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Activity Number: 174 - Biomarkers and Endpoint Validation
Type: Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #329078 Presentation
Title: An Analysis of MIMIC Data for Potential Surrogate Markers for Vaccine Development
Author(s): Robert Small and Pauline Jurvilliers*
Companies: Sanofi Pasteur and Sanofi Pasteur
Keywords: Surrogate markers; Information Theory

The development of vaccines has become difficult and expensive and therefor in need of earlier tests of efficacy in development. The analyses developed by Molenberghs and colleagues provide models for assessing surrogate markers that may be useful in predicting success at an early stage. In this paper we provide an analysis of data from a MIMIC experiment to demonstrate the use in the development of vaccines. The MIMICĀ® (Modular IMmune In vitro Construct) System is a surrogate human immune system that enables researchers to test the immune response to a vaccine directly in a human system. By testing the human immune response outside of the sample donor it allows the testing of multiple antigens in the same person. This often reduces the variability of the differences substantially and therefore allows the assessment of candidate surrogate biomarkers with modest samples sizes. Slight adjustments to the usual techniques allow the information theoretic methods to give useful results. A demonstration of the techniques on seven flu experiments is given.

Authors who are presenting talks have a * after their name.

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