Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Image Removed

Image Added


Project Scope

Leverage Visual Analytics in our submission package to improve interactions between regulatory agencies and sponsors for a fast and effective review of submitted data and analyses.



Project Leads

Email

Zachary Skrivanek, Eli Lilly

skrivanek_zachary@lilly.com

Xiangyun 'Sharon' Wang, Genentech

wang.xiangyun@gene.com

Zachary Skrivanek

skrivanek_zachary@lilly.com

Key Milestones 

ObjectiveTimeline

Raj Kiran Boddu, Takeda

raj-kiran.boddu@takeda.com

Kerry Robson, PHUSE Project Assistant

kerry@phuse.global


Status
colourBlue
titleCurrent Status
Q1 2024

  • Publishing WP
  • Planning for the next stage of the project







Objectives & DeliverablesTimelines
Complete the Docker POC Project On hold
Kick off the Docker pilot for a real submission On hold

White Paper on best practices for interactive analyses for decision making & submissions

Q4 2020 

Status
colourBlue
titleCurrent Status
 Q42020

Continuing to write the White Paper, docker/Shiny portion of the project on hold, looking for new FDA representative. 

Resources

Project Members 

Organisation 

Phil Bowsher

Rstudio

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Rinki Jajoo 

Merck

Shiva Katepilli  

Sunovion Pharmaceuticals

Vishal Shah 

Sunvion

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion
Q1 2024


Published Deliverables

Best Practice for Interactive Analysis for Submission – CSS Poster 2020

DevOps in Action, Containers@Bayer- Presentation by Karl Brand 21-03-19

Project Members 

Organisation 

Catherine Xiao

Gilead

Douglas Warfield

Ireview

Eric Herbel

Industry

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

BayerMaria Dalton GSK

Mary Nilsson 

Eli LillyMominul Islam 

Sarepta

Nagadip Rao 

Elissen