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Project ScopeCollect frequently asked questions (FAQs) from Industry. If you have a question for the team, email workinggroups@phuse.globalAssess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required
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This project initiated the first 'Expert Answers to Community Questions' Panel which had members from FDA, CDISC and Industry present on Data Submissions. You can find the recording here and the blog here. |
Project Members | Company |
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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 |
Himaja Surapaneni | Chiltern |
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 |
Joosep Raudsik | Statfinn |
Julie Maynard | Janssen Research & Development |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | Syneos Health |
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 |
Kristie Kooken | Achaogen |
Kristin C Kelly | Pinnacle 21 |
Project Members | Company |
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Lakshmi Mallela | Janssen Research & Development |
Laura Bellamy | PPDI |
Laura Schonwalder | Triangle Biostatistics |
Liekie Gijsbers | OCS Life Sciences |
Magdalena Wojciechowska | Roche |
Majdoub Haloui | Merck |
Marguerite Kolb | Janssen Research & Development |
Marjorie Nowak | Novartis |
Marleen Nijs | Janssen Research & Development |
Mathias Lebreton | Novartis |
Méhadjia 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 |
Shravan Kv | Data Foundry |
Silke Hochstädter | Abbie |
Soumya Rajesh | Amgen |
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 | 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 |