Dr. Robert Leone is an oncologist in the Division of Oncology 3. He joined the FDA as a medical reviewer in January 2024.

What is your educational and professional background?

Originally from New York City, I went to Yale for medical school, followed by internship and residency in Internal Medicine at The University of Pennsylvania. I completed fellowship training in Medical Oncology at Johns Hopkins Hospital.

Throughout my training I have had a keen interest in the how the immune system responds to cancer. In this regard, I was fortunate to have been exposed to some of the most exciting advances in this field throughout my training: as a rotating medical student in Dr. Mario Sznol’s clinic at Yale where I saw some of the very first melanoma patients experiencing miraculous responses to the first checkpoint inhibitor, ipilimumab; as a member of the house staff at The University of Pennsylvania where I saw some of the first patients benefitting from the revolutionary new cellular therapy known as CAR-T cell therapy; and as a fellow at Johns Hopkins where many of the groundbreaking studies using the novel checkpoint inhibitor anti-PD-1 were being pursued. 

After my oncology fellowship, I joined the faculty as an Assistant Professor at the Bloomberg-Kimmel Institute for Immunotherapy at Johns Hopkins. As a principal investigator of a basic laboratory at Hopkins, I have focused on investigating the relevance of the metabolic characteristics of cancerous tumors to immune cell function. Through this work we have uncovered several fundamental mechanisms by which the metabolism of cancer can markedly suppresses the anti-tumor immune response. We demonstrated that metabolic pathways such as adenosine generation and glutamine catabolism could be targeted to improve immune response and dramatically enhance the effect of immunotherapies such as anti-PD1 and CAR-T cell therapy. These basic science findings have provided the preclinical basis for several clinical trials, and I like to think helped establish the idea that cancer metabolism is, in and of itself, an immune checkpoint.

What motivated you to join FDA Oncology?

I pursued a career at the FDA because I was looking for a way of uniting my interests in basic science and clinical work all under one roof, so to speak. I saw the FDA as a way of working in the world of drug development from a unique vantage point, one where I could use both my basic science skills and clinical training to help guide and participate in the entire process. I was also attracted to what I understood to be a much different culture at the FDA compared to academia or industry, wherein the work is perhaps a bit less about self-interest, is highly collaborative, and more palpably towards the serving of a common goal. Two of my former co-fellows at Hopkins, Kelly Norsworthy and May Saung, who are here at the FDA were critical to my understanding of the FDA and my desire to join the agency.

What do you like to do in your free time?

I have a frisky dog and twin 15-year-old boys who keep my wife and I very busy with fun things. We love going to baseball games, art museums, discovering great pizza, and hiking. Music has also always been a big part of my life. I studied composition and played jazz trombone for several years before medical school, and I recently started playing again. I love traveling and experiencing different cultures. Some of my favorite places include India, Morocco, and Death Valley National Park (I love the desert!).

Contact FutureofHemeOnc@fda.hhs.gov if interested in job opportunities or to learn about benefits such as loan repayment and Quality of Worklife at FDA.