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Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Session Chair(s)
Yuki Ando, PhD
Principal Senior Scientist for Biostatistics
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
This session will discuss how to promote utilization of innovative methodologies such as M&S and Bayesian approach for efficient drug development. Regulators will present their recent activities for reviewing/qualifying innovative methodologies and share their experiences.
Learning Objective : Identify how to recognize innovative methodologies recently applied for efficient new drug development and related activities in regulatory agencies aiming at accelerating drug development; Discuss how to consider the use of such methodologies in drug development through better communication between industry and regulatory agencies.
Speaker(s)
Utilization and Evaluation of Innovative Methodologies: PMDA Perspective
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Extrapolation: Recent European Regulatory Considerations
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
Model-Based Bayesian Methods in Pharmaceutical Clinical Trials
Neal Thomas, PhD
Pfizer Inc, United States
Executive Director, Biostatistics
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