Project 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 | |
|---|---|
Zachary Skrivanek (Eli Lilly) | |
Xiangyun 'Sharon' Wang (Genentech) | |
Raj kirann Boddu (Takeda) | |
Paula Rowley (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
|---|---|
| Complete the Docker POC Project | On hold |
| Kick off the Docker pilot for a real submission | On hold |
White Paper on best practices for interactive analyses for decision making & submissions | 2023 |
CURRENT STATUS Q1 2023 |
|---|
Aim to promote the use of ARDS (Analysis Results Datasets) as a solution to address validation and reproducibility for including interactive data display in submission. Eli Lilly plans to pilot interactive data display in submission with PDMA as the next step. |
| Published Deliverables |
|---|
Best Practice for Interactive Analysis for Submission – CSS Poster 2020 DevOps in Action, Containers@Bayer- Presentation by Karl Brand 21-03-19 Interactive Data Visualisations for Decision Making in Submissions – PHUSE Webinar Wednesday 2019 |
Project Members | Organisation |
|---|---|
| Ari Siggaard Knoph | Novo Nordisk |
| Bhavin Solanki | Bayer |
| Darshan Bhatt | Industry |
Catherine Xiao | Gilead |
Douglas Warfield | FDA |
Eric Herbel | Integrated Clinical Systems |
Gaoyang Li | Bayer |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
Karan Dheer | SAS |
Karl Brand | Bayer |
| Kapil Anand | Parexel International |
| Kelci Miclaus | Industry |
| Lixiao Chen | Bristol Myers Squibb |
| Mark Marino | Mark T Marino Consulting |
| Maria Dalton | Industry |
Project Members | Organisation |
|---|---|
Mary Nilsson | Eli Lilly |
| Mominul Islam | Sarepta Therapeutics |
Nagadip Rao | Eliassen Group |
| Parag Wani | Novo Nordisk |
Phil Bowsher | RStudio |
| Pinaki Biswas | Pfizer |
| Ramesh Venkataramana | GENINVO |
Raj Kiran Boddu | Takeda |
Rinki Jajoo | Merck |
Shiva Katepilli | Sunovion Pharmaceuticals |
Suhas Ravindra | GSK |
Sucharita Pilli | Novo Nordisk |
| Sumeet Uppal | Regeneron Pharmaceuticals |
| Vineet Mathur | Bristol Myers Squibb |
| Vineet Sharma | Sarpeta |
Vishal Shah | Sunovion Pharmaceuticals |
Wei Wang | Eli Lilly |
Yang Yu | Sunovion Pharmaceuticals |