rational combination approaches that target key components of the immune system and tumor phenotype.
- Synthetic biology has opened up new therapeutic avenues that hold significant promise. We should capitalize on this area of research to bring effective cell therapy approaches into solid tumors. This also has implications for immunocytokines, conditional binding antibodies, and other novel biologics.
- An area of research that has important implications for patients is immune related adverse events (irAE). A deeper understanding of the mechanisms involved may lead to improved therapeutic options, monitoring and prediction for irAE, and lead to safer combination therapy approaches and more patient friendly treatments for irAE.
What is your vision for SITC?
My vision for SITC can be framed by impact on patients, impact on science, and strategic growth.
Impact on patients
A relatively recent analysis suggested that we could decrease cancer deaths by 22% through wider adoption of known prevention approaches and interventions coupled with broader access to care (R. Siegel et al., CA Cancer J Clin 2018). This highlights the importance of equity. SITC is well positioned to address this both directly through education and indirectly through advocacy. Health literacy, especially as it relates to immunotherapy, is the bedrock on which to build health equity. SITC is already a leader in education for oncologists and primary healthcare providers. Existing clinical practice guidelines could be utilized to make plain language summaries. SITC could also advocate for decreasing burdens on patients enrolling on clinical trials. The adoption of digital health approaches (wearables and telehealth) could not only provide better access to care, but help understand functional status of patients over time, leading to new patient centric regulatory endpoints. These efforts would build trust and understanding in patients. In addition, a scientific program to study immune related adverse events would highlight the patient focus.
Impact on Science
The areas of critical need in the field outlined above can be greatly accelerated by SITC. SITC is the largest professional organization dedicated to immunotherapy of cancer and can (and does) assemble a critical mass of engaged stakeholders to address these key areas in a variety of meeting types. While the flagship annual meeting serves as an anchor, and virtual workshops over the past few years have been important, new Keystone-style meetings could bring in eager young investigators along with seasoned scientists and translationally minded clinicians to study a specific aspect of immunotherapy in depth. These smaller meetings allow for a free exchange of ideas and foster collaboration so critical to the field.
One way to grow membership is to expand partnerships with relevant stakeholders in related or relevant fields. There are a number of opportunities to increase collaborations with other oncology focused organizations (e.g., AACR, ASCO, SU2C, ESMO, CRUK, Clinical Oncology Society of Australia/Medical Oncology Group of Australia, ASGCT, ISCT, PICI, SBE, NCI’s Center for Global Health). There are also opportunities to partner with engineers and mathematicians for synthetic biology, TCR discovery or AI/machine learning. Growth of SITC in Europe, Asia and Australia will bring a wealth of ideas and talented individuals to help accelerate knowledge. In addition, SITC should continue to advocate for Federal funding of curative immunotherapy approaches, expanding its reach. Finally, SITC should work with partners in media and Hollywood (e.g., SU2C) for opportunities to highlight the power of immunotherapy as well as promote educational opportunities.