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INFORMED: Information Exchange and Data Transformation

Launched in collaboration with the U.S. Department of Health and Human Services’ Innovation, Design, Entrepreneurship and Action (IDEA) Lab, Information Exchange and Data Transformation (INFORMED) is an incubator for collaborative regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of public health. Drawing from the expertise of a diverse group of physicians, 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. Special emphasis is placed on systems thinking in regulatory science research to facilitate the development and adoption of new solutions for improving efficiency, reliability, and productivity in a broad range of workflows related to drug development and regulatory decision making.

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 open-access platforms and emerging technologies such as blockchain to enable secure exchange of health data at scale. In addition, INFORMED is actively pursuing the development of programs to support creation of a knowledgeable, sustainable, and agile data science workforce capable of addressing the needs of cancer patients in today’s technology-driven and connected world.

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