16 March 2018 Meeting Minutes

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A teleconference was held on 16 March 2018. P Drew gave an update on the FDA PhUSE CSS held the previous week in Silver Spring, MD. Phil gave a project update to the Nonclinical Topics Working Group, along with sharing information on the European Union's IMI initiatives - eTOX and the new eTRANSAFE initiatives. Histopathology data from eTOX were utilized to demonstrate the potential for HistoGraphic and formed the basis of proof-of-concept for the software application. The data utilized in HistoGraphic had been donated by AstraZeneca to eTOX. K Snyder gave a live demo of HistoGrpahic to the working group. Phil and Kevin presented our project team's poster and gave a live demo of HistoGraphic during the poster session, which was well received. As per Phil, if appears that the current projects within the Nonclinical Working Group will continue in 2018. Our project has reached a natural point of completion. Remaining activities for this project are to 1) verify that HistoGraphic software is readily available for open source downloading via a github and 2) request that a brief users guide be prepared and made available in the github. A Brown will communicate with K Snyder regarding these items. Otherwise, the project should be brought to closure. Final communication and teleconference will occur to bring closure. Attendees on this teleconference discussed next steps. There is significant interest to engage with the eTRANSAFE consortium in Europe to provide a means for communication and idea sharing between FDA PhUSE and eTRANSAFE. P Drew is a member of the eTRANSAFE consortium and Novartis is a consortium leader. A Brown has received internal support within Novartis for this endeavor. Topics to explore include safety signal detection, multiple domain analyses, machine learning and the role for SEND to be an enabler for these technologies. The project should be scientific and theoretical, and avoid technical aspects related to software development. Project goals will be identified and shared with the Nonclinical Topics Working Group, a new wiki page will be created and call for members to join to follow. The current project team distribution list can serve as an initial point of contact.