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 |
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 2023 |
|
Q3/4 2022 | |
|
Project Members | Organisation |
---|---|
Ashik Chowdhury | Cytel |
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 |
Fatma Zohra | Tigermed |
Federica Brunero | PPD |
Helle Lynggaard | Novo Nordisk |
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 |
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 |
Randi Mcfarland | Ephicacy |
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 |