HOPKINTON, Mass.—A joint development project between VelQuest Corp. and Symyx Technologies Inc., is creating a new pharmaceutical industry alphabet soup by joining R&D and GMP in a comprehensive ELN (electronic lab notebook) software platform.
The impetus for the project came in the form of a challenge from a large pharmaceutical company that cannot be named, says John Helfrich, director, GMP automation programs, at VelQuest. The client uses both companies' specialized products: VelQuest's SmartLab GMP ELN for manufacturing quality control and assurance, plus Symyx's ELN for research and development. "We're only applied to GMP laboratories," says Helfrich. "That's it. That's our sole purpose in life. That's a unique position."
Although R&D software is designed to help scientists succeed in open environments where researchers can dump data into an ELN, "the second you get into manufacturing in GMP, you want just the opposite," says Helfrich. "You want it very rigid, you want it very systematic." The companies aim to find what Helfrich calls a seamless handoff for the middle ground between the two existing ELNs, so the integrated systems segue from late-stage drug development directly into quality control, where compliance is crucial and VelQuest has developed instrument interfaces.
Although the collaboration was announced in mid-May, work began early this year and has progressed enough that the companies are working out the mechanics of the handoff. Symyx and VelQuest expect their 18-month project to provide their client with a product during summer 2008. They will then offer the joint product to the public as a configurable off-the-shelf system.
Target markets include big pharma as well as generics companies and suppliers of active pharmaceutical ingredients. VelQuest and Symyx plan to bring Web briefings of the integrated platform online in late summer 2007. Both companies cite average personal productivity gains of 20 percent among users of their ELNs, and the new platform is expected to reduce paper-based intellectual property and compliance documentation processes for drug development and production.
Teresa Thuruthiyil, vice president, investor and public relations at Symyx, believes the VelQuest-Symyx program creates numerous financial and operational efficiencies for clients. "The integration of our products yields a powerful solution and helps reduce the cost of implementation and overall total cost of ownership, she notes in a written statement describing the deal. "Major pharmaceutical companies all face increasing development and production costs. This is one way to make the process both more efficient and potentially more fruitful because scientists can spend more time on science and less time on integration and documentation issues."
Integrating such disparate types of data was formerly such a technical headache that many drug industry IT departments thought R&D and quality control data would never meet. Helfrich says new capabilities for data handling and extraction enable fulfilling the data and business needs of both groups in the VelQuest-Symyx product. The biggest driver of the effort to join R&D and GMP data is reducing costs in a leaner environment, says Helfrich, while bringing good, quality medicines to market faster.