Analyses & Displays for Hepatotoxicity

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 Leads	Email
Melvin Munsaka	melvin.munsaka@abbvie.com
Terry Walsh	terry.walsh@astellas.com
Paula Rowley (PHUSE Project Assistant)	paula@phuse.global

CURRENT STATUS Q22021
New team formed and are now aligned on objectives. They are started to draft their White Paper and is currently in progress. Due to availability of key members, progress has been slower than planned. If you would like to join this project, email: workinggroups@phuse.global

Objectives & Deliverables	Timelines
Draft document for review	Q32021
Users Guide or White Paper	Q32021

Project Members	Organisation
Amelia Pang	Sanofi
Charles Beasley	MSN
Darshan Bhatt	Industry
Eileen Navarro Almario	FDA
Hongli Lu	Merck
John Marciank	AbbVie
Patrick Hannon	MMS
Paul Hayashi	A2 Healthcare Corporation
Preeti Venkataraman	FDA
Swarnalatha Reddy	Industry
Veronical Pei Yang	FDA
William Palo	AbbVie
Shayami	Eli Lilly

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Analyses & Displays for Hepatotoxicity