PAREXEL EXPERTS TO PRESENT LEADING INSIGHTS AT DRUG INFORMATION ASSOCIATION 21st ANNUAL EUROMEETING
Boston, MA, March 5, 2009 – Experts from PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, will address important industry issues at the Drug Information Association (DIA) 21st Annual EuroMeeting, being held from March 23 – 25, 2009 in Berlin, Germany. A number of PAREXEL’s thought leaders will present on topics ranging from global biosimilar development programs, medical device and combination products, and clinical process validation to early stage compound selection and pharmacovigilance reporting. PAREXEL experts will also discuss best practices for managing risk in supplier selection, integrating eClinical technologies, and conducting clinical trials multi-nationally and in emerging regions.
A complimentary European Union (EU) Pediatric Investigation Plan (PIP) Advisory from PAREXEL Consulting, with an update and guidance on how biopharmaceutical companies should address the new PIP requirements, will be provided at PAREXEL’s Booth #1522. PAREXEL experts will also be available at the booth to hold exclusive executive briefings with companies on emerging EMEA/FDA cooperation regarding new drug reviews, strategic regulatory partnering, follow-on biologics, and portfolio analysis among other key topics.
Attendees to PAREXEL’s booth will be able to view a demonstration of the DataLabs® Electronic Data Capture (EDC) and Clinical Data Management System (CDMS) from Perceptive Informatics, which is focused on improving the efficiency and data quality of clinical studies. The system incorporates the advantages and flexibility of hybrid technology, unifying paper data entry and EDC into a single clinical data management platform.
The DIA EuroMeeting program features the following sessions, which will be presented or chaired by PAREXEL experts:
Monday, March 23
- The PSUR: A Pharmacovigilance and Medical Writing View with Emphasis on Practical Solutions to The Pitfalls and Grey Areas (tutorial) – Alison Rapley, B.Sc., Director, Clinical Research Services (9:00)
Tuesday, March 24
- Integration of Technology: Today’s Fad or Tomorrow’s Standard? – Bill Byrom, Ph.D., Vice President, Product Strategy, Perceptive Informatics (9:00)
- ePRO Soup to Nuts: The Application of ePRO in Clinical Trials – Keith Wenzel, Senior Director, Product Management, ePRO, Perceptive Informatics (11:00)
- Process Validation During Clinical Development of Biological Medicinal Products – Cecil Nick, B.Sc. (Hons), Vice President, Biotechnology, PAREXEL Consulting (14:00)
- Doing the Project Planning for Large Multinational Clinical Trials – Diego Martin Glancszpigel, Vice President, Latin America Operations (14:00)
- A Risk-Based Approach to Supplier Selection – Siegfried Schmitt, Ph.D., Principal Consultant, PAREXEL Consulting (16:00)
- A Global Programme for the Next Generation in Biosimilars – Session Chair: Cecil Nick, B.Sc. (Hons), Vice President, Biotechnology, PAREXEL Consulting (16:00)
Wednesday, March 25
- Borderlines: Don’t Fence Me In – Peter Lassoff, Pharm D, Vice President, Europe, PAREXEL Consulting (9:00)
- Selecting Promising New Compounds Earlier by Tapping into Modern Safety and Pharmacological Mechanism in Early Exploratory Clinical Research – Matthias Grossman, M.D., Ph.D., Vice President and Principal Consultant, Early Development (9:00)
- The Next Generation of EDC Integration – David Stein, Vice President, Product Management, Perceptive Informatics (9:00)
- Medical Devices and Drug Device Combinations – Esther Gil, Director, PAREXEL Consulting (14:00)
- Challenges, Risks and Benefits of Conducting Clinical Trials in Developing Regions – Graciela Racaro, Senior Director, Clinical Research Services (16:00)
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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 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 December 31, 2008 as filed with the SEC on February 9, 2009, 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.