Legend: CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
Activity Details
496 * !
Wed, 7/31/2019,
10:30 AM -
12:20 PM
CC-603
Estimand Framework and Its Impact on Drug Development in Oncology — Topic Contributed Papers
Lifetime Data Science Section , Biopharmaceutical Section, Biometrics Section
Organizer(s): Evgeny Degtyarev, Novartis ; Kaspar Rufibach, F. Hoffmann-La Roche
Chair(s): Rui Tang, Servier
10:35 AM
Estimand Framework in Oncology Drug Development – Impact and Opportunities
Evgeny Degtyarev, Novartis ; Kaspar Rufibach, F. Hoffmann-La Roche; Jonathan Siegel, Bayer HealthCare Pharmaceuticals Inc.; Viktoriya Stalbovskaya, Merus; Steven Sun, J&J
10:55 AM
Importance of Censoring Mechanisms in Selecting Appropriate Estimands
Jonathan Siegel, Bayer HealthCare Pharmaceuticals Inc. ; Michelle Casey , Pfizer; Hans-Jochen Weber, Novartis; Anja Schiel, EMA BSWP/SAWP; Stefan Englert, AbbVie Deutschland GmbH & Co KG; Steven Sun, J&J; Kaspar Rufibach, F. Hoffmann-La Roche
11:15 AM
Sensitivity Analysis Vs Supportive Analysis Under Estimand Framework: a Case Study in Hematological Malignancies
Steven Sun, J&J ; Hans-Jochen Weber, Novartis; Marie-Laure Casadebaig, Celgene; Emily Butler, GlaxoSmithKline; Satrajit Roychoudhury, Pfizer Inc ; Kaspar Rufibach, F. Hoffmann-La Roche; Viktoriya Stalbovskaya, Merus
11:35 AM
Estimand Framework – Are We Asking the Right Questions? a Case Study in the Solid Tumor Setting
Michelle Casey , Pfizer ; Evgeny Degtyarev, Novartis ; Maria Jose Lechuga, Pfizer, Inc.; Paola Aimone, Novartis Pharma AG; Feng Feng Liu, AstraZeneca; Viktoriya Stalbovskaya, Merus; Rui Tang, Servier; Emily Butler, GlaxoSmithKline; Oliver Sailer, Boehringer Ingelheim Pharma GmbH & Co
11:55 AM
Discussant: Kunthel By, Division of Biometrics V, OB/OTS/CDER FDA
12:15 PM
Floor Discussion
