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Hot Topics in Statistics: Working Together Effectively to Transform Our Science
Session Chair(s)
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
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.
Learning Objective : Discuss key developments associated with the regulatory science initiatives and how they relate to statistics; Recognize the impact of the new guidance, collaborative efforts and the role of statistics in the quantitative thinking needed to transform how medical products are developed, evaluated and manufactured; Identify opportunities for FDA, industry and academia to collaborate in developing methodologies for the quantitative decision-making needed for medical product development.
Speaker(s)
FDA Perspective
Robert T. O'Neill, PhD
FDA, United States
Senior Statistical Advisor, Office of Translational Sciences, CDER
Advisory Committee Perspective
Ralph B. D'Agostino, PhD, MA
Boston University, United States
Chair, Mathematics and Statistics Department
Academic Perspective
Marcia Testa, MPH
Harvard School of Public Health, United States
Senior Lecturer
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