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Version 10
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Project ScopeAssess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required
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Team continue to provide responses to questions received. They are also looking at how they can evolve |
Project Members | Company |
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Achim Klotz | Roche |
Aiming Yang | Merck |
Ajay Gupta | PPDI |
Amy Adyanthaya | Biogen |
Angelica Hoch | JNJ |
Anne Lindberg | Roche |
Annette Travalent | Lilly |
Arvind Sri Krishna Mani | Zifornd |
Audrey Yu | JNJ |
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 | ITS JNJ |
Grace Feng | BMS |
Hans Peter - Schreiter | Entimo |
Harsha Anantanardhan | Pfizer |
Helena Sviglin | FDA |
Himaja Surapaneni | Chiltern |
IIse Augustyns | JNJ |
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 | Independent |
Joosep Raudsik | Statfinn |
Julie Maynard | JNJ |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | InventivHealth |
Katherine Xie | Abbvie |
Kathy Knuckles | Lilly |
Keith Hibbetts | Lilly |
Kelly Mewes | Roche |
Ken Stoltzfus | Accenture |
Kiran Bonda | Inventiv Health |
Kiran Kumar Kundarapu | Merck |
KiranKumar Padhiar | JNJ |
Koichi Yamaguchi | Lilly |
Kristie Kooken | Achaogen |
Kristin C Kelly | pinnacle 21 |
Project Members | Company |
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Lakshmi Mallela | ITS JNJ |
Laura Bellamy | PPDI |
Laura Schonwalder | Triangle Biostatistics |
Liekie Gijsbers | OCS |
Magdalena Wojciechowska | Roche |
Majdoub Haloui | Merck |
Marguerite Kolb | ITS JNJ |
Marjorie Nowak | Novartis |
Marleen Nijs | ITS JNJ |
Mathias Lebreton | Novartis |
Nancy Brucken | CSG |
Natalia Jacquet | Phastar |
Nate Freimark | The Griesser Group |
Naveed Khaja | Independent |
Olga Vovk | NIH |
Peter Van Reusel | CDISC |
Pritesh Solanki | Merck |
Rabia Ahmad | GSK |
Ramachandran Radhakrishanan | Merck |
Raman Bassi | Bayer |
Remesh Kavicharla | CRC Pharma |
Robert Stemplinger | Industry |
Rui Li | FDA |
Ruth Alonso | Chiltern |
Sairam Gorthi | JNJ |
Sameer Saxena | Bayer |
Shravan Kv | datafoundry |
Shravan KV | Data Foundry |
Silke Hochstädter | Abbie |
Soumya Rajesh | Amgen |
Srinivasa Pillarisetty | Astrazeneca |
Srinivasa Rao Mandava | Industry |
Sterling Hardy | BMS |
Ta Jen Chen | FDA |
Tiffany Tian | Industry |
Tina Gursahani | Industry |
Trevor Mankus | Industry |
Unnat Patel | Pfizer |
Vanessa Sarrechia | JNJ |
Veena Nataraj | Shire |
Veerie Coenen | ITS JNJ |
Venkata Peri | JNJ |
Vishnu Kollisetti | PPDI |
Wei Lin | FDA |
Weiya Zhang | FDA |
Wioletta Schulze | Grunenthal |
Yan Lei | ITS JNJ |
Yoshiko Kitagawa | Industry |
Zhongwei Zhon | Pfizer |