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INAUGURAL STATISTICAL INNOVATION COMMUNITY SUMMIT
WORKSHOP AGENDA THURSDAY, NOVEMBER 9, 2023 |
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8:00 AM - 8:45 AM
Registration & Breakfast |
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8:45 AM - 9:00 AM
Opening Remarks |
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9:00 AM - 11:30 AM
Keynote Session Maximizing the Impact of Innovative Statistical Methods in Partnership with Health Agencies Chair Bret Musser Regeneron Keynote Speakers John Scott FDA (Virtual) Statistical Innovation in Regulatory Science: Review and Research Jose Pinheiro Johnson & Johnson Regulatory Qualification of a Statistical Methodology: the MCP-Mod Story Ying Yuan University of Texas MD Anderson Cancer Center Model-assisted Trial Design: Keep It Simple and Smart! Neal Thomas Independent Consultant Dose-finding with Emax Modeling: Experience with FDA Methodology Qualification |
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11:30 AM - 12:30 PM
Lunch & Networking |
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12:30 PM - 1:45 PM
Session I Statistical Innovation in Action Chair Fang Liu Merck Panel Discussants Haoda Fu (Eli Lilly) Binbing Yu (AstraZeneca) Inna Perevozskaya (GSK) Jian Zhu (Servier) Li Wang (AbbVie) Jiawen Zhu (Genentech) |
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1:45 PM - 2:00 PM
Break |
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2:00 PM - 3:15 PM
Session II Integrating Statistical Innovation in Healthcare Organizations Chair Elena Polverejan Johnson & Johnson Panel Discussants Ron Yu (Gilead Sciences) Kentaro Takeda (Astellas) Jose Pinheiro (Johnson & Johnson) May Mo (Amgen) Yongming Qu (Eli Lilly) Demissie Alemayehu (Pfizer) David Ohlssen (Novartis) |
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3:15 PM - 3:30 PM
Break |
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3:30 PM - 4:45 PM
Session III Strengthening the Statistical Innovation Community Chair Jinglin Zhong Sumitomo Pharma America Panel Discussants Andres Sirulnik (Regeneron) Olga Marchenko (Bayer) Minghui Chen (University of Connecticut) Lei Nie (FDA) Claude Petit (Astellas) Ram Tiwari (Bristol Myers Squibb) |
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4:45 PM - 5:00 PM
Closing Remarks |