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Naomi Lowy
Naomi Lowy

Naomi is senior vice president of global regulatory affairs at Latigo Biotherapeutics. Naomi brings extensive regulatory and drug-development expertise, including an 18-year career at the U.S. Food and Drug Administration (FDA), in the Office of New Drugs in the Center for Drug Evaluation and Research. She served as Associate Director for Regulatory Science in the Office of Drug Evaluation I, Deputy Director of the Division of General Endocrinology as well as Deputy Director of the Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP). In DAAP, she oversaw the regulation of drugs to treat pain of all etiologies, including novel non-opioid analgesics, and was signatory authority for analgesic New Drug Applications. In her role, she led DAAP in Advisory Committee meetings and public workshops related to analgesic drug development and co-authored FDA Guidances on Development of Non-Opioid Analgesics for Acute and Chronic Pain.

After departing the FDA in 2025, she joined Hyman, Phelps & McNamara, P.C. in Washington, DC, where she advised biopharmaceutical companies on complex development strategies and helped navigate pre-approval regulatory challenges.

Naomi has a B.S. in Biology from the University of California, Los Angeles and an M.D. from New York Medical College. After completing her Internal Medicine residency at Montefiore/Einstein, she completed a fellowship in Endocrinology, Diabetes and Metabolism from New York University School of Medicine.

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