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Strategic Quantitative Thinking: Designing a Roadmap for Innovation
Session Chair(s)
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
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 : 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.
Speaker(s)
H. M. James Hung, PHD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA, United States
Panelist
Rima Izem, PHD
Associate Director Statistical Methodology, Novartis, Switzerland
Panelist
Lisa LaVange, PHD
Professor Emerita, University of North Carolina at Chapel Hill, United States
Panelist
Karen Lynn Price, PHD
Senior Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company, United States
Panelist
Ram Tiwari, PHD, MS
Head of Statistical Methodology, Bristol Myres Squibb , United States
Panelist
Lilly Yue, PHD
Deputy Director, Division of Biostatistics, CDRH/FDA, U.S. FDA, United States
Panelist
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