Jessica LeFur
Director, Document Management and Planning
OSI Pharmaceuticals
Boulder, Colo.
www.osip.com
Manager’s Profile: LeFur started with Andersen Consulting in 1992, overseeing design and development of an application for maintaining clinical and regulatory data for the pharmaceutical industry. She then joined Johnson & Johnson, and moved to Bristol-Myers Squibb before landing at OSI Pharmaceuticals in June 2001.
What She Does: Maintains OSI’s systems to store, manage and track documents related to regulatory submissions for new drugs.
Why It’s a Daunting Task: The average submission for a new drug in the U.S. contains about 300 volumes, with each volume containing around 350 pages. In other words, about 105,000 pages per submission. In the race to bring new drugs to market, being able to accurately compile and file submissions is crucial. “If you don’t have a document-management system and you’re a pharmaceutical company, you’re going to be beaten every time,” says LeFur.
Her Tool: Documentum’s content management software. LeFur has used it for about eight years; OSI has had the application since July.
Latest Project: LeFur is implementing a capability to allow researchers to view all related documents, make edits, and maintain proper auditing procedures via the company’s intranet. The new features will improve researchers’ abilities to work from three international sites.
Greatest Benefit: Researchers will have a better sense of what is available, what is outstanding and what is the current version. “The tracking of authors and verification that we have the latest and greatest version of a document alone is a project manager’s nightmare,” she says.
Biggest Challenge: Understanding your user community is key to a successful implementation. In one instance, LeFur rolled out an easy-to-use Word template to allow users to write and store documents. However, she later discovered some people didn’t know how to use Word.
Lessons Learned: Make sure you have user and management buy-in, but back it up with adequate funding and resources. If any one of those elements is missing, it can derail a project.
What She’d Like To See: One of LeFur’s complaints was the lack of a pharmaceutical user group within the Documentum community. However, the company has just addressed that issue at its conference in September, with the announcement of the start of a life-sciences users group.
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