CDC Solutions and Boehringer Ingelheim Developing Pilot Program for Electronic Submissions with XML-based Cumulative Table of Contents.

Business Editors/Hi-Tech Writers

PHILADELPHIA--(BUSINESS WIRE)--April 11, 2001

FDA taking steps to include an XML-based electronic Cumulative

Table of Contents for the Investigational New Drug Application

CDC Solutions (CDC), a world-leader in multi-channel content delivery for regulatory and enterprise-scale publishing, today announced the launch of a pilot program to develop a proof-of-concept platform for a new prototype for Investigational New Drug (IND) electronic submissions as outlined recently by the Center for Drug Evaluation and Research (CDER), a branch of the Food and Drug Administration (FDA).

The prototype will be designed to integrate an XML-based platform for an electronic Cumulative Table of Contents (CTOC) with PDF and SAS XPORT documents with the main body of the report.

CDC Solutions will be working closely with one of its major clients, Boehringer Ingelheim, a global pharmaceutical organization headquartered in Ingelheim, Germany, to create a prototype that meets the practical needs of the pharmaceutical industry as well as the requirements of the FDA.

The solution is designed to support future specifications as the International Conference on Harmonization (ICH) completes the electronic Common Technical Document (CTD) project.

As part of an extensive and on-going project at the FDA to shift from paper to electronic submissions, CDER recently proposed the use of an electronic CTOC as part of the electronic submission process for INDs.

While the use of an electronic CTOC benefits both the submitting pharmaceutical company and the CDER review teams, development of an implementation program has the potential to be cumbersome for the pharmaceutical companies, costing them significant investment of time and money to develop a feasible solution.

Dr. Dirk Ehrhard, Global Project Leader for Document Management at Boehringer Ingelheim said, "The importance of the CTOC project is that it maps out the direction in which the regulatory bodies are moving - toward a more user-friendly electronic submission process. In anticipation of the FDA's addition of an XML-based navigation, pharmaceutical companies around the world will have a definite target to aim for in terms of putting a new electronic structure in place. CDC Solutions is leveraging its existing technology to take an active role in this development, which is a critically important step toward a more efficient submissions process."

Don Palmer, Regulatory Specialist at CDC Solutions added, "On average, IND submissions may comprise anywhere from 10-30 volumes, each consisting of several hundred pages. On the high end, however, we have seen submissions in the 50-70 volume range. Add to that as many as 500 amendments associated with a particular IND, and it is easy to understand the need for submission-level organization. The dynamic nature of an XML-based CTOC makes sense logically, and is a technology that CDC already uses in its publishing software products. The CTOC concept greatly improves the navigation and searching capabilities for the FDA reviewers, as well as the sponsor pharmaceutical company."

The CTOC, which usually consists of several sub-TOCs, provides a means of keeping all related submissions, amendments and supplements organized and readily accessible through the navigation search tool.

In an effort to advance and speed the review process, CDER suggested moving toward adding a non-proprietary, XML-based platform for the CTOC in addition to the currently accepted paper format or PDF and SAS XPORT format.

This is expected to improve the overall organization and navigation of IND submissions, amendments and supplements, as well as reduce the time reviewers will need to locate the most recent information.

CDC's pilot proposal is based on open technology and the use of a standard approach. Because XML is positioned as the lead technology in the CDC pilot, seamless integration of XML and PDF files will be a key benefit to companies with a variety of document sources.

Companies that use this solution will therefore not be required to also invest in proprietary technology, which is an obvious cost savings. Similarly, the implementation process will be shortened as maintenance and training issues are minimized in comparison to alternative, proprietary solutions.

The electronic CTOC solution developed by CDC for the pilot will be readily transferable to nearly any pharmaceutical company, facilitating rapid response as CDER develops its recommendations for electronic submissions. It will work in an online network, document management system or Web-enabled environment - a useful flexibility as the changes to the submission process continue to develop.

Throughout the pilot with Boehringer Ingelheim, CDC will also be working with SciLucent LLC, a consulting firm whose services cover the entire life cycle of healthcare products from early stage due diligence for in-licensing and partnerships through development, registration, and post-marketing activities.

SciLucent will take an active part in developing a white paper based on the results of the pilot program.

Allison Goldfarb, a Consultant at SciLucent said, "In our experience, advancing the latest technologies for submission preparation can contribute to the development of well-informed and useful regulatory guidelines by FDA. Initiatives such as this pilot program can also surpass the goal of meeting the FDA's expectations and create important tools for efficient information management and compliance throughout product development. We look forward to working with CDC Solutions on evaluating and publishing the pilot information, which companies can then use to make a smooth transition that not only meets the proposed CDER guidelines, but also ultimately improves development practices and simplifies the submission process."

About CDC Solutions, Inc.

CDC Solutions is a World-leading provider of multi-channel content delivery publishing solutions that accelerate the assembly, dissemination and publishing of enterprise-scale publishing for paper, Intranets and the Web.

Since its foundation in 1994, CDC Solutions has guided companies on Corporate Publishing techniques and offered a range of solutions that comply with industry formats including XML, HTML, PDF, TIFF, GIFF and JPEG.

Working closely with global partners such as Documentum Inc., Adobe Systems, Lotus and Qumas, CDC Solutions has built an enviable reputation for high quality advanced technology coupled with an unrivaled team of experienced consultants and implementers to deliver corporate knowledge benefit.

CDC Solutions' electronic publishing products are in use by leading Pharmaceutical, Finance, Insurance, Utilities, Automotive and Media organizations both on a departmental and an enterprise level. Today, CDC Solutions is defining the way organizations publish corporate knowledge from simple personalized documents to high scale regulatory submissions.

For more information, call [phone] (United Kingdom) or 610/824-9021 CDC Solutions, Inc. (North America), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, CDC Solutions Inc., EZsubs Publishing Suite, PDFfusion, PDFrender, PDFtools, PDFaqua, PDFcontrol, and Xtensia are trademarks or registered trademarks of CDC, Ltd.(c)2001 CDC Solutions Inc. All other product and company names mentioned herein are trademarks of their respective holders.