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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

114 * ! Mon, 7/29/2019, 8:30 AM - 10:20 AM CC-108
Applying the ICH E9(R1) Addendum: Practical Considerations in Choosing Estimands, Estimators, and Sensitivity Analyzes — Topic Contributed Papers
Biopharmaceutical Section, ENAR, WNAR
Organizer(s): Pilar Lim, PhD, Janssen Research & Development, LLC
Chair(s): Pilar Lim, PhD, Janssen Research & Development, LLC
8:35 AM Descending from the Theoretical to the Practical: Our Journey from Clear Definition to Messy Inference and Back

Michael O'Kelly, IQVIA
8:55 AM How Should We Select and Define Trial Estimands? – Examples Based on a Disease State

Elena Polverejan, Johnson & Johnson-Janssen R&D
9:15 AM Implementation of Estimand Framework in Oncology Clinical Trials

Kalyanee Appanna, Novartis Pharmaceutical Corporation; Bharani Dharan, Novartis Pharmaceuticals; Yuanbo Song, Novartis Pharmaceutical Corporation; Ekkehard Glimm, Novartis Pharma AG
9:35 AM Lessons Learned from Implementing ICH E9 in Phase 2 Trials Across Multiple Therapeutic Areas

Jared Christensen, Pfizer Research
9:55 AM Discussant: Craig Mallinckrodt, PhD, Biogen
10:15 AM Floor Discussion