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Project Scope

This project team will create a 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
Wendy Dobson (PHUSE Project Manager)	wendy@phuse.eu

Status

colour	Blue
title	Current Status

Q42020

New team formed and kick off meeting taken place. Presented at the recent CSS

Deliverables	Timelines

Project Members	Company
Amelia Pang	Sanofi
Eileen Navarro Almario	FDA
John Marciano	AbbvieAbbVie
Patrick Hannon	MMS HoldingsMMS
Preeti Venkataraman	FDA
Swarnalatha Reddy	Covance
Veronical Pei Yang	FDA
William Palo	Abbvie