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Biopharmaceutical Company ILEX Oncology turns to CDC Solutions for Electronic Regulatory Submissions.


Business Editors/High-Tech Writers

PHILADELPHIA and CHIPPENHAM, UK--(BUSINESS WIRE)--June 17, 2002

- Researcher and developer of anti-cancer compounds anticipates

time-to-market benefits with the EZsubs publishing tool -

CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
 Solutions Ltd. (www.cdcsolutions.com), the leading global provider of document-based solutions to the life sciences industries, announced today that ILEX Ilex

a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly.
(TM) Oncology, Inc. (Nasdaq:ILXO), an oncology-focused biopharmaceutical company committed to bringing to market novel treatments for cancer patients, has selected the EZsubs(R) publishing suite from CDC Solutions to facilitate electronic publishing An umbrella term for non-paper publishing, which includes publishing online or on media such as CDs and DVDs.  and submissions to regulatory bodies throughout the world. ILEX has a marketed drug, CAMPATH(R) in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and MABCAMPATH(TM) in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
, and is advancing an innovative and diversified pipeline of additional compounds focused on the treatment of cancer.

Michael Bernstein, Senior Director of Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
 at ILEX, said, "EZsubs from CDC Solutions will afford us the ability to compile electronic regulatory submissions and internal reports more accurately and in a fraction of the time it formerly took us to do the work manually. We evaluated several options in the search to find the optimal publishing tool for our needs, including various products and toolkits, but none offered the benefits that we found with EZsubs. Only CDC Solutions provided the ease of use, integration and support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services , and implementation timeframe that fit into the overall objective of having a complete publishing solution in place quickly."

EZsubs is a highly scaleable publishing solution that supports electronic and paper outputs, and is designed to facilitate mission-critical reports and submissions to the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ), the U.S. Food & Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), and other regulatory bodies throughout the world.

EZsubs works with an existing document management system or file system for reports, amendments, and regulatory submissions.

Bernstein added, "As one of the few companies focused primarily on the development and commercialization of oncology drugs, we needed a tool to manage every piece of the process flow throughout the research and development of the submission, tracking all changes made in each associated document from pre-clinical reports all the way through the New Drug Application stage. From a bottom line standpoint, the primary benefit of EZsubs to ILEX is that it streamlines the end-to-end process, which we hope will allow us to reduce the time to market for our anti-cancer compounds. If you can save even one or two months in the review process at the FDA, EMEA, or any other regulatory body across the globe, you can get to market that much faster, which could make a critical difference in the lives of patients and enhance revenue for the company as well."

ILEX anticipates full implementation of EZsubs by September 2002.

Philip Padfield, Chief Executive Officer of CDC Solutions, said, "It's always extremely rewarding when leading life sciences companies evaluate the many publishing options in the industry and in turn select CDC Solutions. This reinforces our belief that taking the time to learn about our customers' goals and to provide solutions that support their needs is a superior approach to trying to force a square peg into a round hole. Otherwise, we would find it much more difficult to earn the business and trust of respected companies such as ILEX Oncology. We're very excited to have them on board."

About ILEX Oncology, Inc.

Founded in 1994 as an oncology drug development company, ILEX is strategically positioned to become a product-driven, oncology-focused biopharmaceutical company. ILEX has a marketed product, CAMPATH(R) in the United States and MABCAMPATH(TM) in the European Union, and is advancing an innovative and diversified pipeline of compounds focused on the treatment of cancer.

The ILEX pipeline comprises product candidates at various stages of clinical development, including cytotoxic cy·to·tox·ic
adj.
Of, relating to, or producing a toxic effect on cells.



cyto·tox·ic
 and cytostatic cytostatic /cy·to·stat·ic/ (sit?ah-stat´ik)
1. suppressing the growth and multiplication of cells.

2. an agent that so acts.


cy·to·stat·ic
adj.
1.
 agents with novel mechanisms of action, monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). , angiogenesis inhibitors, and signal transduction inhibitors. ILEX maintains a core competency in oncology drug development, with locations in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation).
San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S.
 and Guildford, England.

ILEX also conducts research in angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.

an·gi·o·gen·e·sis
n.
 inhibition, cell signaling, medicinal chemistry, and nuclear receptor biology at its laboratories in Boston, Massachusetts, and Geneva Geneva, canton and city, Switzerland
Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva.
, Switzerland. Further information about ILEX can be found on the company's web site at www.ilexonc.com.

About CDC Solutions Ltd.

Founded in 1994, CDC Solutions is the leader in high performance document-based solutions to the Life Sciences industries. The open, flexible technologies developed by CDC Solutions enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver reports and submissions reliably on time.

CDC Solutions helps compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity: all of which contribute to ensuring patients' and physicians' timely access to new drugs.

CDC Solutions develops products in-house, employing a team of developers and regulatory specialists who actively pilot new initiatives with clients and partners. Through its strategic business partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance.

For more information, call +44 1249 705300 (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, EZsubs, PDFfusion, PDFrender, PDFaqua, PDFcontrol, Xtensia, Xssembler, and Xport are trademarks or registered trademarks, service marks or registered service marks of CDC Solutions Ltd. All other product and company names mentioned herein may be trademarks of their respective holders.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:Biopharmaceutical Company ILEX Oncology turns to CDC Solutions for Electronic Regulatory Submissions.
Publication:Business Wire
Geographic Code:4EUUK
Date:Jun 17, 2002
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