3 June 2016 Meeting Minutes

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A teleconference and webex was held on 3 June 2016. The primary agenda item was to review the initial sections drafted for the manuscript describing the poster presented at the 2016 FDA PhUSE CSS. K Wuersch was introduced to the group and will prepare the methods section for the survey conducted at the 2015 European Society for Toxicologic Pathology, along with reformatting of tables/graphs of those survey results. The internal survey conducted amongst the working group was qualitative in nature whereas the survey conducted at the pathology meeting utilized Turning Point software and provided quantitative data. FDA is interested in conducting a similar internal survey, and FDA members of this working group will be provided with the 2016 poster for guidance with respect to surveying fellow Pharm/Tox Reviewers. It was agreed that the manuscript should stay focused on the 2015 activities and poster. The manuscript discussion could provide ideas and discussion regarding future topics and applying the concepts and technology for displaying histopathology data to other study domains, such as clinical signs. In-life clinical signs data are qualitative with incidence counts, but differ due to multiple time-course entries. The discussion should also address differences in survey demographics/participants between the internal survey and the one conducted at the pathology meeting. The results section should mention the example graphics to be provided as figures, along with mentioning the software demonstrations viewed as a group. The results section should indicate the software tools available for graphical display. An advantage of the technology that should be highlighted is the ability to select tissues and/or lesions of interest and to deselect data that is not of interest. The next working group meeting will be 24 June 2016. Individual authors should revise their sections accordingly and comments/edits provided to P Drew for compilation.