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. |
Q2 2023
Timelines
Project Leads | |
---|---|
Melvin Munsaka (, AbbVie) | |
Terry Walsh (, Astellas) |
Objectives & Deliverables
Finalise stage 1 of draft White Paper for Public Review
Nicola Newton, PHUSE Project Assistant |
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 |