EDWIN RIVERA-MARTINEZ, FORMER CHIEF OF THE FDA’S INTERNATIONAL COMPLIANCE BRANCH, JOINS PAREXEL CONSULTING STRATEGIC COMPLIANCE TEAM
BOSTON, MA, November 4, 2010— 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 Edwin Rivera-Martinez, B.S., M.B.A., former Chief of the U.S. Food and Drug Administration’s (FDA) International Compliance Branch, has been appointed as a Technical Vice President to its Strategic Compliance Services team, reporting directly to the Practice Lead. This appointment further expands the Company’s global team of regulatory and compliance experts, which supports clients in navigating the increasingly complex regulatory environment and institutes proactive strategic compliance practices to help guide the success of their products.
Mr. Rivera-Martinez served for over 33 years at the FDA, including most recently as Chief of the FDA’s International Compliance Branch, within the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance, Center for Drug Evaluation and Research (CDER), which oversees human drug and active pharmaceutical ingredients (API) inspections conducted internationally by the FDA. From December 2002 to July 2009, he served as Chief of the Manufacturing Assessment and Preapproval Compliance Branch in DMPQ, where he directed the Agency’s human drug preapproval inspection program. In that role, he assured the validity of data in applications and Current Good Manufacturing Practice (CGMP) compliance of both domestic and foreign manufacturing establishments referenced in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and supplements as well as biologics license applications (BLAs) and BLA supplement (BLS) applications for therapeutic biological drugs regulated by CDER.
As the Agency’s leading drug expert on the International Conference on Harmonization (ICH) Q7 Expert Working Group, Mr. Rivera-Martinez played a key role in the development and implementation of the ICH guidance entitled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”. For the last two and a half years, he also served as the Agency’s technical drug CGMP expert on the ICH Q11 Expert Working Group tasked with developing an internationally harmonized guidance for the development and manufacture of drug substances.
From 1990 to 2002, Mr. Rivera-Martinez served as Compliance Officer in DMPQ. Prior to transferring to CDER, he worked for 13 years as an Investigator in the FDA’s San Juan, Puerto Rico District office, where he specialized in the inspection, auditing, and investigation of complex, state-of-the-art active pharmaceutical ingredient and drug production facilities. From 1988 to 1990, while in San Juan, he participated in a joint Pan American Health Organization (PAHO)/FDA cooperative program. As a Regional Consultant in PAHO’s Essential Drugs Program, he coordinated and presented six drug quality assurance and CGMP training courses in Latin America that resulted in the training of over 400 drug regulatory authority and industry personnel.
“The appointment of Mr. Rivera-Martinez to PAREXEL’s team of strategic compliance and regulatory experts reinforces our commitment to helping clients proactively manage the risk of potential safety issues, as well as product delays and failures on a global scale,” said David L. Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL Consulting. “Extremely well-versed in regulations, CGMP compliance and enforcement, as well as ICH guidance, he brings a level of technical and regulatory knowledge that we expect will significantly contribute to the support of our clients’ development programs, and help to guide successful pathways for their innovative products.”
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, development optimization, reimbursement and market access, and strategic compliance. PAREXEL Consulting experts also provide capabilities in development of leading edge products such as follow-on biologics, therapeutic vaccines, and combination products. For information regarding PAREXEL Consulting’s Strategic Compliance services visit http://www.PAREXELConsulting.com/services/strategic-compliance.html.
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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 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 71 locations throughout 54 countries around the world, and has approximately 10,170 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, 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 Annual Report on Form 10-K for the year ended June 30, 2010 as filed with the SEC on August 27, 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.