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

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

3. 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

4. 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

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

6. 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

7. 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?

8. 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

9. Demo
Genentech safety review package using Spotfire