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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)

Terry Walsh (Astellas Pharma)

Katie Warren (PHUSE Project Assistant) 

Objectives & Deliverables

  • Draft of the initial scope (Stage 1) White Paper 


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