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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)

terry

terrencewalsh@yahoo.

walsh@astellas.

com

Katie Warren (

Nicola Newton, PHUSE Project

Assistant)

Coordinator

katie@phuse

nicky@phuse.global

 

Objectives & Deliverables

Timelines 

Finalise stage 1 of draft White Paper for Public Review

Q2 2023William Palo AbbVie


Status
colourBlue
titleCurrent Status

Q1 2023
  • Working on a White Paper
Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn Landry Eli LillyJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDAShayamiEli LillySwarnalatha ReddyIndustryVeronical Pei YangFDA

(Updated Quarterly) 

  • Stage 2 white paper draft moving along well​
  • Stage 1 white paper Hepatotox R package created on Github​
  • Validation resource for Hepatotox R package identified
  • Finalise Stage 2 white paper​
  • Finalise R Package Hepatotox tool for Stage1 white paper​
  • Embark on Hepatotox R package for Stage 2 white paper



Objectives & Deliverables

Timelines 
White PaperQ4 2023

Finalise Stage 2 of draft White Paper