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Markham Luke, M.D., Ph.D.

Position
Director
Company
U.S. Food and Drug Administration
Bio

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Since 2016, Markham serves as the Director of the Division of Therapeutic Performance in the Office of Research and Standards at FDA's Office of Generic Drugs. The Division of Therapeutic Performance is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products. Markham is a strong advocate for medical product development for rare diseases and special populations. He has interfaced with training staff on developing reviewer development initiatives in CDRH while serving as Deputy Office Director and Chief Medical Officer (2008-2016) and CDER as the Lead Medical Officer for Dermatology (1998-2008), and has been a preceptor and mentor for the FDA Commissioner's Fellows Program since 2009. In addition, Markham serves in the role of consultant dermatologist to various parts of FDA. Markham's education background includes fellowship and residency at the National Cancer Institute, Bethesda and Washington University, St. Louis. Medical school and Ph.D. in Pharmacology at Johns Hopkins University. Biochemistry with concentrations in Math and Music at New York University.
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