Page tree
Skip to end of metadata
Go to start of metadata


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

Paula Rowley (PHUSE Project Assistant)

paula@phuse.global 

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

Q3 2022


CURRENT STATUS Q2/3 2022

Invited guests to share best practices on interactive analyses from major pharma companies. Project are finalising white paper summarising UI patterns for submissions.

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 
Ari Siggaard KnophNovo Nordisk
Bhavin SolankiBayer
Darshan BhattIndustry 

Catherine Xiao

Gilead

Douglas Warfield

FDA

Eric Herbel

Integrated Clinical Systems

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

Bayer
Kapil AnandParexel International
Kelci MiclausIndustry
Lixiao ChenBristol Myers Squibb
Mark  MarinoMark T Marino Consulting
Maria Dalton Industry 

Project Members 

Organisation 

Mary Nilsson 

Eli Lilly
Mominul Islam 

Sarepta Therapeutics

Nagadip Rao 

Eliassen Group

Parag WaniNovo Nordisk

Phil Bowsher

RStudio
Pinaki BiswasPfizer
Ramesh VenkataramanaGENINVO 

Raj Kiran Boddu 

Takeda

Rinki Jajoo 

Merck

Shiva Katepilli  

Sunovion Pharmaceuticals

Suhas Ravindra

GSK
Sumeet UppalRegeneron Pharmaceuticals
Vineet MathurBristol Myers Squibb
Vineet Sharma Sarpeta

Vishal Shah 

Sunovion Pharmaceuticals

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion Pharmaceuticals
  • No labels