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Session 5: Modeling and Simulation in Drug Development: How Do Statisticians Participate and Impact on It?
Session Chair(s)
Peiling Yang, PHD
Supervisory Mathematical Statistician
FDA, United States
Cristiana Mayer, DRSC, PHD
Head of Biostatistics
Johnson & Johnson Vision, United States
This session will discuss and illustrate the potential roles and contributions of statisticians in Modeling and Simulation (M&S) activities at various stages of clinical development programs. It will include two short case study presentations: one on the use of M&S for bridging dose regimens in a successful NDA submission and the other focusing on M&S to assist the design of a dose finding trial, followed by a panel discussion.
Speaker(s)
Model-based Bridging of Dose Regimens to Avoid Additional Studies and Accelerate Approval: A Case Study in Type 2 Diabetes
Jose C. Pinheiro, PHD
Janssen Research & Development, LLC, United States
Head of Statistical Modeling and Methodology, SDS
Program Level Modeling and Simulation of Phase 2 to Registration – Overview and Case Studies
Bill R. Prucka, PHD
Eli Lilly and Company, United States
Director, Innovation Computational Statistics
Panelist (joining the Speakers)
Bjoern Bornkamp, PHD, MSC
Novartis Pharma AG, Switzerland
Senior Director, Statistical Methodology
H. M. James Hung, PHD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
Dionne Price, PHD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER