Drug Makers Enter a New Era of Sharing

Drug companies next month will start using a secure Internet-like system to share research data with one another and file regulatory forms with the Food and Drug Administration. CRIX International, the non-profit group that developed the system, says a new era for drug makers is about to begin.

Jim Bland, executive director of CRIX, says drug makers and the FDA have been “interested in this for years, but it was never successfully pulled off. It’s groundbreaking.” Bland says the system includes 15 to 20 companies ranging from roughly $20 million in revenue to giants like Merck & Co. Inc. in Whitehouse Station and Pfizer Inc. in New York City.

The FDA has called such a system “a big step toward the fulfillment of [President Bush’s] national health information technology effort, one goal of which is to make medical products safer and more effective.” In compiling research on how such a common electronic platform would work, the FDA sought input from small businesses to help the agency determine how they could contribute to the system.

Bland says there is opportunity for IT companies to provide products and services that CRIX members may need. “We see this as opening a potential marketplace,” he says.

Cutting down on the paperwork and time associated with paper filings will save drug companies millions of dollars a year, says Bland. He says it costs drug makers as much as $1,500 to file a single regulatory form, with big companies pumping out as many as 3,000 forms per year. CRIX, which stands for Clinical Research Information Exchange, will charge a few hundred dollars per form to cover the costs of building and maintaining the platform, he adds.

At first, the system will be used to collect and store information about clinical investigators, who are hired by drug makers, universities and other groups to run studies of experimental therapies in humans. If the FDA gives the go ahead, drug companies will then be able to file clinical trial forms electronically. Later, the platform will be used for such things as matching people with clinical trials through the Internet, Bland says.

CRIX was born of a National Cancer Institute effort to bring drugs to market faster and more efficiently through information technology that companies, government agencies and universities could use to share clinical research data.

Based in Reston, Va., CRIX was founded in 2006 with $2 million apiece from Pfizer and Amgen Inc. in California, plus a smaller amount from Switzerland’s Novartis, whose U.S. headquarters are in East Hanover. Merck has been developing software for the project.

CRIX is currently working with Pfizer to make it easier for patients and doctors to report bad drug reactions, says Michael Ibara, head of pharmaco-vigilance information management at Pfizer, which has some 2,000 employees in New Jersey.

While anyone can report an adverse reaction to a drug company or the FDA, Ibara says the form is hard to find on the agency’s Web site and time-consuming to download and complete. “The burden of reporting is great.” Partly as a result, anywhere from 50 to 90 percent of adverse drug events go unreported, he says.

The CRIX-Pfizer project will enable doctors to report adverse drug events through the patients’ electronic medical records, which Ibara says will make reporting faster, easier and more common. The project will launch in September at Boston’s Brigham and Women''''s Hospital, which is affiliated with Harvard Medical School.

The project’s main purpose is to improve patient safety, says Ibara. “It’s a sign of how pharmaceutical companies are starting to work together more.”

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