Sean Khozin, M.D., M.P.H.

Sean Khozin, M.D., M.P.H.

Acting Associate Director, Oncology Center of Excellence; Founding Director, Information Exchange and Data Transformation, U.S. Food and Drug Administration

Dr. Khozin is acting associate director at of the Oncology Center of Excellence and founding director of Information Exchange and Data Transformation (INFORMED), an incubator for collaborative regulatory science research focused on supporting innovations that enhance the mission of the U. S. Food and Drug Administration (FDA) mission of promotion and protection of the public health. Drawing from the expertise of a diverse group of subject matter experts, data scientists, statisticians and entrepreneurs-in-residence, INFORMED is expanding organizational and technical infrastructure for big data analytics and examining modern approaches in evidence generation to support regulatory decisions.

The research portfolio of INFORMED includes investigations into the use of real world data for clinical evidence generation and prospective pragmatic clinical trials, testing the utility of biosensors and the internet of things to quantify intrinsic and extrinsic (e.g., environmental) factors influencing the patient’s experience, identifying opportunities for machine learning and artificial intelligence to improve existing practices, and exploring the utility of emerging technologies such as blockchain to enable secure exchange of health data at scale.

Previously, Dr. Khozin was in private practice in New York City, an attending physician at St. Vincent’s Hospital in Manhattan and an entrepreneur specializing in building health information technology systems with virtual patient management (including video, structured email, short message service and remote biometric monitoring) and point-of-care data visualization and analytics capabilities.

Dr. Khozin’s professional recognitions include the 2017 Charles A. Sanders Life Sciences Award (accepted on behalf of the FDA), the 2017 FDA Commissioner’s Group Award for the Naloxone App Challenge, and the 2004 Abraham Lilienfeld Award in Biostatistics and Advanced Analytics.