INTERORGANIZATION AND COLLABORATION

THE INTERNET AND THE INTRANET SHORTEN TIME-TO-MARKET FOR NEW DRUGS

The Federal Drug Administration (FDA) must be extremely careful in approving new drugs. However, there is public pressure on the FDA to approve new drugs quickly, especially those for cancer and HIV. The problem is that to ensure quality, the FDA requires companies to conduct extensive research and clinical testing. The development programs such research and testing cover 300,000 to 500,000 pages of documentation for each new drug. The subsequent results and analyses are reported on 100,000 to 200,000 additional pages. These pages then are reviewed by the FDA prior to approval of a new drug. Manual processing of this information significantly slows the work of the FDA, so that the total approval process takes 6 to 10 years.

A Software program called Computer-Aided Drug Application Systems (Research Data Corporation, New Jersey) offers a computerized solution. The software uses a computerized solution. The software uses a network-distributed document-processing system that enables the pharmaceutical company to scan all related documents into a database. The documents are indexed, and full-text search and retrieval software is attached to the system. Using keywords, corporate employees can search the database via their company's intranet. The database is also accessible, via the Internet, to FDA employees, who no longer have to spend hours looking for specific piece of data. Information can be processed or printed at the user's desktop computer. Today, the U.S. government is able to offer an electronic submission and online review process for approval of new drugs (fas.gov/cder).
This system not only helps the FDA, but also the companies' researchers who now have every piece of required information at their fingertips. Remote corporate and business partners can also access the system. The overall result: The time-to-market of a new drug is reduced by up to a year. (Each week saved can be translated into the saving of many lives and can also yield up to $1 million profit.) The system also reduces the time it takes to patent a new drug.

An interesting use of this technology is the case of ISIS Pharmaceuticals, Inc. (isip.com), which developed an extranet-based system similiar to the one described here. The company uses CD-ROMs to submit reports to the FDA and opens its intranet to FDA personnel. This step alone could save 6 to 12 months from the average 15-month review time. Simply by submitting an FDA report electronically, the company can save 1 month of review time. To cut even more time, SmithKline Beecham Corporation is using electronic publishing and hypertext links to enable FDA reviewers to quickly navigate its submissions.