On February 24, 2010, FDA launched its Advancing Regulatory Science Initiative to transform the way medical products are developed, evaluated, and manufactured. This Regulatory Science is defined as "the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products." This science needs to be a team effort, requiring integrated/applied thought and effort from all of the players — the professionals associated with the discovery, development and review of new drugs, biologics and devices. Statisticians need to know and think about this new science, constantly defining and applying rigorous quantitative thinking in making the decisions to discover, move forward and regulate new products. It's bigger than all of us in industry, government and academia, and it needs to be collaborative and strategic. This forum will describe the challenges and opportunities associated with making this happen.