Big Data And The FDA: To Mine The Value, First Mind The Gaps
INFORMED is a new initiative at the FDA to incubate new ideas in applying big data to boost the scientific, economic and social returns from the regulation of drugs and medical devices, with a particular focus on cancer.
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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.
Some of the loudest messages from UK government's Life Science Sector Deal was the importance of using real world evidence - and the uniqueness the British health ecosystem can offer to trail blazing innovation.
Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.