USFDA Extends the License of the GVK BIO Biomarker Database
February 04, 2013
Hyderabad, India — GVK Biosciences (GVK BIO) today announced that it 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.
Sreeni Devidas, Vice President, Sales & 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.”
About GVK BIO
GVK Biosciences (GVK BIO) is Asia’s leading drug discovery, research and development organization providing a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Our discovery services consist of Chemistry, Biology and Informatics; the development services include Clinical Research, Clinical Pharmacology and Process R&D. GVK BIO’s diverse portfolio and global clientele comprising more than 200 customers includes some of the global leading organizations in the fields of pharmaceuticals, biotechnology, agro, life-sciences as well as prestigious academic institutions.