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Amersham Adds New Integration Layer, CFR-11 Compliance to Scierra LWS Foundation

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Amersham Biosciences is extending the range of its informatics product line without straying too far from its core LIMS offering by embracing two concepts dear to the hearts of informatics managers: data integration and FDA compliance.

In July, Amersham entered a partnership with Menlo Park, Calif.-based GeneticXchange to combine the company’s discoveryHub integration platform with its line of Scierra Laboratory Workflow System (LWS) tools. The partnership, according to John Schneider, Amersham’s vice president of informatics marketing, “provides the capability for our customers to do bioinformatics not just with the data that we help them collect in the laboratory, but with data that might be in public domain data sources or other proprietary sources.” The combined offering will be available in the current quarter.

More recently, Amersham opted to undergo an independent audit to ensure that Scierra LWS — and the development process at co-developer Cimarron Software in Salt Lake City — is compliant with the US FDA’s CFR Part 11 regulation for electronic records submitted as part of drug applications. While noting that “early research data isn’t necessarily required to be under that level of control,” Schneider said that the likelihood of gene expression and other early-stage genomic data eventually finding its way into clinical settings spurred customer demand for a fully compliant LIMS platform. “A lot of our customers realize that while they’re not strictly required to have this compliance, that it’s possible that data they collect might have significant downstream utility,” he said. “For the added expense of using a system that’s compliant — which isn’t that great, by the way — they get this insurance policy…that if you want to use this data downstream, it’s already qualified.”

The recent moves are part of Amersham’s longer-term strategy to extend the reach of its core informatics offerings, Schneider said. The company eventually expects to see its LIMS — and the underlying sequencing, genotyping, gene expression, and proteomics instrumentation that they support — used further downstream in the drug discovery and development process. “These LIMS systems that we’re building don’t sit forever in the laboratory. They do eventually get used in clinical settings,” he said. In the meantime, Amersham is concentrating on building an integrated data acquisition and management infrastructure “that supports bioinformatics long-term for our customers.”

Part of this strategy involves an expanded professional services capability to help customize its solutions for particular research settings. As one example, Schneider said, Amersham recently agreed to expand a LIMS deal with an academic customer that began in 2001 to integrate clinical sample collection with the four LIMS systems the customer already uses. Amersham’s informatics group currently employs around 100 people, Schneider said, and the company has the ability to move people into professional services “as needed.”

Through additional partnerships like that with GeneticXchange, Amersham intends to wield the influence of its “reasonably good market presence” to evolve an industry-standard informatics infrastructure. Bringing the Scierra LWS together with discoveryHub addresses “a number of early-stage technical problems that have to be solved before a bioinformatics industry… can thrive,” Schneider said, noting that more work remains to be done. “The next important problem that really needs to be solved is to get this infrastructure, this set of common components and standards, established, and to find common ground between the companies that are in the bioinformatics market so that we aren’t all reinventing wheels and we are actually advancing the science of bioinformatics.”

Schneider said that informatics remains a strategic priority within Amersham. As evidence, Schneider said, the group has been “largely unaffected” by the massive reorganization within the company’s Discovery Systems unit that involves a planned headcount reduction of 445 people. “Informatics is one of the key technologies that’s going to help the company move forward on its stated goal of delivering on molecular medicine,” said Schneider. “While today we don’t have all of the capabilities we need, developing a core competence so we can be where we need to be in five or 10 years’ time is very important to the company.”

Shorter-term, Schneider said that new versions of the Scierra LWS systems for microarrays and proteomics “are nearing release now.”

— BT

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