Hot Topics in Statistics: Working Together Effectively to Transform Our Science

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 24, 11:00AM - 12:30PM

Session Number:
119

Room Number:
254AB

Level:
Intermediate

Type:
Forum

Title:
Hot Topics in Statistics: Working Together Effectively to Transform Our Science

Chair(s):
Stephen E. Wilson, DrPH
Director, Division of Biometrics III, Office of Translational Science, CDER
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
FDA Perspective
Robert T. O'Neill, PhD
Senior Statistical Advisor, Office of Translational Sciences, CDER
FDA, United States

Advisory Committee Perspective
Ralph B. D'Agostino, PhD,MA
Chair, Mathematics and Statistics Department
Boston University, United States

Academic Perspective
Marcia A Testa, MPH
Senior Lecturer
Harvard School Public Health, United States