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62 * ! | Sun, 8/9/2015, 4:00 PM - 5:50 PM | CC-612 | |
Challenges and Opportunities for Enrichment Design of Clinical Trials — Topic Contributed Papers | |||
Biopharmaceutical Section , Biometrics Section | |||
Organizer(s): Xiaolong Luo, Celgene, Lanju Zhang, AbbVie | |||
Chair(s): Lanju Zhang, AbbVie | |||
4:05 PM | Adaptive Biomarker Population Selection in Phase III Confirmatory Trials — Xiaoyun Li, Merck ; Cong Chen, Merck Research Laboratories | ||
4:25 PM | A Bootstrap Test Procedure for Treatment-Biomarker Interaction in Phase III Clinical Trials — Bingshu Chen, Queens University ; Wenyu Jiang, Queen's University | ||
4:45 PM | Enrichment Design for Targeted Therapy — Bo Yang, AbbVie Pharmaceutical Research & Development ; Yijie Zhou, AbbVie ; Lanju Zhang, AbbVie ; Lu Cui, AbbVie | ||
5:05 PM | Regulatory Challenges in Reviewing Targeted Therapy Trial — Kun He, DBV/OB/CDER/FDA ; Rajeshwari Sridhara, FDA | ||
5:25 PM | Discussant: Xiaolong Luo, Celgene | ||
5:45 PM | Floor Discussion |
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