Meet the Special Library: Genzyme Corporation, Regulatory Affairs Department Library by Mary Durham, mary.durham@genzyme.com

Introducing Genzyme -- One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees worldwide and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States. With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing.

The regulatory process -- None of this can happen without authorization from regulatory agencies – such as the U.S. Food and Drug Administration – in the countries where the products are distributed. The regulatory process generates large quantities of documentation, and a single document may run to dozens of linear feet of shelf space. Genzyme has a Regulatory Affairs staff numbering 135 in the U.S. alone. An oft-stated statistic is that it requires 10 years and a billion dollars to bring a drug product to market. Over the course of 10 years, and then extending throughout the marketed life of the product, documents are generated regularly. If a patient experiences a suspected adverse reaction to a drug, it is reported through regulatory channels. If a manufacturing process needs to change, approval is sought through regulatory channels. If the marketing department develops a brochure, it may need to be reviewed and approved by a regulatory agency before it can be given out. It is quite eye-opening to learn about these regulatory processes and the implications that they have for library services.

History of our library – The Regulatory Affairs department library really began in 1999 when the Director of Regulatory Operations contracted with a librarian-consultant to set up a system for managing what was largely a paper collection. Many of the practices that were introduced at that time continue in some form today.

Library services in the regulated environment -- The example that we hold as our benchmark involves FDA inspections. FDA can arrive at any time, without prior notice, and ask to see any of the regulatory filings and associated correspondence in a timely manner. So our bottom line is that we need to be able to locate and produce any of the Regulatory Affairs Library’s 34,000+ documents at any time.

This introduces some interesting challenges.

• One is that we need excellent retrievability in our collection. We are fortunate to have a custom-developed software system supporting our requirements. It can conduct a variety of searches as well as producing several reports based on our search parameters.
• Another is that we need to catalog/index in anticipation of those retrieval needs. Since this is all proprietary documentation, original cataloging is the only option available. Our staff of 4 professional librarians, supported by 1 assistant and 1 manager (also a professional librarian) adds 700-1100 documents a month, all with original abstracts and Genzyme-unique metadata tagging.
• A third challenge relates closely to the first. Reference questions often become time-critical because they originate in inquiries from regulatory agencies. In providing research services to our patrons, we always inquire about deadlines early in the reference interview. Beyond that, though, we have moved more and more towards self-serve resources. Patrons can search our catalog and generate reports just as the staff can. Documents are largely electronic and can be retrieved by authorized patrons directly from our document management system. Our catalog includes URLs linking each catalog record to its associated document in order to make this straightforward.

Partnerships and resources -- We are fortunate to partner with Genzyme’s Competitive and Technical Information service, which operates at the corporate level, providing online journal subscriptions, research services and business intelligence. This allows us to focus on the regulatory materials and requirements. We maintain a small collection of journal titles and books that is very focused on the regulatory subject area, and we utilize an online service/repository called IDRAC that allows us to research regulations and supporting material for most areas of the world.

Future trends -- Moving forward, we definitely see trends from the various regulatory agencies in the direction of electronic documents being the copy of record, rather than their paper counterparts. More regulatory filings are being created as software-enabled electronic documents. While our cataloging practices are only minimally impacted by this trend, our management of the documents moves much more in the direction of becoming a digital library/archive.