BARNETT RELEASES NEW DRUG DEVELOPMENT: A REGULATORY OVERVIEW
PHILADELPHIA, PA, December 13, 2004 — Barnett International, a division of PAREXEL International Corporation (Nasdaq:PRXL), has announced the release of New Drug Development: A Regulatory Overview, which features what is now one of the most comprehensive analyses of the drug regulatory process within the United States, the world’s most lucrative pharmaceutical market.
Now in its seventh edition, New Drug Development: A Regulatory Overview is already one of the most widely read texts on the FDA’s regulation, review, and approval of new pharmaceuticals. This latest edition has been updated and expanded to address the effects of pharmacogenomics and other emerging new technologies, the FDA’s new good review management principles (GRMP) initiative, and the agency’s emerging Pharmaceuticals cGMPs for the 21st Century initiative. The text is also the first to chronicle how a comprehensive reorganization within the Center for Drug Evaluation and Research (CDER) will affect new drug reviews going forward.
New Drug Development: A Regulatory Overview is the only text to provide an “inside” look at the FDA and its review and approval divisions, processes, and requirements. In addition, it provides a detailed analysis of U.S. preclinical and clinical testing requirements, IND and NDA submission requirements, and complete regulatory standards for modern biological products.
New Drug Development: A Regulatory Overview is available for $145 per copy by calling 800-856-2556, x2200 or by ordering online at www.barnettinternational.com.
PAREXEL is one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., develops and offers a portfolio of innovative technology-based products and services that facilitate clinical drug development and are designed to decrease time to peak sales. The technology portfolio includes web-based portal solutions and tracking tools, Interactive Voice Response Systems (IVRS), Clinical Trial Management Systems (CTMS), electronic diary and investigator database solutions. Perceptive also offers advanced medical diagnostics services to assess rapidly and objectively the safety and efficacy of new drugs, biologics, and medical devices in clinical trials. PAREXEL’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 51 locations throughout 35 countries around the world, and has approximately 4,875 employees.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of their respective owners and are hereby acknowledged.
This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends", "appears", "estimates", "projects" and similar expressions are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. PAREXEL's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts; PAREXEL's dependence on certain industries and clients; PAREXEL's ability to win new business, manage growth, and attract and retain employees; PAREXEL's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry; competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of PAREXEL’s Annual Report on Form 10-Q for the quarter ended September 30, 2004 as filed with the SEC on November 8, 2004, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent PAREXEL’s estimates as of the date of this release. PAREXEL specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing PAREXEL’s estimates or views as of any date subsequent to the date of this press release.