PAREXEL CONSULTING BOLSTERS BIOLOGICS EXPERTISE BY HIRING FORMER FDA, MHRA REGULATORS
Boston, MA, June 15, 2010—PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, announced today that it has appointed former regulators Toby Silverman, M.D. and Keith Watson, Ph.D. as Principal Consultants. These appointments further expand PAREXEL Consulting’s global team of regulatory and product development experts to address a growing need among its clients to support accelerated approvals of innovative biotechnology and blood product platforms.
For 20 years, Dr. Silverman served at the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) and was most recently Senior Advisor in the Office of Blood Research and Review. Dr. Silverman was responsible for key CBER initiatives related to biologic development, pharmacovigilance and hemovigilance, which involved safety monitoring of blood and related components. Dr. Silverman was also formerly Branch Chief of the Clinical Review Branch in the Division of Hematology at FDA.
Dr. Watson joins PAREXEL from The Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K., where he was engaged with key biotechnology advisory groups in Europe, including the Biologicals and Vaccines Expert Advisory Group (BVEAG), Biologics Working Party (BWP) and the Committee for Medicinal Products for Human Use (CHMP). Previously, Dr. Watson held senior level positions within the biopharmaceutical industry, which were focused on biologics manufacturing and quality as well as monoclonal antibody technologies.
“Last year, approximately half of new drug approvals were for novel biotech products, and this area is expected to continue to grow, especially as governments seek to preferentially reimburse life-impacting treatments and biopharmaceutical companies look to commercialize the next generation of innovator and biosimilar products,” said Paul Bridges, Ph.D., Vice President, PAREXEL Consulting. “As our clients increasingly turn to us for specialized biotechnology expertise, PAREXEL Consulting is committed to further expanding our related consulting capabilities to help them accelerate their global development programs. We expect Dr. Silverman and Dr. Watson to provide valuable assistance to our clients’ development programs. They will support our clients in navigating challenging global regulatory environments and creating new regulatory pathways for innovative products that address unmet medical needs.”
PAREXEL Consulting offers biopharmaceutical and device consulting services supporting strategic partnering, product globalization, development optimization, reimbursement and market access, and strategic compliance as well as expertise in biologics, biosimilar and medical device development and commercialization. For more information visit: http://www.PAREXEL.com/services-and-capabilities/consulting/about-PAREXEL-Consulting/.
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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 54 countries around the world, and has approximately 9,500 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,” “will,” “would,” “could,” “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 and anticipated restructurings, including the anticipated restructuring charge of approximately $24 million over the second, third, and fourth quarters of Fiscal Year 2010; 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; 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 March 31, 2010 as filed with the SEC on May 7, 2010 which “Risk Factors” discussion is incorporated by reference in this press 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.