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GVKBIO extends license of biomarker database to FDA

By Dan Stanton , 06-Feb-2013
Last updated on 07-Feb-2013 at 08:55 GMT

GVK Bioscience has granted the US FDA further access to its clinical biomarker database following an extension of its license agreement.

The GOBIOM database, developed by Indian contract research organization (CRO) GVKBIO, contains extensive information on biomarkers that are currently being evaluated globally in preclinical studies and clinical trials.

Dr Ramadevi Sanam, Principal Scientist at GVKBIO, told Outsourcing-Pharma.com that tracking drug-induced toxicity information is “Imperative” for the US Food and Drug Administration (FDA), adding that the database “serves as a one-stop repository for all the required information in their biomarker qualification process.”

The two organisations have worked together since 2007 when GVKBIO granted access to the database. An extension of the license was granted in 2011 which allowed the FDA to develop its biomarker qualification programme .

Dr. Sanam said that the extension was valid for a year and though it has “no financial implications,” GVKBIO will receive assistance from the FDA in its biomarker vocabulary and classifications.

Since 2007, the database has grown from 300 to over 20,000 biomarkers along with multiple data points covering experimental, analytical, clinical and statistical information.

GVKBIO has said it is keen to license the database out to other companies and presently has a client list which includes pharma, biotech and diagnostic companies. A number of academic bodies are also using GOBIOM, including researchers at 55 US medical centers and universities in a deal signed in 2011.

The database “will help the user in understanding a biomarker translational process,” said Dr. Sanam. He added that it has “rich information on oncology, cardiovascular, neurological and metabolic disorders” echoing the present necessity and demand in preclinical and clinical development.

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