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Scope

Project

Scope 

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.



Project LeadsEmail

Melvin Munsaka

  

, AbbVie

melvin.munsaka@abbvie.com

Terry Walsh, Astellas

terry.walsh@astellas.com

Paula Rowley (

Nicola Newton, PHUSE Project Assistant

)

paula@phuse

nicky@phuse.global

 


Status
colourBlue
titleCurrent Status

 Q22021

New team formed and are now aligned on objectives. They are started to draft their White Paper and is currently in progress. Due to availability of key members, progress has been slower than planned.
If you would like to join this project, email: workinggroups@phuse.global

Q1 2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

TimelinesDraft document for reviewQ32021Users Guide or White PaperQ32021Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDASwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVieShayamiEli Lilly
Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023