Versions Compared

Old Version 26

changes.mady.by.user Wendy Dobson

Saved on

compared with

New Version Current

changes.mady.by.user Alex Pearce

Saved on

Key

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

Image Modified


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

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q12021New team formed and are now aligned on objectives. They are started to draft their White Paper. Due to availability of key members, progress has been slower than planned.

Q1 2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023

If you would like to join this project, email: workinggroups@phuse.global

DeliverablesTimelinesDraft document for reviewQ32021Users Guide or White PaperQ32021Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 HealthcarePreeti VenkataramanFDASwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVie