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Project

Scope

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

 Q42020New team formed and kick off meeting taken place. Presented at the recent CSSDeliverablesTimelinesDraft document for reviewQ32021Users Guide or White PaperQ32021

Q1 2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023
Project MembersCompanyAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 HealthcarePreeti VenkataramanFDASwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVie