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DIA 2018 Global Annual Meeting


Opportunities for Efficient and Innovative Study Designs

    Session Chair(s)
      Amy  Xia, PhD

      Amy Xia, PhD

      • Executive Director, Biostatistics
      • 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 : Have a better understanding of Phase 2 research design Utilize this understanding to design more informative Phase 2 research studies Utilize results from Phase 2 studies to enhance your Phase 3 clinical trial design and find more confidence in the ultimate success of your Phase 2 clinical trials
    Speaker(s)
      Ron  Marks, PhD

      Understanding the Special Importance of Phase 2 Clinical Studies

      Ron Marks, PhD

      • Chief Scientific Officer
      • Clinipace Worldwide, United States
      Shu  Han, PhD, MBA

      Leveraging Natural History Data for Rare Diseases Drug Development: A Bayesian Perspective

      Shu Han, PhD, MBA

      • Head of Biostatistics
      • Moderna Therapeutics, United States
      Cristiana  Mayer, PhD

      A Bayesian Approach in the Non-Inferiority Setting

      Cristiana Mayer, PhD

      • Scientific Director, Statistical Modeling and Methodology, SDS
      • Janssen Research and Development LLC, United States