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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

skrivanek_zachary@lilly.com

Xiangyun 'Sharon' Wang

wang.xiangyun@gene.com

Lauren White (PHUSE Project Coordinator)

lauren@phuse.global

Objectives and 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

Q2 2021 


CURRENT STATUS Q22021

The White Paper is being restructured to reflect a new focus. Continuing discussions on a few topics related to Best Practice for Interactive Analysis.

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
Kelci MiclausIndustry
Mark  MarinoMark T Marino Consulting
Maria Dalton Industry 

Project Members 

Organisation 

Mary Nilsson 

Eli Lilly
Mominul Islam 

Sarepta Therapeutics

Nagadip Rao 

Elissen

Phil Bowsher

RStudio
Ramesh VenkataramanaGENINVO 

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer
Parag WaniNovo Nordisk

Rinki Jajoo 

Merck & Co.

Shiva Katepilli  

Sunovion Pharmaceuticals

Suhas Ravindra

GSK
Vineet Sharma Sarpeta

Vishal Shah 

Sunovion Pharmaceuticals

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion Pharmaceuticals
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