FDA looks to India

HYDERABAD, India—GVK Biosciences (GVK Bio) and the U.S. Food and Drug Administration (FDA) signed a material transfer agreement in August under which GVK Bio is granting access to its Clinical Biomarker Database to the FDA.

Dr. Felix Frueh, associate director for genomics at the Office of Clinical Pharmacology at the Center for Drug Evaluation and Research at the FDA, says the FDA will access the database at no cost under an open-ended agreement, considering it primarily in conjunction with the Voluntary Genomics Data Submission (VGDS) program. "One of the issues that we've been encountering over the last couple of years," he says, "is that there's a vast amount of literature and knowledge out there about these biomarkers, but there isn't really a good way to capture that information and present it so that everything is one place."

GVK Bio, though, is enabling immediate open-ended access to its database, says Frueh, providing "essentially all the relevant information that you want to have in order to understand what the marker is and in what these novel markers can be used for, in the context of their qualifications." Context, Frueh emphasizes, is critical in understanding the markers' possible uses.

Frueh sees potential value for the database under the VGDS and Collaborative Research and Development Agreement programs, and, perhaps in the future, in reviewing investigational new drug applications. "We want to get a feel for where the database is with respect to the level of information that we can access right away, versus the usability or utility of database structure to enter new information," says Frueh. "Again, a database can be useful for accessing the information that's in there or it can be useful to see new information that we capture in there so that we have it for future reference."

Sreeni Devidas, vice president of business development at GVK Bio, sees value in gathering reactions from the FDA, to "look at what are the different applications that we need to develop to make it reviewer friendly." Although the database won't officially launch until October, it has been open to trial users since March. GVK Bio saw demand for the product thanks to sponsorship from an unnamed major pharmaceutical company.

Opening the database for public use during development proved a good marketing strategy, says Devidas. "What happened is all the cooperating pharmas have been looking at it and giving us their feedback. Essentially what happens is as a result we already have four of the pharmas who have agreed in principle to buy it." Devidas says licensing and purchase agreements are available to suit pharmas, biotechs and academics, and cost is "very affordable relative to some of the database pricing that I have seen out there."

The database offers a lot, says Devidas, because it records 1,500 to 2,000 biomarkers reported and evaluated in clinical trials worldwide in various trial registries and company Web sites. It covers between 5,000 and 6,000 unique sources, listing more than 300 data points that are useful both as a reference and to scientists designing their own biomarker experiments. "They can look at what are the assays that people have been using," says Devidas, plus fields including responses to drugs, prognosis, and populations.

Clients can add their own information to the database, and GVK Bio will continue updating existing markers, entering new ones and responding to feedback. Another selling point is that the biomarker database—like GVK Bio's others—is curated by human beings. "We don't use any automated methods in any of our databases," says Devidas. GVK Bio is a CRO that employs around 350 scientists in its informatics division. That impresses Frueh, who imagines the visual picture of hundreds of experts sitting at desks, reading scientific literature and entering information into databases. "It's really amazing," he says.