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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

Raj Kiran Boddu, Takeda

raj-kiran.boddu@takeda.com

Lauren White (

Kerry Robson, PHUSE Project

Coordinator)

Assistant

lauren@phuse

Key Milestones 

ObjectiveTimeline


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
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

Interactive Data Visualisations for Decision Making in Submissions – PHUSE Webinar Wednesday 2019

Project Members 

Organisation 

Catherine Xiao

Gilead

Douglas Warfield

FDA

Eric Herbel

Integrated Clinical Systems

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

BayerMaria Dalton GSK

Mary Nilsson 

Eli LillyMominul Islam 

Sarepta

Nagadip Rao 

Elissen

Project Members 

Organisation 

Phil Bowsher

Rstudio

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Rinki Jajoo 

Merck

Shiva Katepilli  

Sunovion 

Vishal Shah 

Sunovion

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion