12 April 2017 Meeting Minutes

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A teleconference/webex was held on 12 April 2017. A Brown gave an update and review of the agenda from the March 2017 FDA-PhUSE CSS held in Silver Spring, MD. Support for continuation of the project team was enthusiastically endorsed. The project team has received authorization to access and utilize toxicology study data from the IMI eTOX consortium for project goals. An initial goal will be incorporation of multi-study histopathology data into the "sunburst" or "HistoGraphic" application being developed by K Snyder. Another project will be simultaneous display of clinical laboratory data with histopathology data in this application. K Snyder has already made significant progress on this and provided a live demo of this application during the webex. The project team will inquire with eTOX as to studies that are either SEND compatible and/or have liver toxicity findings so as to graph liver lesions versus serum chemistry changes (ex, ALT, AST, bilirubin). Non-SEND data can be reconfigured by working group members. It will be important to identify studies with noteworthy pathology findings so as to explore the use of color codes as visual cues for lesion severity. Numeric clinical lab data should be converted to fold-control, fold-normal or Z-scores so as to provide a means for color scoring the magnitude of change observed. Studies with noteworthy clinical lab changes should be identified so as to explore the dynamic range of color scoring. The IMI eTOX database has approximately 7000 studies, so curation will be important. Categorizing magnitude of change for serum chemistry or biomarker data can be attempted by creating buckets of change, or by writing a rule for fold or magnitude of change. Development of Histographic application by K Snyder key aspect of collaboration across Nonclinical Topics project teams.