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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.
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