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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 Pharma)

terry.walsh@astellas.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global 


Objectives & Deliverables

Timelines 

Draft of the initial scope (Stage 1) White Paper 

Q22022Q3 2022


  • The group have started to draft their White Paper and is currently in progress.
    • Wide scope of examples have now been gathered.

    Status
    colourBlue
    titleCurrent Status
    Q12022

    Q3 2022

    • Drafted the initial scope (stage 1) 



    Project MembersOrganisation
    Amelia PangSanofi
    Charles BeasleyMSN
    Darshan Bhatt Industry 
    Eileen Navarro AlmarioFDA
    Hongli LuMerck
    John Landry Eli Lilly
    John MarciankAbbVie
    Patrick HannonMMS 
    Paul HayashiA2 Healthcare Corporation
    Preeti VenkataramanFDA
    ShayamiEli Lilly
    Swarnalatha ReddyIndustry
    Veronical Pei YangFDA
    William Palo AbbVie