What do we need to do and think about in order to "push the statistical envelope"? The most pressing issues facing statisticians involved in the development of new drugs and biologics today will be discussed from a variety of viewpoints. Following a brief introduction from a regulatory perspective, speakers representing the statistical leadership of a large pharmaceutical company, a mid-sized biotechnology company, and a global contract research organization will discuss what they perceive to be critical issues in statistical methodology and/or application. The impact of these hot topics on drug development and regulatory decision-making, both locally and globally, as well as ideas for addressing each issue will be discussed. An academic perspective, particularly with respect to ways forward in developing real-world solutions, will also be provided.

Learning Objectives:
Describe the statistical perspective on the most important issues currently influencing drug/biologic development
Recognize statistical methodology and application concerns relevant to regulatory decision-making
Relate academic perspectives regarding the development of real-world solutions.