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

Xiangyun 'Sharon' Wang

wang.xiangyun@gene.com

Zachary Skrivanek, Eli Lilly

skrivanek_zachary@lilly

.com

Key Milestones 

ObjectiveTimelineResources

.com

Raj Kiran Boddu, Takeda

raj-kiran.boddu@takeda.com

Alex Pearce, PHUSE Project Assistant

alexandra@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2024

  • 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

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

Q1 2024


Published Deliverables

Best Practice for Interactive Analysis for Submission – CSS Poster 2020

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

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