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Topic-Contributed Paper Session

Seamless late-stage development in oncology – the past decade in practice

Thu, Aug 10, 8:30 AM

Philip HeOrganizerFeifang HuChair

Biometrics Section

4 Presentations

Use of seamless study designs for registrational purposes in oncology clinical development

8:35 AM - 8:55 AM

Co-authors: Philip He, Guozhi Gao, Freda Cooner (Eli Lilly and Company), Lei Gao (Moderna), Gautier Paux (Sanofi), Kristine Broglio (AstraZeneca), Wei He (GSK)

Adaptive Seamless Design in Late-Phase Oncology Development – A Systemic Meta-Analysis of Real Clinical Cases

8:55 AM - 9:15 AM

Freda Cooner (Eli Lilly and Company)

Co-authors: Kristine Broglio (AstraZeneca), Philip He, Marina Lowen (Astrazeneca), Izuagie Popoh Attairu Ikhapoh (Astrazeneca), Feng Xiao (Daiichi Sankyo), Lei Gao (Moderna), Yujun Wu (Takeda)

Case Study – 2-in-1 design in oncology and considerations

9:15 AM - 9:35 AM

Co-authors: Cong Chen (Merck & Co., Inc.), Yixin Ren (Merck)

Discussions and Challenges in Multi-Arm Multi-Stage (MAMS) Designs

9:35 AM - 9:55 AM

Niladri Roy Chowdhury (Bristol Myers Squibb)

Co-authors: Xue Wu (Pennsylvania State University), Arun Kumar (Bristol Myers Squibb), Kaushal Mishra, Ram Tiwari (Bristol Myers Squibb), Kalyanee Viraswami-Appanna (Bristol Myers Squibb)

Discussant

Thomas Gwise

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