GVK Biosciences, the discovery research and development organisation based in Hyderabad, India, has extended its existing licence agreement with the US Food and Drug Administration for the company’s clinical biomarker database, GOBIOM (GV BIO Online Biomarker Database), which the FDA helped to develop.
The licence gives the FDA’s Biomarker Qualification Group access to the GIOBIOM database, which includes information on 12,000 clinically evaluated, exploratory and preclinical biomarkers associated with various therapeutic areas and reported worldwide in clinical or preclinical trials.
According to GVK, the database will be “of enormous use” to US agency in its biomarker qualification process.
The FDA’s Center for Drug Evaluation and Research (CDER) published draft guidance for industry on a Qualification Process for Drug Development Tools, including biomarkers and patient report outcome instruments, last October.
In July 2007, GVK Biosciences announced a material transfer agreement with the FDA’s Genomics Group to share information from the company’s clinical biomarker database.
The group would use the database in its Voluntary Genomics Data Submission programme as well as in internal research, while feedback from the FDA would assist GVK in optimising further the content and capabilities of the database to meet reviewers’ needs, the company said at the time.
Commenting on the extended licence, Sreeni Devidas, GVK’s vice president, sales & marketing, informatics, noted that its collaboration with the FDA had helped GVK Bioscience to develop the safety biomarker content in GOBIOM.