MEDIA ADVISORY: PAREXEL CONSULTING EXPERTS TO PROVIDE KEY INSIGHTS INTO EARLY-STAGE VACCINE DEVELOPMENT AND FOLLOW-ON BIOLOGICS
BOSTON, MA, January 27, 2009 — Experts from PAREXEL Consulting, a leading global consultancy serving the biopharmaceutical and medical device industries, and business unit of PAREXEL International (NASDAQ: PRXL), will present key insights related to the early-stage development of therapeutic vaccines today at the Phaciliate Vaccines Forum. PAREXEL consulting experts will discuss the development of follow-on biologics as part of a Windover Webinar scheduled for February 5, 2009.
“Strategic Challenges in Early-Stage Development of Therapeutic Vaccines,” Phacilitate Vaccine Forum
Bruce Babbitt, Ph.D., Principal Consultant, PAREXEL Consulting will facilitate this working lunch today, January 27, 2009, from 12:50 p.m. – 2:00 p.m. at the Phacilitate Vaccine Forum, which is being held at the Grand Hyatt Hotel in Washington, D.C. The following panelists, with broad expertise in the areas of Chemistry, Manufacturing and Controls (CMC), Nonclinical, Clinical, and Regulatory Affairs, will provide guidance to attendees on vaccine development, including ways to reduce associated time and costs:
• Norman W. Baylor, Ph.D., CBER, U.S. Food & Drug Administration
• Drew M. Pardoll, M.D., Ph.D., Johns Hopkins University School of Medicine, Baltimore
• Ravi Harapanhalli, Ph.D., PAREXEL Consulting
• David Morse, Ph.D., PAREXEL Consulting
The Phaciliate Vaccine Forum is the 7th annual North American meeting for senior level industry executives driving the development of novel therapeutic vaccines. For more information about the forum visit: www.phacilitate.co.uk.
“Part I: Preparing for the Changing Regulatory Landscape of Follow-on Biologics,” Windover Webinar
In Part I of a two-part webinar series, entitled “How to Compete in the Brave New World of Follow-On Biologics,” presenters will focus on key development factors and challenges specific to follow-on biologics. In addition, an update on legislative and regulatory actions expected for this product group will be presented, as well as an example of how one company is currently approaching the follow-on biologics market. The webinar will feature the following speakers:
• Bruce Babbitt, Ph.D., Principal Consultant, PAREXEL Consulting
• Cecil Nick, Vice President, Biotechnology, PAREXEL Consulting
• Ravi Harapanhalli, Ph.D., Principal Consultant, PAREXEL Consulting
• Glenn Kelley, Vice President of Regulatory Affairs and Intellectual Property, Insmed Inc.
• Kate Rawson, Regulatory Bureau Chief for FDC-Windover’s Biopharma Group
More information about the webinar, which will be held on February 5, 2009 at 12:00 p.m. Eastern, can be found at www.parexelconsulting.com.
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About PAREXEL Consulting
PAREXEL Consulting, a division of PAREXEL International, provides integrated product development services with the goal of helping biopharmaceutical and medical device companies get their products to the market, and keep them on the market. Through a unique fusion of scientific, regulatory, and business expertise PAREXEL Consulting helps clients worldwide manage risk and maximize product and portfolio value at every milestone and during each phase of development.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications 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, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 51 countries around the world, and has over 9,250 employees. For more information about PAREXEL International visit www.PAREXEL.com.
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,” “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 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, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; 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 quarter ended September 30, 2008 as filed with the SEC on November 7, 2008, 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 PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.