GVK extends biomarker database license with FDA

Indian contract research organization, GVK Biosciences has granted continuous access to USFDA for its biomarker database, GOBIOM

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GVK BIO extends the existing agreement with FDA

GVK Biosciences (GVK BIO) is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its biomarker qualification process.

The GOBIOM database is a comprehensive compilation of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM contains information on 20,000 biomarkers comprising of biochemical, genomic, imaging, metabolite, cellular and physiological markers, along with multiple data points comprising of experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.

Mr Sreeni Devidas, vice president, sales and marketing, informatics said, "The collaboration with the USFDA has helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further."

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Angel 1 March 2013 at 10:22 PM

The roadmap is sure to pcorude plenty of discussion and debate at the conference, which I am looking forward to. In relation to 2), the indications to date are that RE is a very complex disease and may not have just one cause. For example, an unfortunate line up of all of the following could be needed to pcorude the disease: a) a genetic predisposition; b) a virus; c) an aberrant immune response to a viral or other antigen and d)an inherrent weakness/break in part of the blood-brain-barrier. As with cancer, effective therapies might be developed even before we fully understand the cause. For example, if the target antigen could be identified, therapies might be able to be pcoruded that directly address this. But understanding the cause and underlying processes is, of course, the holy grail.

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