PAREXEL APPOINTS FORMER SENIOR FDA OFFICIAL DAVID ELDER TO GLOBAL TEAM OF STRATEGIC COMPLIANCE EXPERTS
BOSTON, MA, January 17, 2012 –PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global consultancy serving the biopharmaceutical and medical device industries, today announced that David Elder, formerly a senior official of the U.S. Food and Drug Administration (FDA), has been appointed as a Vice President to its Strategic Compliance Services team. This appointment further expands the PAREXEL global team of regulatory and compliance experts who help clients navigate an increasingly complex regulatory environment, and institute proactive strategic compliance practices to guide the success of their products.
At the FDA, Mr. Elder served as the Director of the Office of Regional Operations (ORO) within the Office of Regulatory Affairs (ORA) where he managed a team of professionals working around the globe to ensure that regulated products met the FDA's standards, rules and regulations. Previously, Mr. Elder was Director of the Office of Enforcement within ORA. Prior to this position, he served in the FDA’s New England District Office as an investigator, compliance officer, and as Director of the Compliance Branch.
During his 23 year tenure with the FDA, Mr. Elder was involved in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. As Office Director for both Enforcement and Regional Operations, he was a principal advisor to the Associate Commissioner of Regulatory Affairs at the FDA.
"The appointment of Mr. Elder to the PAREXEL team of regulatory and strategic compliance experts reinforces our commitment to help clients proactively manage the risk of potential safety issues and product delays and failures on a global scale," said David L. Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL Consulting. "We expect that his extensive experience in conducting inspections and knowledge in areas such as global product safety and quality will greatly benefit our clients."
PAREXEL Consulting provides integrated product development consulting services, helping biopharmaceutical companies shorten time to market and maintain product viability for the long-term. Expertise provided by PAREXEL Consulting includes strategic regulatory partnering, product globalization, and development optimization, as well as solutions that deliver effective alignment of development and commercialization strategies. PAREXEL Consulting experts also provide capabilities in development of leading edge products such as biosimilars, therapeutic vaccines, and combination products. For information regarding PAREXEL Consulting’s Strategic Compliance services visit http://www.PAREXELConsulting.com/services/strategic-compliance.html.
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications 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 67 locations throughout 52 countries around the world, and has approximately 10,850 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,” “should,” “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 additional restructuring charges of approximately $4 million in the second quarter of Fiscal Year 2012; 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 September 30, 2011 as filed with the SEC on November 9, 2011, 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.