PAREXEL EXPERTS TO PRESENT LEADING INSIGHTS AT DRUG INFORMATION ASSOCIATION 45th ANNUAL MEETING
Boston, MA, June 3, 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) 45th Annual Meeting, being held from June 21 – 25, 2009 in San Diego, California. A number of PAREXEL’s thought leaders will present on topics ranging from global development strategies, clinical logistics in emerging regions, clinical trial metrics, and drivers of investigator performance to conducting multinational trials, optimizing adaptive trial designs, preparing pharmacovigilance documents, and securing venture funding for drug development plans. PAREXEL experts will also discuss best practices for creating immunogenicity strategies, developing safe and effective biological medicines, and addressing regulatory challenges related to second generation therapeutic proteins.
PAREXEL International—Booth #1701
A complimentary white paper, entitled “Best Practices: Non Clinical Trial Safety,” will be provided at PAREXEL’s Booth #1701. A global team of PAREXEL experts will be available for on-site exclusive executive briefings and to discuss the Company’s model for achieving optimal efficiency and effectiveness in clinical development. These experts will also address partnering best practices, including strategic guidance and creative solutions to help biopharmaceutical companies meet milestones and overcome key challenges. Other capabilities that will be presented by PAREXEL to support the successful development and commercialization of biopharmaceutical products include global market access, regulatory consulting, Phase I - IV programs, advanced technology, reimbursement, safety/pharmacovigilance, and medical communications.
Perceptive Informatics—Booth #1707
Perceptive Informatics, a subsidiary of PAREXEL and the industry’s leading eClinical solutions provider, will introduce a new interoperable solution to simplify workflow, enhance information sharing, and improve decision making. Experts will be available at Booth #1707 to discuss how Perceptive Informatics is changing the way technology is used in clinical trials. Attendees that visit Perceptive’s booth will be able to view demonstrations of eClinical software focused on increasing the efficiency and productivity of clinical research. These include Perceptive’s DataLabs® Electronic Data Capture (EDC) system and two Clinical Trial Management Systems (CTMS)—the IMPACT® solution designed for global biopharmaceutical companies, and the TrialWorks® solution, which is designed for small and mid-sized companies.
The DIA Annual Meeting program features the following sessions, which will be chaired or presented by PAREXEL experts:
Sunday, June 21
- A Device Primer: 510(k)s, PMAs, IDEs and Beyond (Tutorial 57)—Barry Sall, RAC, Principal Consultant, PAREXEL Consulting (1:30 p.m. – 4:30 p.m.)
Monday, June 22
- Optimizing Adaptive Trial Designs: Methodology and Impact on Supplies—Graham J. Nicholls, M.S., Associate Director, Client Account Management, Perceptive Informatics (10:30 a.m. – 12:00 p.m.)
- The New “Next Door” in Global Development: When East Goes West or West Goes East—Session Chair and Speaker: Carolyn Finkle, M.Sc., Vice President, Global Product Development Strategy, PAREXEL Consulting (1:30 p.m. – 3:00 p.m.)
- Immunogenicity: Strategies for Testing and Evaluation—Ralf Dieter Hess, Ph.D., M.Sc., Principal Consultant, PAREXEL Consulting (3:30 p.m. – 5:00 p.m.)
- A La Carte or Prix Fixe: The Right Menu for Clinical Trials Technology—Drew Garty, Senior Director, Worldwide EDC Solutions, Clinical Research Services, PAREXEL (3:30 p.m. – 5:00 p.m.)
Tuesday, June 23
- Understanding the Complexities of Latin American Borders and Local Regulations to Get Clinical Trial Material into the Country—Session Chair: Claudina Mariel Berciano, RPh, Director of Clinical Logistics Services, Latin America (8:00 a.m. – 9:30 p.m.)
- Clinical Trial Performance Metrics: Development of the Beta Version—April Davis, M.A., Senior Director, eClinical Technology Services, Perceptive Informatics (8:00 a.m. – 9:30 a.m.)
- Regulatory Challenges Related to the Development of Second Generation Therapeutic Proteins—Session Chair: Bruce Babbitt,h.D., Principal Consultant, PAREXEL Consulting (10:00 a.m. – 11:30 a.m.)
- Deal Makers and Deal Breakers: What Venture Capital Firms Look for in Drug Development Plans and How Applicants Succeed (or Fail) in Winning Funding—Session Chair: Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy and Services, PAREXEL Consulting (2:00 p.m. – 3:30 p.m.)
Wednesday, June 24
- Developing Safe and Effective Biological Medicines—Cecil Nick, B.Sc. (Hons), Vice President, Biotechnology, PAREXEL Consulting (10:30 a.m. – 12:00 p.m.)
- Lessons Learned from Doing Large Multinational Clinical Trials—Diego Martin Glancszpigel, M.Ed., Vice President, Latin America, Clinical Research Services, PAREXEL (1:30 p.m. – 3:00 p.m.)
Thursday, June 25
- Pharmacovigilance from the Medical Writer Perspective: Preparing Pharmacovigilance Documents in a CRO—Session Chair and Speaker: Julia Cooper, Ph.D., Senior Director, Worldwide Head of Medical Writing Services, PAREXEL (8:30 a.m. – 10:00 a.m.)
- Investigator Outreach Analysis: Using Performance and Survey Data as Drivers of Investigator Performance—Session Chair: Joshua Schultz, M.S., Vice President, Clinical Research Services, PAREXEL (10:30 a.m. – 12:00 p.m.)
For more information about PAREXEL visit www.PAREXEL.com or Booth #1701, and for more information about Perceptive Informatics visit www.perceptive.com or Booth #1707. Information about DIA’s 45th Annual Meeting can be found at www.diahome.org.
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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 69 locations throughout 52 countries around the world, and has over 9,400 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 March 31, 2009 as filed with the SEC on May 8, 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.