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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

Terry Walsh

Wendy Dobson (PHUSE Project Manager)

melvin.munsaka@abbvie.com

Terry Walsh

terry.walsh@astellas.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse

Wendy@phuse

.eu

Deliverables	Timelines

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