GVK Biosciences to provide clinical biomarker database USFDA Genomics group

Pharmaceutical contract research organisations, GVK Biosciences (GVK BIO), has signed a material transfer agreement with the Genomics group of the US Food and Drug Administration (USFDA) to share information from its clinical biomarker database.

The Genomics group at the FDA will use the database in its VGDS (voluntary genomics data submission programme) as well as in its internal research. GVK BIO will use the feedback from the FDA to further optimize the content and capabilities of the database to meet reviewers'' needs.

Currently, the GVK BIO database contains over 278 different fields for clinically reported biomarkers captured from the published literature. Data ranging from clinical to the pre-clinical stage has been captured and would be used for design, validation and as a knowledgebase of studies where biomarkers were reported.

"It is the first of a kind collaboration in the Informatics field for a company based out of India," said G V Sanjay Reddy, chief executive officer, GVK BIO. "We are happy to be working with the USFDA on the biomarker database."

Sreeni Devidas, vice president, business development, commented: "The agreement with the FDA further validates the positioning of GVK BIO as a leader in the life-sciences database industry. The product will be very useful to researchers, in the emerging area of Biomarker research, in the Pharmaceutical and Biotech Industry as well as academia".

GVK BIO''s informatics division is responsible for analysing data to transform chemical / biological patterns into knowledge. Its informatics offers custom curation, cheminformatics and bioinformatics services to global clients and licenses and sells databases to biotech and pharma companies.

GVK Biosciences provides an integrated platform of research services across the Pharma R&D value chain to a growing number of global pharma and biotech companies to help them address their drug discovery and development programmes.