Project Scope |
Best Practices in Data Standards Implementation Governance will cover the following areas:
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Project Leads | |||
Ellen Asam | (Merk), Merck | ellen_asam@merck.com | |
Sandy VanPelt Nguyen | (, Pfizer | )||
Nicola Newton, PHUSE Project Assistant | )katie@phuse |
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Objectives & Deliverables | Timelines | ||||||||
Survey | Q1 2022 | ||||||||
Summarise survey results in a White Paper | Q2/3 2022 | ||||||||
Poster at PHUSE/FDA CSS | Q3 2022 | ||||||||
Publish White Paper | Q1 2023 | ||||||||
| Aiming to complete analysis by Q1 | 2023||||||||
Project Members | Organisation | ||||||||
Aatiya Zaidi | Gilead | ||||||||
Aimee Basile | Surface Oncology | ||||||||
Brook (Amanda) Hinkson | Merck | ||||||||
Carlo Radovsky | Immanant | ||||||||
Cathy Yang | Roche | ||||||||
Gayathri Mahadevan | Cytel | ||||||||
Gina Wood | eClinical Solutions | ||||||||
Jennifer Jarvis | Eli Lilly | ||||||||
Junying Zhang | Gilead | ||||||||
Kapil Anand | Parexel | ||||||||
Ligia Kilinski Cevasco | Jazz Pharmaceuticals | ||||||||
Matt Baldwin | Amgen | ||||||||
Nicholas Pemble | Johnson & Johnson | ||||||||
Parisa Osivand Pour | Industry | ||||||||
Priyanka Pollarine | Biogen | ||||||||
Ramaiah Muvvala | Inductive Quotient | ||||||||
Ranvir Singh | Labcorp | ||||||||
Rie Ichihashi | Sanofi | ||||||||
Rony Ye | EBSI | ||||||||
Sathesh Avvaru | PPD | ||||||||
Susan Takas | Johnson & Johnson | ||||||||
Tingting Tian | Regeneron | ||||||||
Titania Dumas-Roberson | Unither Pharmaceuticals | ||||||||
Todd Bazin | Biogen | Torsten Petsching | Boehringer Ingelheim|||||||
2024 | |||||||||
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Objectives & Deliverables | Timelines |
Publish White Paper | Q4 2023 |
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedback | Q3 2023 |