Crowd-Sourcing an Interactive Safety Review Package Analysis and Display White Papers project team and Data Visualizations for Submissions project team 06 November 2018

Agenda Summary of projects related to interactive safety review Demo of a Spotfire package from Genentech

Overview: Script Repository Vision: Collaboration platform and Shared Reusable Code Library FDA Industry Academia Script Repository in Github Spotfire Safety Review Package – SDTM and ADaM Script Metadata Test Data White Paper Scripts SAS, R, Spotfire, Etc. Working Group: Standard Analyses and Code Sharing Project Team: Code Sharing Contributed Scripts Code Test Environment

Background: Open Tool Box Vision: From Everyone Building Their Own Tools to Shared Tools Shared Value Text Vision to shared tools Shared tools Working Group: Standard Analyses and Code Sharing Project Team: Code Sharing

Describe desired content for interactive safety review Working Group: Standard Analyses and Code Sharing Project Team: Analysis and Display White Papers

Code Sharing – Wish List for FDA Continue to share code Some code shared, but we understand there is more that may make sense to share Use code from the repository FDA representatives stay aware of what has been contributed or developed and leverage where possible Help identifying areas where crowd-sourcing the creation of a shared tool makes sense Interactive safety review? Reduce some common errors in e-submission? Sept 2018 PhUSE FDA Forum Meeting Working Group: Standard Analyses and Code Sharing Project Team: Code Sharing

Data Visualizations Data visualizations for submissions How to share an interactive display and/or interactive tool Multiple potential approaches Share custom display/tool – company versus 3rd party versus regulatory server versus alternatives Share general tool to read from any company’s SDTM or ADaM – crowd-source the creation starting with all the shared learning? If so, align on software?

Other Groups DIA/ASA Biopharm Safety Graphics WG FDA Working on interactive tools, starting with liver, using R Shiny? FDA Piloting R Shiny for something safety related? Individual companies Likely more

Demo Genentech safety review package using Spotfire