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 (Johnson & Johnson) | lvanmet@ITS.JNJ.com |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
Kick off
Review current company practices |
| Q1 2022 |
Develop conference abstract |
| Q2 2022 |
Draft |
paper | Q3 2022 |
Conference slides |
| Q4 2022 |
Final |
White Paper ready for Public Review | Q4 2022 |
Publish White Paper | Q1 |
Final paper published
| 2023 |
| |||||||
Q2/3 2022 | |
|
| Project Members | Organisation |
|---|---|
| Alexandra Cochinaire | Johnson & Johnson |
| Ann M Pennington | Pfizer |
| 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 |
| Helle Lynggaard | Novo Nordisk |
| Jennifer, Britt | Gilead |
| John Scott | FDA |
| Jonathan Siegel | Bayer |
| Jozef Aerts | XML4Pharma |
| Junxiang Luo | Moderna |
| Kevin Liu | Pfizer |
| Kim Musgrave | Amgen |
| Project Members | Organisation |
|---|---|
| Liping Sun | FDA |
| Lisa Lin | FDA |
| Marc Walton | Janssen Research & Development |
| Matt Baldwin | Amgen |
| Mindy Mo | Bayer |
| Munish Mehra | Tigermed |
| Nikhil Sudarshan | Jazz Pharmaceuticals |
| Nilani Liyanage | Jansen Research & Development |
| Oliver Wirtz | Bayer |
| Rama Empati | AstraZeneca |
| 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 |
Sujitha Susan John | Novo Nordsik |
| 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 |