FDA ENDORSES CDISC STANDARDS DEVELOPMENT AT INTERCHANGE

AUSTIN, Texas – 20 October 2003 – Dr. Mark McClellan, Commissioner of the U.S. Food
and Drug Administration (FDA), gave the keynote presentation at Interchange 2003, the
inaugural industry-wide meeting of the Clinical Data Interchange Standards Consortium
(CDISC), held Sept. 29-Oct. 2 in Bethesda, Maryland. In his address Dr. McClellan spoke highly
of the CDISC efforts towards standardization.

“There could be no more important challenge than trying to harness the incredible potential of new information tools to enable better, more affordable, less error prone healthcare. And there could be no more important partner for us in this endeavor than CDISC. We all share the same mission -- to transform how information flows through all segments of the health care system in order to improve the health and health care of every American,ln McClellan said.

Central to achieving this goal, and to mastering our growing IT sophistication, is the
development of standards that allow us to exchange digital information. The standards you are
developing are the centerpiece for our vision of how our own IT infrastructure is going to
improve drug development. I™m committed to making sure that when your work is complete, that
we work toward their adoption,lt McClellan continued in his speech.

The conference also included presentations from the US, Europe and Japan by representatives of major pharmaceutical companies, contract research organizations, technology/service providers, FDA, and CDISC. They spoke of the progress made in standards development and how the CDISC standards are being implemented and harmonized across the realm of clinical trial data exchange, from protocols through submissions, and collaboratively through Health Level Seven (HL7) to link with healthcare standards.

The CDISC standard for the exchange of clinical trial laboratory data is now approved as an HL7 Reference Information Model (RIM) Version 3 message, in addition to the original ASCII, SAS and XML implementation options. The CDISC standard to support interchange of other clinical trial operational data is available in Version 1.2 as an XML schema. The CDISC Version 3 submission data standards have been approved as an HL7 informative document, and the CDISC analysis data models are currently being evaluated by a group of FDA statistical reviewers.

The first two days of the Interchange included standards development team meetings, tutorials and workshops. On October 2, FDA held an open public meeting on the CDISC Version 3 Submission Data Standards (SDS). This CDISC standard is currently being piloted by FDA reviewers and statisticians with nine major global pharmaceutical companies. The resulting version of these standards (SDS Version 3.1) is scheduled to be directly referenced by FDA Guidance by mid 2004. The SDS Version 3.1 will simultaneously be balloted by HL7.

Representatives of the FDA noted during the public meeting that they will accept submissions in the SDS Version 3 today (with the addition of a set of Demographics selection variables), since it adheres to the existing FDA Guidance for eSubmissions. However, they are looking forward to the completion of Version 3.1.

“The use of the CDISC standards enables the FDA to employ a standard set of review tools. This will substantially improve the current process because it will facilitate their work as well as expand their review capabilities, such as analyzing cross-trial databases. The sooner the pharmaceutical industry submits eSub data compliant with these standards, the sooner we could see an overall gain in efficiencies in the review and approval process and the sooner the drugs reach the patients. In the end, everyone wins.” said William J. Qubeck, IV, Global Head of Electronic Submissions Data, Pfizer, Inc.

Presentations from the Interchange and the FDA public meeting will be available on the CDISC and FDA websites, as follows: www.cdisc.org (Presentations and Events)
http://www.fda.gov/cder/regulatory/ersr/default.htm (Recent Presentations).

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor-neutral, platform- independent standards to improve data quality and accelerate product development in the pharmaceutical industry.

CDISC is made possible through the generous support of its members, sponsors, and volunteer participants. Additional information on CDISC and the CDISC open standards/models can be found on the CDISC website at http://www.cdisc.org.

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For more company information view the website or contact: Shirley Williams, Director of Finance and Operations, CDISC, swilliams@cdisc.org , Julie Evans, Manager Technical Services, jevans@cdisc.org, or Rebecca Kush, Ph.D., President, CDISC, rkush@cdisc.org