Elizabeth Duke, M.D., is a practicing pediatric neuro-oncologist who served for five years as a clinical reviewer in the FDA’s Center for Drug Evaluation and Research (CDER) Division of Oncology 2, conducting numerous reviews of INDs, NDAs, and BLAs for neuro-oncologic, pediatric solid tumor, and rare cancer products. She has provided leadership and expertise to multiple FDA projects through the Oncology Center of Excellence (OCE) in addition to national and international working groups on cancer research and drug development. Dr. Duke now guides clients through the scientific, clinical, and regulatory complexities of bringing new treatments to patients.
While at FDA, Dr. Duke contributed to a number of efforts to advance the clinical development and regulation of oncology products, serving on OCE’s real-world data and dosage optimization projects, initiatives on patient-reported outcomes, and CDER’s Artificial Intelligence Strategy and Implementation Working Group. As the FDA liaison to influential steering committees and working groups—including at the National Cancer Institute, Society for Neuro-Oncology, American Academy of Cancer Research, and National Brain Tumor Society—she helped shape the direction of drug development in the field with insights into regulatory science and innovation. She has also liaised on behalf of FDA with national and international cancer patient advocacy organizations.
Dr. Duke earned her medical degree from the University of Maryland School of Medicine and completed residencies in pediatrics and child neurology at Boston Children’s Hospital/Harvard Medical School. After completing a fellowship in pediatric neuro-oncology at Children’s National Medical Center in Washington, D.C., she became an attending physician there and currently treats patients in the Brain Tumor Clinic.