Innovator of the ethnobridging approach, PAREXEL helps biopharmaceutical industry accelerate global development
Boston, MA /PRNewswire/ -- PAREXEL International Corporation (NASDAQ: PRXL ), a leading global biopharmaceutical services provider, announced today that it has achieved a significant milestone by completing its 100th Asian ethnobridging study, which is designed to help biopharmaceutical companies accelerate development for the Asia/Pacific market. PAREXEL is the innovator of the ethnobridging study —an approach to determine safety and tolerability, as well as possible pharmacokinetic and pharmacodynamic differences, in target ethnic populations. The goal of these studies is to assist PAREXEL clients in saving time and development costs in their global early phase programs.
"PAREXEL created the ethnobridging study concept, which was built on decades of experience in the science and practice of ethnically-sensitive clinical programs," said Sy Pretorius, M.D., M.S., M.B.A., Corporate Vice President and Worldwide Head of Early Phase. "Our pioneering ethnobridging approach assists clients in expediting early phase approval of compounds in certain international markets."
According to Dr. Pretorius, "The inclusion of Asian countries in global drug development strategies and registration of drugs in the Asia Pacific region have become increasingly important in recent years. To help our clients to fast-track development in Asian countries, PAREXEL applies leading-edge expertise through Asian ethnobridging studies to collect Chinese, Japanese and Korean data in the U.S. and UK for registration regionally in Asia. Achieving the milestone of our 100th Asian ethnobridging study reinforces our commitment to help biopharmaceutical companies prepare and execute global development plans for emerging regions, and bring new treatments to patients in Asia."
PAREXEL has enrolled over 3,500 subjects in Asian ethnobridging studies. Early phase experts at PAREXEL conduct Asian ethnobridging studies at its accredited sites in the U.S. and UK. These sites have access to an Asian population of over 1.2 million people, which allows PAREXEL to perform studies that conform to the regulatory requirements of China, Japan and Korea. PAREXEL experts have worked closely with Asian regulators to design studies, conducted outside of Asia for acceptance by the Asian regulators, that adhere to the International Conference on Harmonization (ICH) E5 guideline. PAREXEL provides consultation on regulatory issues, protocol designs and analysis of data with relation to ethnobridging studies. The Company has a proprietary database and a dedicated enrollment team with experience in various specialized recruitment methods and access to some of the largest populations of first-generation Asians outside of Asia.
PAREXEL assists biopharmaceutical companies to manage development costs, accelerate development timelines and obtain earlier efficacy signals. PAREXEL accomplishes this by leveraging early phase capabilities that include a global capacity of beds and full scope of early phase studies and services—from concept to study report and beyond, with integrated services to prepare clients for later phase studies. PAREXEL has extensive, relevant experience and in-depth expertise to assist clients with ever more complex early-phase trial design and execution, as well as efficient delivery of better, faster go/no-go decisions from First-in-Human (FIH) through Proof-of-Concept. PAREXEL provides specialized trial designs, state-of-the-art technologies, biomarkers, and scientific expertise. With hospital-based units in the U.S., Europe, and South Africa, as well as a network of alliance sites, PAREXEL provides clients with excellent patient access specific to key therapeutic areas for early phase development. For more information about PAREXEL's early phase development capabilities visit: http://www.PAREXEL.com/services-and-capabilities/early-phase .
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 52 countries around the world, and has approximately 10,350 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 restructuring charge of approximately $15 million over the fourth quarter of Fiscal Year 2011 as well as the first and second quarters 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 March 31, 2011 as filed with the SEC on May 10, 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.
SOURCE PAREXEL International Corporation