GVK Biosciences, a research services firm based in Hyderabad, India, next week will launch a manually curated database of clinical biomarkers that it has been developing in collaboration with an undisclosed large pharmaceutical firm for two years.
The database will be the first comprehensive resource of its type on the market, but it won’t be alone for long: Prous Science, a business unit of Thomson Scientific, plans to launch its own biomarker database in May as an offshoot of its Integrity bioactive compound database.
GVK’s Clinical Biomarker Db is the product of a massive literature-curation effort involving 66 staffers at GVK, Sreeni Devidas, vice president of business development at GVK, told BioInform. The database includes detailed information on around 1,950 unique biomarkers that the company has deemed “clinically evaluated,” meaning that they have been reported in one or more clinical trials.
“We’re not looking at early exploratory markers, where someone noticed a change in a gel or something and called it a biomarker,” Devidas said.
The markers in the database have been gathered from clinical trials registries, pharmaceutical company websites, scientific meetings, and other sources. GVK’s curators then culled through the scientific literature to capture information on nearly 350 different parameters, including the drugs, targets, and indications associated with each marker, as well as the characteristics of the biomarker, its mechanism of action, experimental details, and the utility of the biomarker — whether it has application for prognosis, diagnosis, disease progression, toxicity, response to therapy, or as a surrogate.
This utility classification, as well as information about the nature of the biomarker — whether it is a biochemical, genomic, imaging, or metabolic marker, are key to the structure of the database, Devidas said. “These two are the most important [classifications] because the ability to retrieve information from the database is going to be largely determined by the nature and the utility of the marker,” he said. “If someone is working on a particular utility, or interested in certain types of markers in a particular disease area, this classification is extremely important.”
As an example, Devidas noted that the BCL2 oncology marker has a range of reported utilities, including prognosis, diagnosis, and response to therapy. The structure of the database “allows you to explore what is it that is making a biomarker behave with a particular utility in each case, and you can then look at all the supporting data to see why it was behaving that way,” he said. “Maybe it’s the clinical population, it could be ethnicity, it could be the drug in use, it could be the experimental methods used — any of those parameters we’re capturing.”
“We’re not looking at early exploratory markers, where someone noticed a change in a gel or something and called it a biomarker.”
GVK has worked closely with its pharmaceutical partner and the US Food and Drug Administration’s genomics group to develop the data model that underlies the database. Last July, the FDA signed an agreement with GVK to use information from the database as part of its Voluntary Genomics Data Submission program, and Devidas said that the agency has provided important feedback on its scope and structure. In addition, he said that the company began sharing initial versions of the resource with other pharmaceutical firms last year in order to solicit further feedback.
Clinical Biomarker Db will launch officially on April 1 and the firm will provide quarterly updates of the data. Devidas said it is currently under “active evaluation at most of the big pharmas,” and that two undisclosed pharmaceutical firms in Japan have already purchased licenses.
Devidas declined to provide details on pricing but said it will be “affordable,” with different pricing structures for pharma, biotech, and academic customers. “We know it’s a very large user base so we have managed to keep the price low,” he said.
Prous Weighs In
Prous, meantime, provided a preview of its upcoming biomarker database at Cambridge Healthtech Institute’s Molecular Medicine Tri-Conference in San Francisco this week.
Unlike GVK’s offering, the company’s database will be web-based and will be updated daily, Jorge Manrique, vice president of sales and marketing at Prous, told BioInform. He said that the product will be based on the company’s Integrity database, a manually curated collection of more than 280,000 bioactive compounds.
Manrique said that the Barcelona, Spain-based company moved into the biomarker arena around two and a half years ago, after the FDA refined its definitions of “valid,” “known,” and “probable” biomarkers as part of its VGDS program, and included biomarker research as a priority in its Critical Path initiative.
At the time, Prous was an independent company and was developing the biomarker database as a side project. “After one year, we had curated 90 biomarkers with very high quality,” he said. “We thought it would take years to get to where we wanted to be.”
However, after Thomson acquired Prous last September, the large firm identified the biomarker database as a priority and provided “capital and manpower” to speed its development, Manrique said, noting that between 100 and 120 curators are working on the database at any one time now. As a result, the company expects the first version of the database to include information on more than 600 markers. That number should double by the end of the year, he said.
Manrique said that the database will be linked with the compound information in Integrity, so that researchers have in-depth information on all the compounds associated with a given biomarker, and vice versa. The database will also be available for customers to integrate with their internal information systems however they like, he said.
Manrique acknowledged that GVK’s product will likely present stiff competition because the cost of production is lower in India than in Europe, which will enable GVK to price its database lower than the Prous product.
However, he said he believes that Prous provides a higher quality of curation and “welcomes comparison” between the products. “If they can keep the quality of their database as high as ours at a reasonable fee, then I’d be concerned,” Manrique said.
He added that the tight integration with the company’s flagship Integrity product is expected to be another advantage in the marketplace.
GVK’s Devidas said he was not familiar enough with the Prous product to comment on its quality, but stressed the depth of curation in the GVK database, the fact that it was developed in partnership with the FDA and a pharmaceutical firm, and the higher number of markers that it currently houses as advantages.