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Sean Khozin is a board-certified oncologist and physician-scientist combining translational and clinical research with data science and health technology to address today’s challenges in therapeutic development. Dr. Khozin currently serves as Associate Director at FDA’s Oncology Center of Excellence, managing key aspects of the approval and regulation of oncology drugs, biologics, devices, and diagnostics. Areas of focus include novel clinical trial designs, big data analytics, real world evidence, complex phenotyping, and digital biomarker development. Dr. Khozin is also the founding Director of Information Exchange and Data Transformation (INFORMED; www.fda.gov/INFORMED), FDA’s first data science and technology incubator focused on de-risking emerging science and technology solutions by structuring strategic partnerships and supporting collaborative translational and clinical research studies to advance therapeutic development goals consistent with the agency’s public health priorities. Previously, Dr. Khozin was founder and Chief Medical Officer of SKMD, a multidisciplinary healthcare delivery network, and cofounder of HelloHealth, a health technology company specializing in building interoperable systems with telemedicine, point-of-care data visualization, and advanced analytics capabilities to optimize patient care and clinical research.