JSM 2004 - Toronto

Abstract #301656

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Activity Number: 193
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301656
Title: Creating a Pharmacogenomics Data Warehouse
Author(s): Surya Mohanty*+
Companies: Johnson & Johnson Pharmaceutical R&D, LLC
Address: 1125 Trenton-Harborton Rd., Titusville, NJ, 08560,
Keywords: pharmacogenomics ; anonymization ; data warehouse
Abstract:

In clinical trials is has become customary to collect blood samples for the purpose of genotyping. The intent is to associate genotypic or phenotypic measures to clinical measures. The presentation will discuss about what paradigms could be used for collection and analyses of genes know to impact the disease as well as the situations where no such information may be available. In order to generate any hypothesis on the association, large number of patient information would be required. This information will typically span over multitude of trials for the same compound and the same indication. Therefore a systematic method of storing these data is necessary. This presentation will discuss such issues. Other issues will also be considered: (1) Once the data has been stored, what type of tools is required to analyze such data? (2) How do we implement these information in designing future trials? (3) What is the regulatory guidance?

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Revised March 2004