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Opportunities for Efficient and Innovative Study Designs
Session Chair(s)
Amy Xia, PHD
Vice President, Center for Design and Analysis
Amgen Inc., United States
Drug development has been facing both opportunities and challenges. On one hand, a variety of discovery technologies have helped drive growth in the drug development pipeline. On the other hand, the biopharmaceutical industry has had to manage a challenging operating environment characterized by increasing costs, inefficient and lengthy cycle times, and high levels of risk, uncertainty, and complexity. More efficient and innovative study designs have the great potential of improving success rates and optimizing clinical trial performance and data quality.
This session will review and discuss opportunities for efficient and innovative study designs with some real world examples in the areas of effective and efficient phase 2 study design, leveraging natural history data for rare diseases drug development, and use of innovative Bayesian designs for non-inferiority studies.
Learning Objective : Evaluate case studies in efficient and innovative study designs; Discuss challenges and opportunities in innovative designs and analyses.
Speaker(s)
Understanding the Special Importance of Phase 2 Clinical Studies
Ron Marks, PHD
Clinipace Worldwide, United States
Chief Scientific Officer
Leveraging Natural History Data for Rare Diseases Drug Development: A Bayesian Perspective
Shu Han, PHD, MBA
Moderna Therapeutics, United States
Head of Biostatistics
A Bayesian Approach in the Non-Inferiority Setting
Cristiana Mayer, DRSC, PHD
Johnson & Johnson Vision, United States
Head of Biostatistics