With the recent launch of its G23 genomic knowledge platform, iBiomatics has made its first move away from the clinical trials data management solutions inherited from parent company SAS.
Spun off from SAS in May 2000, iBiomatics creates Web-based portals for biomedical researchers to store and access data. Its initial products were the SAS-developed PH.DataWare for clinical data warehousing and PH.Clinical for the medical and statistical review of clinical information.
Now the company is ready to tackle the demands of genomic data integration, said Chris Glass, marketing communications manager at iBiomatics. “With all the recent advances in genomics there’s going to be a lot coming down the pipeline and we’re going to be ready to help customers integrate that data so they can use it,” Glass said. “The big challenge is going to be integrating this genomic data into the clinical trial setting.”
G23 takes a middleware approach to data management, integrating data from genomic instrumentation systems and other sources using engines specifically designed to input data structures. Some engines may support instrumentation from multiple vendors, the company said. For example, an engine is in development to support the Genetic Analysis Technology Consortium schema, which would be able to access data stored by vendors who comply with that standard.
Glass said that iBiomatics will first customize engines based on client needs, but intends to build up a library of engines.
Once the data is accessed through the engines, G23 catalogs the data in a standardized format so that it can be accessed through a Web-based interface on the researcher’s desktop.
Glass said that iBiomatics’ foundation in clinical trials management should serve as a selling point for potential G23 customers because the system is compliant with the Food and Drug Administration’s Electronic Records and Electronic Signatures Rule, published as 21 CFR Part 11.
As more and more genomics companies move into discovery, Glass said, the importance of FDA validation will become apparent. “When you enter that kind of [discovery] model, at some point downstream the FDA is going to want to take a look at your data,” Glass said. “If the FDA isn’t talking to you, you might not pay that much attention to validation, but if the FDA starts talking to you, it’ll be the most important thing in your life.”
Noting that this capability is still a “difficult sell” for many early-stage biotech companies, Glass said that those who make their genomic data FDA-compliant will save time and effort down the road.
Another advantage for iBiomatics in this area, according to Glass, is its affiliation with SAS, which he called “the de facto standard for electronic submissions to the FDA.”
“At some point in the process, companies are going to put their data in SAS,” Glass said, “So we can help with that.”
G23 is currently installed at a test site for a potential customer. Concurrent with the G23 launch, iBiomatics is also releasing P21, a similar web-based system to manage clinical trials data.
So far, iBiomatics has signed on DevCo Pharmaceuticals as its first portal customer and is close to finalizing several other deals, Glass said.