Project Scope The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, China FDA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to:
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| Project Leads | |
|---|---|
| Aatiya Zaidi (Gilead) | aatiya.zaidi@gilead.com |
| Amy Palmer (CDISC) | |
| Bhavin Busa (Vita Data Sciences) | bhavinbusa@gmail.com |
| Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
| Objectives & Deliverables | |
|---|---|
Publish responses to questions received under: | Ongoing |
| ||||||
|---|---|---|---|---|---|---|
| Continuing to receive and answer questions. Responses are published to the PHUSE Advance Hub. |
| Published Deliverables | Date |
| Integration Strategies in Support of ISS/ISE Submissions: Version 1.0 | 27-Oct-2020 |
| Best Practices for Submissions of Event Adjudication: Version 1.0 | 02-Dec-2019 |
| Project Members | Organisation |
| Aatiya Zaidi | Gilead |
| Achim Klotz | Roche |
| Aiming Yang | Merck |
| Ajay Gupta | PPDI |
| Amy Adyanthaya | Biogen |
| Angelica Hoch | Janssen Research & Development |
| Anne Lindberg | Roche |
| Annette Travalent | Eli Lilly |
| Arvind Sri Krishna Mani | Zifornd |
| Athenkosi Nkonyeni | Industry |
| Audrey Yu | Janssen Research & Development |
| Brian Harris | MedImmune |
| Colleen Ratliffe | FDA |
| Cristina Do Carmo | Novartis |
| Cynthia Stroupe | UCB |
| Diane Wold | CDISC |
| Dorothy Dlamini | Bayer |
| Doug Warfield | FDA |
| Elizabeth Langevin | Takeda |
| Farhan Hameed (CJ) | Pfizer |
| Gloria Jones | Janssen Research & Development |
| Grace Feng | BMS |
| Hans Peter - Schreiter | Entimo |
| Harsha Anantanardhan | Pfizer |
| Helena Sviglin | FDA |
| IIse Augustyns | Janssen Research & Development |
| Jack Zhang | FDA |
| Jade Chen | FDA |
| Janet Roich | Amgen |
| Jee Run Lee | FDA |
| Jeffry Florian | FDA |
| Joanne Zhou | GSK |
| Johannes Ulander | S-cubed |
| John Bielinski | Industry |
| Julie Maynard | Janssen Research & Development |
| Kajal Tahiliani | Cytel |
| Kamiar Mike Hamidi | Merck |
| Kannan Nagureddi | Amgen |
| Kapila Patel | IQVIA |
| Katherine Xie | AbbVie |
| Kathy Knuckles | Eli Lilly |
| Keith Hibbetts | Eli Lilly |
| Kelly Mewes | Roche |
| Ken Stoltzfus | Accenture |
| Kiran Bonda | Syneos Health |
| Kiran Kumar Kundarapu | Merck |
| KiranKumar Padhiar | Janssen Research & Development |
| Koichi Yamaguchi | Eli Lilly |
| Huaifeng Wang | Haisco |
| Inayath Ali | Parexel |
| Maria Dalton | Takeda |
| Project Members | Organisation |
| Kristie Kooken | Achaogen |
| Kristin C Kelly | Pinnacle 21 |
| Lakshmi Mallela | Janssen Research & Development |
| Laura Bellamy | PPD |
| Laura Schonwalder | Triangle Biostatistics |
| Liekie Gijsbers | OCS Life Sciences |
| Magdalena Wojciechowska | Roche |
| Majdoub Haloui | Merck |
| Marguerite Kolb | Janssen Research & Development |
| Marleen Nijs | Janssen Research & Development |
| Mathias Lebreton | Novartis |
| Mehadjia Mahboub | Sanofi |
| Nancy Brucken | CSG |
| Natalia Jacquet | PHASTAR |
| Nate Freimark | The Griesser Group |
| Naveed Khaja | Industry |
| Olga Vovk | NIH |
| Pritesh Solanki | Merck |
| Ramachandran Radhakrishanan | Merck |
| Raman Bassi | Bayer |
| Remesh Kavicharla | CRC Pharma |
| Robert Stemplinger | Industry |
| Rui Li | FDA |
| Ruth Alonso | Chiltern |
| Sairam Gorthi | Janssen Research & Development |
| Sameer Saxena | Bayer |
| Shivaram Nagabhushana Sharma | ICON DOCS |
| Shravan Kv | Data Foundry |
| Silke Hochstädter | AbbVie |
| Soumya Rajesh | Amgen |
| Sreekanth Reddy Yasa | IQVIA |
| Srinivasa Rao Mandava | Industry |
| Sterling Hardy | Bristol Myers Squibb |
| Ta Jen Chen | FDA |
| Tiffany Tian | Industry |
| Tina Gursahani | Industry |
| Trevor Mankus | Industry |
| Unnat Patel | Pfizer |
| Vanessa Sarrechia | Janssen Research & Development |
| Veena Nataraj | Shire |
| Veerie Coenen | Janssen Research & Development |
| Venkata Peri | Janssen Research & Development |
| Vishnu Kollisetti | PPDI |
| Wei Lin | FDA |
| Weiya Zhang | FDA |
| Wioletta Schulze | Grünenthal |
| Yan Lei | Janssen Research & Development |
| Yoshiko Kitagawa | Industry |
| Zhongwei Zhon | Pfizer |
| Winkle Lu | Industry |