Project Scope |
Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:
Development of new standards is not in scope, and any impact findings that may necessitate new standard development will be shared with CDISC for their consideration. Examples may be created on how to implement the framework by using permitted extensions to the existing data standards. |
| Project Leads | |
| Chris Price (Roche) | |
| Lori VanMeter (Janssen Research & Development) | lvanmet@ITS.JNJ.com |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
Review current company practices
Develop conference abstract
Draft paper
Conference slides
Final White Paper ready for Public Review
Publish White Paper
Submit abstracts for multiple conferences | Q2 2023 |
Develop draft White Paper for internal project review prior to PHUSE Working Group Review and Public Review | Q3 |
| 2023 |
| |||||||
Working on a White Paper | |||||||
| Project Members | Organisation |
|---|---|
| Ashik Chowdhury | Cytel |
| Alexandra Cochinaire | Johnson & Johnson |
| Arman Sabbaghi | Purdue University |
| Armin Schueler | Merckgroup |
| Banoo Madhanagopal | Bayer |
Benoît Sansas | Pierre Fabre |
| Bess Leroy | CDISC |
| Brent Burger | Jazz Pharma |
| Cedric Davister | Merck |
| Dan Checketts | Jazz Pharmaceuticals |
| Dong Xi | Gilead |
| Edwin van Stein | GSK |
| Elena Polverejan | Janssen Research & Development |
| Elisa Gomez | Eli Lilly and Company |
| Emilea Norris | CDISC |
| Fatma Zohra | Tigermed |
| Federica Brunero | PPD |
| Irfan Ali | Tigermed |
| Jennifer, Britt | Gilead |
| John Scott | FDA |
| Jonathan Siegel | Bayer |
| Jozef Aerts | XML4Pharma |
| Junxiang Luo | Moderna |
| Kevin Liu | Pfizer |
| Kirti Bhatt | Tigermed |
| Kim Musgrave | Amgen |
| Project Members | Organisation |
|---|---|
| Lauren Shinaberry | Abbvie |
| Liping Sun | FDA |
| Lisa Lin | FDA |
| Marc Walton | Janssen Research & Development |
| Marian Mitroiu | Biogen |
| Matt Baldwin | Amgen |
| Mindy Mo | Bayer |
| Munish Mehra | Tigermed |
| Naga Dontamsetty | Takeda |
| Nikhil Sudarshan | Jazz Pharmaceuticals |
| Nilani Liyanage | Jansen Research & Development |
| Oliver Wirtz | Bayer |
| Rama Empati | AstraZeneca |
| Rama Kalyanamma | ICON |
| Rhian Jacob- Moffatt | Roche |
| Robin White | Eli Lilly and Company |
| Rosanne Lane | Janssen Research & Development |
| Samson Ghebremariam | Novartis |
| Santosh K Lingala | Gilead |
| Shahida Tamboli | Labcorp |
| Stephen Ruberg | Analytix Thinking |
| Steve Gilbert | Pfizer |
| Steve Wilson | FDA |
| Sonali Ambure | Tigermed |
| Sudhakar Bollineni | Tigermed |
Sujitha Susan John | Novo Nordsik |
| Venkat Gajji | Tigermed |
| Vidya Jayapalan | Takeda |
| Xiaohan Zou | Bristol Myers Squibb |
| Yongming Qu | Eli Lilly and Company |
| Yun Peng | Bristol Myers Squibb |
| Zongjun Zhang | Eli Lilly and Company |