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Life science KM leaders discuss data search, reuse

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Knowledge management is a relatively new discipline in the life sciences industry. Even large companies may not have a well-defined KM structure or team. When KM leaders from pharmaceutical giants, midsize companies and startups gathered at an event in August, a common theme was the duel challenge of making search of internal documents more efficient and getting researchers to see enough value in sharing information that they will change business practices.

In brainstorming and sharing lessons learned at ExL Events’ Life Science Knowledge Management Summit, many attendees said their colleagues have difficulty finding the information they need to do their jobs, and that organizational and IT structures are often barriers.

Keith Davis, global director and head of knowledge, records and information strategies at Biogen Idec, led off the meeting by noting that KM might mean different things to different people, and includes business intelligence, data architecture and analytics. “My background was around records management, and I never thought of them as building blocks until a few years ago,” he admitted. Now Davis sees them as an enabler. “It is a glorious marriage between information and collaboration, allowing employees to find content and expertise in a timely manner,” he said.”

Davis introduced a series of speakers who talked candidly about their efforts to solve specific problems of knowledge creation and management in their organization,

Structured content management system

Michael Jasper, an executive of Genzyme, a Sanofi company, talked about the development of a structured content management system to accelerate document development and standardized content.

Jasper, who is director and program manager of clinical documentation for the CRUISE Content Re-Use Program, noted that one way to structure content is through the use of templates, but one problem is you may run into document templates owned by different groups that define content differently. They have the same name but different ideas about what is in there, he said.

“Another way is to standardize content,” Jasper added. His organization is working to create and identify standard chunks of content that can be used consistently in related documents to facilitate automated transfer. The information can be managed and repurposed across publications and departments. An example would be inclusion and exclusion criteria for a clinical study. That information should be unchanged across all the documents related to the study. Or the rationale for a study can be reused among synopsis, protocol and clinical study report (CSR), and would not change.

Sanofi has been working since 2010 to develop an information architecture that involves analyzing and decomposing documents, and breaking them down into topics to decide on reuse rules. It involves changing from a document-centric to a topic-centric way of thinking.

A potential benefit is to save time spent finding and reviewing information. “You can lock down approved sections, so that people are not spending time reviewing things they can’t change anyway,” Jasper said. There are huge benefits in consistency in terms of how you structure things. You could have the same criterion written eight different ways in eight different protocols. This has the potential to get the right information in the right place and reduce churn and parallel documents.

Another goal is to have a tool that links stated objectives and end points, which can force a structured kind of thinking. “We want to be able to say something based on the study,” Jasper said. This can flag an objective that has no end point. That in turn can reduce the number of incomplete designs that lead to amendments.

He noted that the idea of working in topics instead of documents is a big change for everybody involved. Getting writers thinking about topics in segments that can be reused is challenging. Some employees were concerned about loss of control and creativity. “That took me by surprise,” Jasper said. “Writing exclusion criteria didn’t strike me as creative. I think the design of the study is where the creativity comes in.”

Playing the connector role

Gigi Shafai, associate director of medical information management in medical scientific affairs at Ironwood Pharmaceuticals, talked about the challenges of bridging different parts of a life sciences company. She noted that communications between medical affairs, sales, marketing and clinical information can be challenging because of different goals and organizational culture in each department, and the complexity level goes up with the size of the company.

Information can more easily become siloed in larger corporations, she said. Her company has grown from a startup to a midsize company in a short period of time, which has led to knowledge sharing challenges.

Having worked in different departments in life sciences companies, Shafai has found that the core connectors tend to be in medical affairs. “They bridge the outside world to the inside of the company and different parts of operations,” she said, offering several ideas for ways those teams can play that connector role. One is decentralized seating—having medical affairs staffers spend one day a week sitting in other departments listening to what R&D or discovery are talking about.

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