A Regulatory Leader in Rheumatology

Dr. Siegel

I’ve always been fascinated by the science of immunology, and I wanted to make basic science a part of my career,” reflects Jeffrey N. Siegel, MD, from his office at the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) in Rockville, Md. “I thought that rheumatology was an area where the new findings from the field of immunology could be translated into clinical therapies for patients. It’s amazing how true that has turned out to be.”

By his conscious choice to work within the government’s regulatory framework, Dr. Siegel has found a way to bring clinical therapies to patients and to serve the FDA’s dual mission to protect and advance the public health. As clinical team leader and supervisory medical office at CDER’s Office of New Drugs, Office of Drug Evaluation II, and Division of Anesthesia, Analgesia, and Rheumatology Products, Dr. Siegel has fostered successful collaborations among clinicians, pharmaceutical companies, and patient advocates to advance the novel treatments now available for rheumatic diseases.

“One of his greatest strengths is that he lent a collaborative atmosphere to working with the drug companies to achieve common goals,” says Daniel E. Furst, MD, the Carl M. Pearson Professor of Rheumatology, Department of Medicine, Division of Rheumatology, at the David Geffen School of Medicine at the University of California, Los Angeles. “Jeff changed the way the FDA is perceived, from a purely adversarial one to a guiding one.”

Conscious Career Choices

Following an internal medicine residency at Case Western Reserve University Hospitals in Cleveland, Dr. Siegel served as a rheumatology fellow there. It was there that Dr. Siegel observed patients’ positive responses to methotrexate therapy, then a new treatment for rheumatoid arthritis (RA). After Case Western, Dr. Siegel moved to the National Institutes of Health in Bethesda, Md., for fellowship training in immunology and molecular biology. He was inspired by lab chief Richard Klausner, MD, and Carl June, MD, head of the immunology group at the Naval Medical Research Institute in Bethesda, Md.

Based on some of the basic science immunology he had been working on—and inspired by Dr. June’s ability to translate basic science ideas into clinical research—Dr. Siegel knew that treatments for rheumatology were in development. He applied to the FDA, and it turned out to be “a perfect time” to join the administration, because cytokine-blocking therapies were just beginning to be studied in RA and other rheumatic diseases. Given early clinical results with Enbrel (etanercept) as one of his first projects as a junior reviewer, Dr. Siegel realized that his hope—that the immunology idea could be translated into clinical therapies—was probably correct. “But I needed to make a decision; I could keep one foot in the basic science laboratory world, or change my direction entirely.”