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Learning from success ... and failure: Pharmaceuticals make the most of knowledge management

—from drug development to delivery

By Kim Ann Zimmermann

Although only a handful of new drugs make it to market each year, pharmaceutical companies must carefully track all of their research and supporting documentation to replicate success and to learn from past projects, even failures. It's not just a matter of gathering the data but analyzing it to spot patterns and trends.

Also, because the drug development process can take 12 to 15 years, few researchers are involved from start to finish so staff turnover can complicate the management of knowledge. And a clinical trial can involve thousands of patients nationwide. Knowledge management systems can automatically recognize unexpected results and route them to appropriate people for analysis. They can help save time and ensure that crucial information is not overlooked.

KM can also help pharmaceutical companies keep track of and meet seemingly endless and sometimes ambiguous federal regulations. Earlier this year, the U.S. Food and Drug Administration announced the first steps in a broad initiative to modernize the agency's regulation of pharmaceutical manufacturing and product quality and the documentation that supports drug research and manufacturing efforts.

The initiative provides for "enforcement discretion" in certain areas while the FDA considers whether to revise the Part 11 regulations to facilitate innovation for modern manufacturing, electronic record keeping and regulatory submissions. Earlier interpretations of those regulations, which have been in place since 1997, had restricted the use of electronic documents for signature validation and audit trails, among other functions.

"There is a lot of uncertainty in terms of regulations specifically related to electronics record management and signatures," says David Keim, national account manager, life sciences, for Hyperwave. "Everyone is standing still, waiting for some definitive action," he says. The FDA is expected to provide further guidance later this year.

Despite or in light of such challenges, pharmaceutical companies are taking a more proactive approach to managing knowledge, observers say.

"It is no longer good enough just to put the information out there," says Martin Sumner-Smith, VP of pharmaceutical and life sciences solutions for Open Text. "Now, the knowledge management system needs to go beyond simply making the information available. There has to be a way to be sure that knowledge is being put to work."

"Drug researchers need to gather information from all kinds of places in an automated fashion," says Michael Rosenberg, associate director of bioinformatics at Biogen, a biotechnology research firm. "We need information from newswires, Web sites as well as peer-reviewed literature, but we don't have time to read it all. Knowledge management has to do two things: intelligently categorize information and make it relevant to the individual user. That's the ideal we're working toward."

Spirig Pharma AG, for example, is pushing knowledge to individuals based on their current projects and interests. It has been an Open Text user for several years. "For two years prior to implementing [Open Text's] Livelink, we used a shared drive to store all important information," says Dr. Christian Pflugshaupt, executive member of the board of management at Spirig. Livelink has automated much of the knowledge management process and tracks individual tasks associated with drug research and development.

"Our know-how is circulated faster and more effectively throughout the organization, clearly a value-added," Dr. Pflugshaupt says. Spirig is considering providing suppliers with access to some of the information in its system, he adds.

The need to share best practices is important in the pharmaceutical industry, where much can be learned from a project even if a drug is not developed as a result of the research.

"There is a huge need to capture knowledge from all of the research that is done, not just from the projects that ultimately result in drug development," says Rock Gnatovich, president and COO of Spotfire.

The need to share information doesn't stop once a drug is developed. Many pharmaceutical companies face the challenge of managing the information that is accessed by their sales representatives in the field. Those sales representatives need to interact with physicians and provide accurate information about the drugs. The Malaysia-Singapore division of Pfizer Pfizer is testing Sopheon's Accolade knowledge management system to store all of its product data and make it accessible to the sales force in the field.

"Accolade acts as a centralized, easily accessible repository that enables us to supply our customers with timely and accurate information on our products," says Malini Tharumalingam, business technology director of Pfizer Malaysia-Singapore. "The system has added substantial value to our business."

Pfizer also recently licensed business intelligence software from Business Objects to analyze such information as revenue, costs, performance and customers; up-to-date finance reports that examine such items as the amount of money spent on business travel, automatically distributed through the finance department; procurement reports that track the timeliness of purchase orders and deliveries; and research and development reports on scientific research.

"Knowledge management isn't limited to the drug development process," says Chris Hawver, chief marketing officer of Sopheon. "This really enables the pharmaceutical salesperson to have an interactive and meaningful conversation with the physician. Plus, the sales staff can review and share comments from physicians."

Kim Ann Zimmermann is a free-lance writer, 732-636-3612, e-mail kimzimmermann@comcast.net

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