6 January 2017 Meeting Minutes

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A teleconference/webex was held on 6 January 2017. A draft of an abstract for the upcoming FDA PhUSE CSS (19-21 March 2017 in Silver Spring, MD) was reviewed. There was general consensus regarding the abstract which was previously distributed for review amongst the project team members. Authors will be those individuals providing images or content for the poster and/or presenting the poster at the meeting. A request was made for screen shots/images of graphical display of histopath data was made, to highlight the concept for displaying data from multiple studies or sources. A Brown then shared various screen shots from the Novartis TSP application in which data from 2 or more studies was selected and graphed simultaneously in a bar graph display. TSP utilizes Spotfire software and is custom developed for Novartis. It incorporates SEND-compatible data. K Snyder of FDA gave a demonstration of the Krona software starburst plots in which he has made application-software changes to make the application more custom. This activity is also a component of the Scripts Nonclinical Working Group. Anonymous data from 2 different sources (tox studies) was loaded and displayed. Data from each study are not displayed simultaneously but are selected. The plots display data in a hierarchy such as tissue, finding, dose, sex and then animal. Individual animals can be selected to display all findings for that subject. Severity scores are represented by a color scale. Data from multiple studies can be displayed by creating separate windows for each plot, side by side on the screen. R Ramesh of PointCross provided a demonstration of their starburst plots which can provide data from 2 different studies in plots side-by-side on the display screen. A more recent design for histopath data was shared which presents data in bar charts which are linked to pie-charts (Dimensional Data Explorer). This design can present data from multiple studies side-by-side. A question was asked whether a master visualization can be created for control pathology data ? There was also interest with including a heat map visualization for the poster.