| Scope |
|---|
Leverage Visual Analytics in our submission package to improve interactions between regulatory agencies and sponsors for a fast and effective review of submitted data and analyses. |
Project Leads | |
|---|---|
Xiangyun 'Sharon' Wang | wang.xiangyun@gene.com |
Zachary Skrivanek | skrivanek_zachary@lilly.com |
Key Milestones
| Objective | Timeline |
|---|---|
| Complete the Docker POC Project | Q4 2020 |
| Kick off the Docker pilot for a real submission | Q4 2020 |
White Paper on best practices for interactive analyses for decision making & submissions | Q4 2020 |
CURRENT STATUS
Continuing to write the White Paper, awaiting feedback from the FDA on the POC submission.
Project Members
| Name | Organisation |
|---|---|
Catherine Xiao | Gilead |
Douglas Warfield | Ireview |
Eric Herbel | Industry |
Gaoyang Li | Bayer |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
Karl Brand | Bayer |
| Maria Dalton | GSK |
Mary Nilsson | Eli Lilly |
| Mominul Islam | Sarepta |
Nagadip Rao | Elissen |
Project Members
| Name | Organisation |
|---|---|
Phil Bowsher | Rstudio |
Raj Kiran Boddu | Takeda |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
Rinki Jajoo | Merck |
Shiva Katepilli | Sunovion Pharmaceuticals |
Vishal Shah | Sunvion |
Wei Wang | Eli Lilly |
Yang Yu | Sunovion |
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.