A ramp-up in laboratory data generation has brought the pharmaceutical and biotech sectors to a tipping point in information technology (IT). Given the increased complexity of gathering, analyzing, and routing information, research managers say they are ready to hand IT over to experts and turn their undivided attention to core competencies such as drug discovery, development, and clinical trials.
In other industries, this approach was called reengineering, and it happened 10 years ago. In science-intensive businesses, however, IT has been viewed as highly proprietary--it was designed to fit researchers' specific needs. As IT users, researchers are notoriously covetous not only of their research data but also the mechanisms and protocols for sharing data. Software development has, therefore, remained in-house.
Several recent developments, however, indicate that IT reengineering is under way in the lab. Last month, Quintiles Transnational, a leading contract research organization (CRO), announced a partnership with eTrials Worldwide, a software firm specializing in electronic data capture for clinical trial operations. As part of the agreement, Quintiles will license eTrials' eClinical software for clinical trials and will collaborate with eTrials to develop technology geared toward Phase IIIb and postapproval clinical trials. Software based on Quintiles' expertise in late-stage clinical trials will be licensed by eTrials to other customers, says John Cline, chief executive officer of eTrials.
"Our business is not developing software; it is doing clinical studies," says Hugo Stephenson, president of Quintiles Strategic Research Services. "Having the software to drive these studies is critical, but no longer a differentiator." He says the way to stay at the cutting edge in IT now is to pursue partnerships with leaders in the field.
Data analysis is another area in which partnerships are forming to deal with changes spurred by explosive growth in data generation. InforSense, a U.K.-based developer of work-flow analytical software for drug discovery, recently signed a joint system development deal with BioTeam, a Cambridge, Mass.-based developer of scalable computing grids for life sciences applications. Michael Athanas, a partner at BioTeam, says researchers are turning to commercial software to manage costs and also to enable laboratories to keep up with projects that start small but quickly morph into major global research projects.
Rainer Fuchs, vice president of research informatics at Biogen Idec, says the basic issue of storage space is a sufficient impetus to invest in commercial data management systems.
BEYOND STORAGE, there is a need to route data and establish tools to assist researchers in combing through journals and other information sources. Biogen Idec recently signed contracts with InforSense and NuGenesis Technologies, a data management software firm, to address this need. The merger of Biogen and Idec prompted the company to develop an intranet system as a "centralized corporate knowledge repository" using software supplied by Weblogics. Documentum software was added to support collaborative work on the net, according to Fuchs.
Fuchs says, however, that standard approaches to knowledge management are not a good fit for researchers, whom he says are leery of "ill-defined" knowledge management tools. His challenge, he says, is to develop an IT infrastructure that promotes the idea of sharing research, both internally and with external partners, by giving scientists a clear idea of the advantages of doing so. "We are aggressively thinking about both 'carrots' and 'sticks' to encourage scientists to share their knowledge," he says. Fuchs admits, however, that it is much easier to come up with "sticks" than with "carrots."
As new software emerges for analyzing and managing data, however, the business of selling off-the-shelf database software for drug discovery is drying up, according to Alon Amit, vice president for science and technology at Compugen USA. The company is now leveraging its bioinformatics capabilities to form partnerships in which it hopes to access the data needed to develop exclusive intellectual property on novel protein therapeutics that can be marketed for royalties.
Compugen recently announced a joint systems biology research project with Novartis in which the partners will develop a proprietary platform for research and analysis of microarray and other biological data.
"We have the algorithm developers and bioinformatics experts, but we have less of the actual, real-life data that we need to work with," Amit says. "With Novartis, it's the other way around."