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US FDA’s Khozin On Defining Big Data, Safety Signaling, And The Patient Experience in Cancer

 
• By William Looney

The challenge for users of big data "is to develop the human organizational and technical capacity to turn the 'big”' into the 'smart,' through applied analytics to personalize therapies around the distinctive disease characteristics of each patient." Khozin says.

This article accompanies a larger discussion of INFORMED and the perspectives of Sean Khozin, acting associate director of the FDA Oncology Center and founding director of INFORMED. (Also see "Big Data And The FDA: To Mine The Value, First Mind The Gaps " - In Vivo, 21 May, 2018.) FDA describes INFORMED as an "incubator for collaborative oncology regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of the public health ... Special emphasis is placed on systems thinking in oncology regulatory science research to facilitate development and adoption of new solutions for improving efficiency, reliability, and productivity in a broad range of workflows related to oncology drug development and regulatory decision making."

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