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Clinical Trial Simulations and Modeling
Session Chair(s)
David A. Amato
Vice President, Biometrics and Data Management
Vertex Pharmaceuticals, United States
Regulatory agencies are not only now recognizing the use of clinical trial simulation in the drug development process as an effective trial design and outcome prediction tool, but are actively collaborating with biopharmaceutical clinical trialists in an effort to make available new and promising drugs to patients sooner. This transformative and collaborative way of developing new therapies has the potential to enable timely knowledge-based decision making and translate into more high-value therapies through increased development efficiencies. This session will explore some of the potential benefits of clinical trial simulation practices throughout the drug development process with expert speakers from the biopharmaceutical industry.
Learning Objective : Describe potential benefits of clinical trial simulation practices in the drug development process; Explain how clinical trial simulation can be used as an effective trial design and outcome prediction tool.
Speaker(s)
Experiences with Using Clinical Trial Simulation and Modeling at the Program Level
Nitin R. Patel, PhD, MBA
Cytel Inc., United States
Founder, Chairman and Chief Technology Officer
Simulation Guided Clinical Trial Design: Does It Improve the Final Design?
J. Kyle Wathen, PhD, MS
Cytel Inc., United States
Vice President, Scientific Strategy and Innovation
A Practical Perspective on Clinical Trial Simulations for the Treatment of Hepatitis C
Eric Haseltine, PhD
Vertex Pharmaceuticals, United States
Research Scientist
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