3 March 2017 Meeting Minutes

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A teleconference and webex was held on 3 March 2017. A Brown presented the final version of the working group's poster to be presented at the upcoming FDA PhUSE CSS on 20 March 2017. The group reviewed a 2-slide update on the past year's activities for the working group with proposed objectives for 2017. This update will be presented at the FDA PhUSE CSS to the Nonclinical Topics Working Group during a breakout session. A Brown will lead a discussion at the CSS on data visualization and K Snyder will provide updates on script development and display software, including sunburst plots. Note: the sunburst plot software was originally developed with funding from the US Dept of Homeland Security and the Krona name is trademarked. As the software is freeware and redesigned for our use, we cannot use the Krona name and will refer to the software as Sunburst plots. The group proposes to generate a mock data set of SEND-compliant histopath data from multiple studies for incorporation into various software applications for graphical display and comparison. A proposal was made to first prepare a list of questions for interrogating the data sets which will provide guidance to the software users for analyzing and displaying the data. Examples include: 1) Are lesions in organ X produced by different drugs in different studies ? 2) What lesions of high severity, low incidence are present in different data ? This is an intriguing question because standard data tables are difficult to interrogate for low incidence lesions. 3) Is it possible to use visual cues such as color codes to rapidly scan large data sets for outlier lesions or trends across studies ? These analyses can form the basis for preparing a manuscript as a output from the current poster. The group also endorsed further evaluation of IMI's eTOX pathology data and obtaining better curated data for incorporation into the Sunburst display software. A Brown and P Drew will follow up with P Marc regarding the eTOX data. The eTOX data are not SEND compatible but we should inquire as to more recent data which have usable incidence and severity scores. K Snyder has placed the sunburst display software on the github that PhUSE is managing for the clinical data group. S Madhaven indicated that the working group's posters and or paper will be shared at a Japanese Toxicology Meeting with more details to follow.