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Benefit-Risk Assessment of Medicines: Three Perspectives on Current Methodologies and the Statistician’s Role in Implementation
Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
Benefit-risk framing and quantification are increasingly becoming part of a pharmaceutical company’s internal decision-making process and regulatory deliverables. Various approaches are available to companies to deploy these methods. In this session, we will focus on the statistician’s leadership role, as well as success in methodologies used, in the use of benefit-risk quantification for making better quality (and more timely) decisions, and for improving communication of benefit-risk assessments, including submission preparation.
Learning Objective : Describe real-world experiences of biostatisticians from three major pharmaceutical companies in their efforts to quantify benefit-risk of their compounds, for the purpose of bringing this relatively new concept along and into common practice; Explain to other functional areas the crucial nature of the statistician's deliverables and leadership in achieving quantitative benefit-risk.
Speaker(s)
Getting Everyone on the Same Page: Experiences Using the Benefit-Risk Action Team Structured Benefit-Risk Framework to Support Submissions
Sheila Dickinson, MSc
Novartis Pharma AG, Switzerland
Global Benefit-Risk Lead
Choice of Summary Displays and Impact of Collaborative Tools in Benefit-Risk Assessment
Greg Anglin, PhD
Eli Lilly and Company, Canada
Research Advisor, Safety Analytics
Benefit-Risk Quantification and Methodologies Used Across the Drug Development Portfolio: A Large Pharmaceutical Company's Experience
Susan Mayo, MS
FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics