Rx for success

Members of FDA's e-submission team'from back to front: Joe Montgomery, Timothy Mahoney, Michael Fauntleroy and Gary Gensinger'say the project has forged a common bond among the agency's centers.

Rick Steele

'The gateway will provide scalability, the ability to accept the hundreds of thousands of submissions we get.'

' FDA's Timothy Mahoney

Rick Steele

A healthy dose of EA guides FDA's document systems consolidation

The reading room at the Center for Drug Evaluation and Research's facility in Silver Spring, Md., can store 62,000 linear feet of paper. That's a lot of paper, and it's only one of several repositories that collect data for the Food and Drug Administration's centers.

But FDA is using its enterprise architecture to consolidate systems and improve its capability to receive, handle and store submissions electronically under a $4 million initiative.

'In this government environment, where we're asked to do more with less, where we all have budgetary restrictions and ever-increasing responsibilities, EA is our only way to make do with what we have and accomplish our goals,' said Michael Fauntleroy, director for the Electronic Submission Program at FDA's Center for Biologics Evaluation and Research.

In the past, FDA's centers rarely worked together, but its EA has made them partners on the e-submissions project.

The centers that oversee bringing new drugs and other medical treatments to market found that the enterprise architecture made the case more obvious for consolidating business systems around the agency's e-submissions effort.

That, in turn, accelerated the pro-cess by which FDA officials got individual divisions to share systems.

Although FDA had begun plans to consolidate some systems before crafting its enterprise architecture, the blueprint illustrated more commonalties among initiatives than originally thought.

'EA is creating a target architecture for submissions, and this will help us move toward a fully electronic submission process at FDA,' said Gary Washington, the administration's chief enterprise architect.

As part of the modernized process, FDA centers will share a single system for submissions and an electronic-document room. FDA will also consolidate its ser- vers and storage area network.

The full e-submission process will launch later this year with FDA Gateway, the single point of access for pharmaceutical companies and others submitting materials for new drugs and other treatments.

FDA expects to implement the first phase by June and complete rollout by early next year, said Joe Montgomery, technical lead for e-submissions for FDA's Center for Biologics Evaluation and Research.

Previously, each FDA center had its own systems and processes to receive and review materials. Companies dealing with FDA had to communicate with each individual center, meaning vendors and the agency spent money and time on duplicative efforts.
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FDA will use its architecture to integrate systems and consolidate operations, but the blueprint also helps officials understand how technology supports business processes, said Timothy Mahoney, director of the Division of Application Development and Services in the Office of IT at the Center for Drug Evaluation and Research.

Pharmaceutical companies applying for a new drug approval submit voluminous reports. Although they may currently use e-mail to send information, they must still send paper versions to the individual centers. During the lengthy review process, hundreds of cases of paper are submitted for a single drug.

FDA can accept some data electronically, but this simply means it receives CDs, tapes and diskettes instead of paper, Mahoney said. And the administration's centers still work independently of one another.

'With the gateway, within a matter of minutes we'll be able to take this information through the wires, load it into the system and make it available to reviewers. Also, we can have a consistent process, regardless of which center might be receiving the work,' said Gary Gensinger, director of the review technology staff at the Center for Drug Evaluation and Research.

FDA Gateway will generate time savings by increasing the availability of material to reviewers rather than by reducing the length of any reviews, he said.

'The gateway will provide scalability, the ability to accept the hundreds of thousands of submissions we get,' Mahoney said.

A major technical detail is assuring that FDA Gateway can handle large submissions, Fauntleroy said, noting that a license application might equate to 100G of data.

This month, the agency awarded a $2 million contract to GlobalNet Services Inc. of Rockville, Md., to help build the system.

FDA Gateway will use a suite of e-commerce products from Cyclone Commerce Inc. of Scottsdale, Ariz., including the AS2 Accelerator Router, Cyclone Interchange and Cyclone Transaction Director.

The agency plans to use an Oracle9i database to store tracking and audit information from the gateway, which will route the information to center databases. The system also will route data to the e-document room, which will use the Documentum suite of products from EMC Corp. of Pleasanton, Calif., to manage, load and process submissions.

'A benefit of an enterprise architecture that we didn't plan on was the strong response we got from our business leaders, who recognized the need to create a business process planning function that would identify common business processes across the agency,' FDA CIO Jim Rinaldi said.

Each center has its own business processes, around which e-submissions are geared, Gensinger said.

The centers often have common requirements, and they're all re- ceiving documents, 'but our back-office systems are different, and there are different needs for each center,' he said. 'With the architecture, we can look at the commonality between each of the initiatives and leverage that.'

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