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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 Q3/42021

Invited guests to share best practices on interactive analyses from major pharma companies. Now finalising draft white paper.

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 

Eliassen Group

Phil Bowsher

RStudio
Ramesh VenkataramanaGENINVO 

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer
Parag WaniNovo Nordisk
Pinaki BiswasPfizer

Rinki Jajoo 

Merck

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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