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 | |
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Melvin Munsaka (AbbVie) | |
Terry Walsh (Astellas) | |
Nicola Newton (PHUSE, Project Assistant) |
Objectives & Deliverables | Timelines | |||||
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Finalise stage 1 of draft White Paper for Public Review | Q2 2023 | |||||
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Working on a White Paper | ||||||
Project Members | Organisation | |||||
Amelia Pang | Sanofi | |||||
Charles Beasley | MSN | |||||
Darshan Bhatt | Industry | |||||
Eileen Navarro Almario | FDA | |||||
Hongli Lu | Merck | |||||
John Landry | Eli Lilly | |||||
John Marciank | AbbVie | |||||
Patrick Hannon | MMS | |||||
Paul Hayashi | A2 Healthcare Corporation | |||||
Preeti Venkataraman | FDA | |||||
Shayami | Eli Lilly | |||||
Swarnalatha Reddy | Industry | |||||
Veronical Pei Yang | FDA | William Palo | AbbVie
Objectives & Deliverables | Timelines |
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Finalise stage 1 of draft White Paper for Public Review | Q2 2023 |