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Grant Abstract

Grant Number: 5R44AT001448-03
Project Title: Geonomic Bioresponse Quality Control for Botanical Drugs

Abstract: DESCRIPTION (provided by applicant): Developing appropriate quality control metrics for botanical drugs represents a major challenge for the acceptance of botanical drugs by the FDA and, consequently, the scientific and medical communities. Recent improvements in analytical chemical methods allow for the acquisition and examination of high resolution, molecular phytochemical fingerprints. There continues to be, however, an indispensable need to develop a sensitive, global bioassay as an orthogonal approach to the chemical characterization. Recent technology advances in comprehensive gene microarrays and transcription profiling provide a powerful approach to developing a genomic bioresponse profile that is ideally suited for monitoring botanical drug quality control. With demonstrated feasibility in the Phase I grant, this proposal will focus on industrialization of this patented platform and have three specific aims: 1. Define a final signature set of genes for PHY906 as well as the four individual ingredient botanicals and develop a robust real-time quantitative PCR plate assay to monitor the bioresponse of these sets of genes 2. Develop pass/fail specifications for quality control through integration of the bioresponse profiles with available chemical fingerprints and animal data 3. Develop standard operating procedures (SOP) and obtain FDA approval for the genomic bioresponse assay as a key element of a comprehensive platform for monitoring the quality control of botanical drugs. We expect that the first nine months of this proposal will focus on refining the gene expression data on our clinical batch of PHY906 and developing a unique signature set of 20-40 genes for monitoring botanical quality control. The next six months will focus on examining multiple manufactured batches of PHY906 to determine specification pass/fail criteria. During the next 9 months we will finalize SOPs and methodologies and work with the FDA to develop this method as a general biological response assay for botanical drugs.

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