PAREXEL EXPERTS TO ADDRESS KEY INDUSTRY TOPICS AT THE DRUG INFORMATION ASSOCIATION 44TH ANNUAL MEETING
BOSTON, MA, June 16, 2008 – Experts from PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services organization, will present in more than 20 sessions at the Drug Information Association (DIA) 44th Annual Meeting. The meeting will be held June 22 - 26, 2008 at the Boston Convention and Exhibition Center in Boston, Massachusetts, home to PAREXEL’s global headquarters office. PAREXEL experts will address key industry topics including global regulatory and drug development strategy, multinational clinical studies, and data-driven patient recruitment, as well as biosimilars, gene therapy regulations, genomics study methods, early-stage biotechnology product development, nanotechnology, and medical imaging biomarkers.
For more than 25 years clients have relied on PAREXEL to provide in-depth expertise in integrated clinical development, medical communications, and regulatory affairs, as well as advanced technologies that help clients expedite time-to-market and peak-market penetration. Attendees at the DIA Annual Meeting can visit PAREXEL experts at Booth #803 in the exhibit hall. Demonstrations of the Company’s technologies, including the market-leading Clinical Trial Management System IMPACT® technology, will be provided by PAREXEL’s technology subsidiary, Perceptive Informatics.
PAREXEL experts will present or chair the following sessions:
Sunday, June 22
A Device Primer: IDEs, 510(k)s, PMAs, and Beyond – Barry Sall, Principal Consultant, PAREXEL Consulting (8:30 a.m. – 12:00 p.m.)
Monday, June 23
Regulatory Strategy as a Key Component of the Global Multidisciplinary Drug Development Strategy: Regulatory Intelligence as a Foundation for Business Success – Paul Bridges, Vice President, PAREXEL Consulting (10:30 a.m. – 12:00 p.m.)
Generic Biologics: Fact or Fiction? The Next Generation of Biosimilars – Cecil Nick, MS, Vice President, Biotechnology, PAREXEL Consulting (1:30 p.m. – 3:00 p.m.)
Hot Topics in Biotechnology: Algorithm for Cell Bank Characterization –Ralf Dieter Hess, PhD, MSc, Principal Consultant, PAREXEL Consulting (3:30 p.m. – 5:00 p.m.)
Tuesday, June 24
Negotiating IT Contracts: Speeding Up the Process and Finding Common Ground: CRO Perspective – Cynthia Grubbs, Vice President of Worldwide Procurement, PAREXEL (8:00 a.m. – 9:30 a.m.)
Doing the Project Planning for Large Multinational Clinical Trials: Key Aspects to Be Considered when Planning and Executing Global Clinical Trials –Session Chair and Speaker: Diego Martin Glancszpigel, MEd, Vice President of Latin American Operations, Clinical Research Services, PAREXEL (8:00 a.m. – 9:30 a.m.)
The European Regulatory Landscape for Gene Therapy Clinical Trials – Beate Roder, PharmD, PhD, Senior Consultant, PAREXEL Consulting (10:00 a.m. – 11:30 a.m.)
Gene Therapy Regulations for EU Clinical Trials: Navigating the Maze– Session Chair: Cecil Nick, MS, Vice President, Biotechnology, PAREXEL Consulting, UK (10:00 a.m. – 11:30 a.m.)
Building a Strong EDC Foundation through the Power of Partnership Trials – Drew Garty, Senior Director, Worldwide EDC Solutions, Clinical Research Services, PAREXEL (10:00 a.m. – 11:30 a.m.)
Deal Makers and Deal Breakers: What Venture Capital Firms Look for in Drug Development Plans– Session Chair: Alberto Grignolo, PhD, Corporate Vice President and General Manager, PAREXEL Consulting (10:00 a.m. – 11:30 a.m.)
Data-driven Patient Recruitment: Tools for Early Planning and Predictive Management: Approaches to Data-driven Site Selection and LPI Planning – Session Chair and Speaker: Joshua Schultz, MS, Vice President, Clinical Research Services, PAREXEL (2:00 p.m. – 3:30 p.m.)
Innovative Medicines and the EMEA: Strategizing for Success in the EU – Session Chair and Speaker: Cecil Nick, MS, Vice President, Biotechnology, PAREXEL Consulting (2:00 p.m. – 3:30 p.m.)
Evolving Natural Health Products Market Size and Its Development. Cosmeceuticals: Marketing Topical Products without Making Licensable Medicinal Claims in Europe – Peter Lassoff, PharmD, Vice President, PAREXEL Consulting (4:00 p.m. – 5:30 p.m.)
Wednesday, June 25
Imaging Biomarker Data Management: Qualification and Validation of Imaging Biomarkers – George Q. Mills, MD, Vice President, Medical Imaging Consulting, Perceptive Informatics (8:30 a.m. – 10:00 a.m.)
Biosimilars/Follow-on Biologics: Unique Aspects of the Development of Follow-On Biologics Products – Session Chair and Speaker: Bruce Babbitt, PhD, Principal Consultant, PAREXEL Consulting (8:30 a.m. – 10:00 a.m.)
The Expanding Use of Genomics Studies Methods, Regulatory Considerations and the Impact on Evidence-Based Medicine – Session Chair: Nayan Nanavati, MS, MT, Vice President Peri Approval, Americas, PAREXEL; Speaker: Ramita Tandon, Director, Project Management, Clinical Research Services, PAREXEL (8:30 a.m. – 10:00 a.m.)
Opportunities and Challenges of Globalizing Clinical Research: Adding Value to Early-stage Biotechnology Product Development – Matthias Grossmann, MD, PhD, Vice President and Principal Consultant, Clinical Pharmacology, PAREXEL (10:30 a.m.– 12:00 p.m.)
Understanding the Regulation of Advanced Therapy Medicinal Products in Europe, Introduction to the New Regulations on Advanced Therapy Medicinal Products – Session Chair and Speaker: Ralf Dieter Hess, PhD, MSc, Principal Consultant, PAREXEL Consulting (1:30 p.m. – 3:00 p.m.)
Outsourcing in China: Opportunities and Challenges Decision Models and Case Study – Session Chair and Speaker: Simon Wang, MBA, MSc, Manager, PAREXEL APEX International (1:30 p.m. – 3:00 p.m)
Nanotechnology Task Force: Regulating Nanotechnology Products, FDA’s Exploratory IND Guidance: Transitioning Nanotechnology Drugs/Biologics – Session Chair and Speaker: George Q. Mills, MD, Vice President, Medical Imaging Consulting, Perceptive Informatics (3:30 p.m. – 5:00 p.m.)
Leveraging Technology to Build an IT Infrastructure for Global Clinical Trials, Scaling EDC Solutions to Meet the Needs of Large-Scale Global Trials – Ian Sparks, Consultant, Worldwide EDC Solutions Group, Clinical Research Services, PAREXEL (3:30 p.m. – 5:00 p.m.)
The DIA Annual Meeting attracts approximately 8,000 attendees, bringing together professionals from the biopharmaceutical and related industries. This year’s meeting will feature nearly 360 sessions across 26 tracks and will cover several hot topics including adaptive trials and methods, patient recruitment and retention, multinational clinical trials, clinical and regulatory considerations for personalized medicine, and various biotechnology related topics.
For more information about PAREXEL visit www.PAREXEL.com or Booth #803 at the DIA Annual Meeting.
# # #
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical 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 63 locations throughout 52 countries around the world, and has more than 7,600 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; 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 period ended March 31, 2008 as filed with the SEC on May 9, 2008, 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 their respective business and are hereby acknowledged.