8 January 2016 Meeting Minutes

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A teleconference and webex was held on 8 January 2016. The primary agenda was to review an initial draft of the working group's poster to be presented at the FDA PhUSE Computational Science Symposium (CSS) March 13-15, 2016 in Silver Spring, MD. The group discussed possible future directions, future activities as a progression to the work conducted in 2015. Topics related to future directions included graphical displays of aggregation of historical control data and cross-domain analysis (such as exploratory biomarkers) with case examples. In addition, rules for use, guidance and limitations for graphical displays could be developed. Action items were for J Zandee of INDS to provide updated images from SEND Explorer and P Marc of Novatis to provide a different graphic from Translational Safety Platform. In addition, team members were asked to provide suggestions or topics for future activities to this working group project. The next meeting will be held 29 January 2016 to finalize the poster.