PAREXEL CONSULTING EXPANDS RISK MANAGEMENT EXPERTISE, APPOINTS FDA INVESTIGATOR SPECIALIST ANTHONY C. WARCHUT
BOSTON, MA, September 6, 2006 — PAREXEL Consulting, a leading global life sciences consultancy and division of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it has expanded its risk management and strategic compliance expertise with the appointment of Anthony C. Warchut, formerly an investigator in the U.S. Food and Drug Administration (FDA) Pharmaceutical Inspectorate. Mr. Warchut brings 29 years of FDA pharmaceutical inspection experience to PAREXEL Consulting, and joins a global network of consultants dedicated to addressing the full range of risk management challenges facing companies.
Mr. Warchut’s extensive experience includes serving as an investigator in the Pharmaceutical Inspectorate, a cadre of specially trained experts, selected among the FDA’s most experienced drug specialists, who have experience with complex products, technologies and advanced pharmaceutical manufacturing processes. The Pharmaceutical Inspectorate was established as a result of the FDA’s “Pharmaceutical current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach,” a major global initiative to ensure the quality of drug products. In addition to the complex, high risk cGMP inspections Mr. Warchut conducted as part of the Pharmaceutical Inspectorate his experience also includes inspections of sponsor/monitors, clinical investigators, bioequivalence laboratories and non-clinical laboratories, as well as inspections involving the FDA’s Application Integrity Policy.
“Tony is the first of the Pharmaceutical Inspectorate cadre to leave the FDA and join industry and we are proud that he selected PAREXEL Consulting,” said Gadi Saarony, General Manager of the Strategic Compliance and Operational Excellence Practice at PAREXEL Consulting. “Tony brings the deep expertise our clients need to help assure product quality and safety and to proactively identify and manage risks associated with biopharmaceutical product and medical device development.”
Mr. Warchut joins PAREXEL Consulting’s team of premier experts who have extensive backgrounds in the FDA of more than 20 years, including Corporate Vice President Ronald Tezlaff, Ph.D, Vice President David Chesney, Vice President Terry Muson, and Vice President Peter Smith.
“PAREXEL Consulting brings together a fusion of expertise, represented by consultants with FDA crisis management and risk management backgrounds, with business processes and metrics that are required not only to help clients respond to FDA actions but also to better prepare and improve their long-term performance,” said Kurt Brykman, President of PAREXEL Consulting and Medical Marketing. “We help our clients apply our well-established risk management approach, focused on maximizing value while ensuring quality, across the drug development and compliance continuum, including clinical, manufacturing, and drug safety/event reporting environments.”
About PAREXEL Consulting
A leading, independent, life sciences consultancy, PAREXEL Consulting is focused exclusively on the life sciences industry and serves biopharmaceutical and medical device clients with its unique fusion of scientific, regulatory and business expertise. PAREXEL Consulting focuses on helping clients design and execute their product strategies, while managing risk and improving quality and performance. The firm has approximately 250 employees in seven major office locations in the U.S. and Europe, and serves clients on a global basis. For further information visit: www.PAREXELConsulting.com. PAREXEL Consulting is a division of PAREXEL International.
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and integration services. Headquartered near Boston, Massachusetts, PAREXEL operates in 51 locations throughout 40 countries around the world, and has approximately 5,600 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains "forward-looking" statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. 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,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release 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 which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the amendment or interpretation of Financial Accounting Standards Board Statement No. 123 (revised 2004), Share-Based Payment (“Statement 123R”), which could change the Company’s current assessment of the effects of the adoption of Statement 123R on the acceleration of equity grants, the assumptions inherent in equity pricing models under Statement 123R and the final results of the closing of the Company’s books for future financial periods; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, 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; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and 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 period ended March 31, 2006 as filed with the SEC on May 9, 2006, 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.
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 business and are hereby acknowledged.