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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

Pharma)

terry.walsh@astellas.com

Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

nicky@phuse.global

 

Objectives & Deliverables

Timelines 

White Paper 

Q3 2022


Status
colourBlue
titleCurrent Status

Q3/4 2022Work towards releasing stage 1 of the draft white paperfor public review

Q1 2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023
 Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn Landry Eli LillyJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDAShayamiEli LillySwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVie