WILLIAM D SHANNON CONSULTING LLC — Department of Health and Human Services SBIR Phase I: 300

Description

DESCRIPTION provided by applicant Design of experiments and test of hypotheses need to be available to research teams to develop and validate taxonomic metagenomic biomarkers in gastrointestinal tract GIT diseases The translational research team needs to design an experiment to test a hypothesis e g microbiota in Crohnandapos s disease is different than in normal controls calculate the number of subjects needed to ensure a set level for power and significance for testing differences in taxa frequencies at a defined level e g class genus have an objective test statistic to decide if the null hypothesis is rejected possibly adjusting fr patient factors such as age gender diet etc and possess tools to calculate diagnostic performance needed to validate biomarkers e g sensitivity specificity positive negative predictive probabilities Current analytic approaches e g mass univariate andquot one taxa at a timeandquot comparisons with multiple testing adjustments exploratory cluster analysis are excellent for discovery but the subjectivity in their application and interpretation e g Bray Curtis versus Jaccard distance make them inappropriate for translational research Objective decision making using parametric statistical tools is necessary to move metagenomics from the discovery phase to clinical biomarker validation and qualification This Phase I SBIR will develop and commercialize an experimental design and statistical analysis software platform for translational clinical research teams developing diagnostic and prognostic taxonomic labeled metagenomic biomarkers for gastrointestinal tract GIT diseases Existing open source software and new software will be organized into the STATISTICAL TOOLS FOR GIT TRANSLATIONAL RESEARCH platform An open source business model similar to Red Hatandapos s Linux and Clouderaandapos s Hadoop will be used with revenue generated by offering optionally a licensed proprietary GUI to facilitate deployment and use of these functions contract for Data Analysis As A Service DAAAS model cloud computing and consulting services It is important to note that the platform will not replace the metagenomic pre processing pipelines e g data acquisition assembly annotation RDP matching but takes the end product of these steps e g taxa by sample frequency tables to analyze for clinical use PUBLIC HEALTH RELEVANCE Metagenomics is being seen as the next revolution in gastrointestinal research and health care This project will develop new statistical tools for analyzing metagenomic data in biomedical research to measure how differences in bacteria populations can be used to predict gastrointestinal disease progression and identify the best treatment options for patients With these tools researchers will be better able to use these big data resources to improve human health