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Strategic Quantitative Thinking: Designing a Roadmap for Innovation

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
141

Room Number:
8

Level:
Basic

Type:
Session

Title:
Strategic Quantitative Thinking: Designing a Roadmap for Innovation

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

Description:
Making effective regulatory decisions through the use of strategic quantitative thinking - PDUFA V, PROs, benefit-risk, rare diseases, safety, missing data, subgroup analysis, multiregional trials, meta-analysis, Big Data, antibacterial trial design and analysis, sensitivity analysis, data quality, improving trials, data standards, SMART Trials, enrichment designs, Bayesian designs, strategic planning, precompetitive collaborations, leadership, communication. This will be a far-ranging, open-microphone Q&A session that will examine priorities, prospects and next steps -- an opportunity to think about innovative systems and approaches to the design and analysis of the quantitative evidence that we need to make decisions regarding the safety and effectiveness of medical products.

Learning Objective(s):
Contrast and critique some of the potential statistical approaches needed to address difficult evidentiary issues associated with the development and review of new medical products; Discuss the current thinking of industry and regulatory professionals in regards to strategic next steps to improve regulatory statistics; Describe an open, transparent framework for the collaborative development of innovative approaches to decision-making in a regulatory environment.

Presentation(s) & Speaker(s):
Panelist
H. M. James Hung, PhD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
FDA, United States

Panelist
Rima Izem, PhD
Lead Mathematical Statistician, Office of Translational Science, CDER
FDA, United States

Panelist
Lisa M. LaVange, PhD
Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States

Panelist
Karen Lynn Price, PhD, MA
Research Advisor
Eli Lilly and Company, United States

Panelist
Ram Tiwari, PhD
Associate Director, Office of Biostatistics, OTS, CDER
FDA, United States

Panelist
Lilly Yue, PhD
Deputy Director, Division of Biostatistics, CDRH/FDA
FDA, United States