Nicole Verdun | Super Office Director
Food and Drug Administration

Nicole Verdun, Super Office Director, Food and Drug Administration

Dr. Verdun (ver-done) received her undergraduate degree from Duke University and her medical degree from the University of Chicago Pritzker School of Medicine.  She then completed a Pediatrics Residency at Children’s Memorial Hospital-Northwestern University and a Pediatric Hematology-Oncology Fellowship at the Children’s Hospital of Philadelphia (CHOP).   After practicing as a hematologist with a focus on hemostasis and thrombosis, Dr. Verdun joined FDA in 2012, first in the Office of Hematology Oncology Products as a medical officer and a liaison for sickle cell therapeutics and anticoagulants, and then Therapeutic Biosimilars.  She was appointed as the Deputy Director of the Office of Blood Research and Review in the Center for Biologics Evaluation and Research (CBER) in October 2016 and was promoted to Office Director in 2018.   In 2023, Dr. Verdun was selected as the Super Office Director of the Office of Therapeutic Products, overseeing 6 Offices dedicated to the regulation and approval of Cell and Gene therapies in the United States.  She overseas both a research and regulatory portfolio in CBER. She is also on staff at Children’s National Medical Center

Appearances:



Day 2 - Thursday 24 October @ 09:45

Keynote panel: How much weight does the patient voice carry when it comes to influencing clinical trials, policy and orphan drug approvals?

- Are the current policy and regulatory frameworks in the EU helping or hindering patient access to medicines?

- How can clinicians and healthcare professionals help in developing clinical trials and regulatory pathways?

- How has the way we develop orphan drugs evolved over time (from policy, technology to engagement) with patients?

last published: 13/Oct/24 14:15 GMT

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