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 | |
---|---|
Melvin Munsaka |
, AbbVie |
Terry Walsh |
, Astellas |
Nicola Newton, PHUSE Project Assistant |
Objectives & Deliverables
Q2 2023 | William Palo | AbbVie
| ||||||
---|---|---|---|---|---|---|---|---|
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 | |||||||
Q3 2024 | ||||||||
|
Objectives & Deliverables | Timelines |
---|---|
Finalise Stage 1 of draft White Paper | Q4 2023 |