Small biotech research company and toolmaker Dyax is using business technology to turn itself into a drugmaker
Hereditary angioedema is characterized by acute attacks of swelling and inflammation and can strike with little warning. Biotechnology and pharmaceutical companies have worked for years to develop treatments for this rare but life-threatening genetic disorder, but not a single drug has passed the Food and Drug Administration's rigorous registration process that would allow it to be sold in the United States. Treatments are available in other countries, but it's illegal to market or sell them in the United States because the FDA hasn't approved their use. It can be expensive for patients to obtain the foreign-made drugs, and they have little recourse if drugs prove harmful.
Changing this situation won't take a miracle, but it will take several years of research and development, as well as several rounds of clinical trials on humans, with the hope of transforming promising drugs into FDA-approved treatments.
Dyax Corp., a small, 9-year-old company in Cambridge, Mass., that sells research on drug compounds and licenses biotech research tools to drugmakers, may have found a treatment to control the swelling caused by hereditary angioedema, as well as blood loss during coronary artery bypass surgery. Dyax has identified a molecule, known as DX-88, that it believes can lead to treatments for both conditions.
But getting DX-88 through clinical trials and past FDA approval is just one part of Dyax's challenges. The company also is trying to transition from being a behind-the-scenes player to a pharmaceutical developer and manufacturer, a leap that biotech leaders Amgen, Genentech, Genzyme, Novartis, and Millennium Pharmaceuticals all have made. Dyax is attempting to continue the transformation trend that's driven the industry forward, and, in Dyax's case, business technology is playing a lead role.
Though Dyax will outsource drug manufacturing, it will still track the process, and it wanted to do so with the same package that ran its accounting system, VP and CFO Galliker says
Photo by Jason Grow
The company's vision has always been to eventually develop medications to fight the diseases and disorders that its scientists study, says executive VP and CFO Steve Galliker. "One of the best ways to get into the business of making drugs is to start with a technology that helps scientists find successful drug leads."
Companies that supply the underlying drug research and technology often want the money and fame that come with developing and marketing successful medications, says Roddy Martin, VP of life-sciences industry research at AMR Research.
But small research companies, like Dyax, which are staffed primarily by scientists, aren't inherently built to operate as large commercial companies. "Now, they have to deal with regulatory-compliance issues, manufacturing-production throughput, and building repeatable and scalable processes," Martin says. These small companies operate on very tight budgets and don't generally require large enterprise-resource-planning systems. "But the complexities of running a business producing marketable medicines kick IT needs into a completely different gear," he says.
Dyax's first IT job in its business-strategy transition was an ERP overhaul to ensure it would be able to handle all the necessary business functions, as well as track multiple testing programs, meet FDA compliance requirements, and eventually oversee manufacturing. It needed applications that would provide an integrated view of its data and allow for modular growth to keep up-front costs down, Martin says.
In November, Dyax implemented Ross Systems Inc.'s iRenaissance ERP system. One of the primary benefits of iRenaissance is that Dyax bought its general-ledger and financial-reporting components last year and will be able to add the manufacturing and inventory-tracking modules when its first drug is ready for the market, Galliker says.
IRenaissance replaces Great Plains software that Dyax put in place four years ago. The company is counting on iRenaissance to simplify the integration and consolidation of its global financial operations, improve purchasing, and monitor project costs for drug trials and other programs.
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