Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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


Status
colourBlue
titleCurrent Status
Q1 2024

  • Publishing WP
  • Planning for the next stage of the project







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 

Status
colourBlue
titleCurrent 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.

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 Ari Siggaard KnophNovo NordiskBhavin SolankiBayerDarshan BhattIndustry 

Catherine Xiao

Gilead

Douglas Warfield

FDA

Eric Herbel

Integrated Clinical Systems

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

BayerKelci MiclausIndustryMark  MarinoMark T Marino ConsultingMaria Dalton Industry 

Project Members 

Organisation 

Mary Nilsson 

Eli LillyMominul Islam 

Sarepta Therapeutics

Nagadip Rao 

Eliassen Group

Phil Bowsher

RStudioRamesh VenkataramanaGENINVO 

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

BayerParag WaniNovo Nordisk

Rinki Jajoo 

Merck

Shiva Katepilli  

Sunovion Pharmaceuticals

Suhas Ravindra

GSKVineet Sharma Sarpeta

Vishal Shah 

Sunovion Pharmaceuticals

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion Pharmaceuticals