NEW TEXT FIRST TO PROFILE U.S. BIOLOGICS PRODUCT REGULATION FOLLOWING CBER/CDER CONSOLIDATION
PHILADELPHIA, PA, February 3, 2004 — Barnett International, a division of PAREXEL International Corporation (Nasdaq:PRXL), announced the release of the 2004 edition of Biologics Development: A Regulatory Overview, the first text to analyze the affects of the FDA’s historic transfer of therapeutic biological products to the Center for Drug Evaluation and Research (CDER).
Now in its third edition, Biologics Development: A Regulatory Overview has been a widely read book on Food and Drug Administration (FDA) regulation, review, and approval of therapeutic biologics, vaccines, gene/cellular therapies, and other biological products.
The completely revised 2004 edition fully describes and analyzes the new dual-center regulatory system for biological products following the FDA reassignment of biological products in October 2003. The text describes the emerging organizational structures and review processes for therapeutic products now regulated by CDER, as well as the processes and organization within the Center for Biologics Evaluation and Research (CBER) for the regulation of vaccines, cellular/gene therapies, and blood products.
Written by more than a dozen CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview provides a detailed analysis of preclinical and clinical testing requirements, Investigational New Drug Application (IND) and Biologics License Agreement (BLA) submission requirements, FDA application review structures and processes, and complete regulatory standards for modern biological products.
Biologics 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 57 locations throughout 37 countries around the world, and has 5,050 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, including, without limitation, statements regarding the Company’s existing capital resources and future cash flows from operations, and statements regarding expected financial results, future growth and customer demand, such as the guidance provided by the Company with respect to the third quarter of Fiscal Year 2004, the full Fiscal Year 2004 and Calendar 2004. 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. The Company'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; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth, and attract and retain employees; the Company'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 the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 as filed with the SEC on November 12, 2003, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.