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Scope

Leverage

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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

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Email

Xiangyun 'Sharon' Wang

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wang.xiangyun@gene.com
Zachary Skrivanek

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Key Milestones 

ObjectiveTimeline
Complete the Docker POC Project Q4 2020 
Kick off the Docker pilot for a real submission Q4 2020

White Paper on best practices for interactive analyses for decision making & submissions

Q4 2020 

Status
colourBlue
titleCurrent Status

Continuing to write the White Paper, awaiting feedback from the FDA on the POC submission. 

Project Members 

Name Organisation 

Catherine Xiao

Gilead

Douglas Warfield

Ireview

Eric Herbel

Industry

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

Bayer
Maria Dalton GSK

Mary Nilsson 

Eli Lilly
Mominul Islam 

Sarepta

Nagadip Rao 

Elissen


Project Members 

Name 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


Volunteer Today

Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.