BOSTON, June 13 /PRNewswire-FirstCall/ -- Experts from PAREXEL International Corporation , a leading global bio/pharmaceutical services provider, will present key topics at the Drug Information Association’s (DIA) 43rd Annual Meeting in Atlanta, GA, to be held June 17 - 21, 2007 at the Georgia World Congress Center. Dr. Alberto Grignolo, PhD, Corporate Vice President and General Manager of Drug Development Consulting for PAREXEL International and the DIA Annual Meeting Chairperson, will give the meeting’s opening remarks. Attendees will hear PAREXEL experts discuss issues such as risk management, regulatory compliance, patient enrollment, quality assurance, EU regulations and more.
PAREXEL experts will present or chair the following sessions: Monday, June 18 * Opening Remarks/Plenary Session -- Alberto Grignolo, PhD, Corporate Vice President and General Manager, Drug Developing Consulting, PAREXEL Consulting (8:30 -- 10:00 a.m. ET) * Personalized Medicine and Personalized Drug Development: Case Studies and Progress to Date -- Part 1 of 2 -- Alberto Grignolo, PhD, Corporate Vice President and General Manager, Drug Developing Consulting, PAREXEL Consulting (1:30 -- 3:30 p.m. ET, room B407) Tuesday, June 19 * Risk Management in Clinical Trials -- Holger Liebig, Director of Project Management, PAREXEL International (2:00 -- 3:30 p.m. ET, room B402) Wednesday, June 20 * Process Validation During Clinical Development of Biological Medicinal Products -- Session Chair: Cecil Nick, MS, Director, PAREXEL Consulting (8:30 -- 10:00 a.m. ET, room B304) * Introduction and Impact of European Directives -- Cecil Nick, MS, Director, PAREXEL Consulting (8:30 -- 10:00 a.m. ET, room B304) * Optimizing EU Regulatory Strategy -- Session Chair: Cecil Nick, MS, Director, PAREXEL Consulting (10:30 a.m. -- 12:00 p.m. ET, room A406) * My Drug is Approved -- Now What? Overview of Required Post-Approval Documents -- Julia Cooper, PhD, Senior Director, Worldwide Head of Medical Writing Services (10:30 a.m. -- 12:00 p.m. ET, room B405) * The Advantages of Quality by Design (QbD) Implementation for Emerging Companies -- Irach Taraporewala, PhD, Senior Consultant, PAREXEL Consulting (1:30 -- 3:00 p.m. ET, room A301) * Biosimilars in Europe: The EU Regulatory Environment for Biosimilars -- Dr. Gerald Haase, FRCPath, Principal Consultant, Drug Development Consulting Practice, PAREXEL Consulting (1:30 -- 3:00 p.m. ET, room A402) * Outsourcing and Late Phase Studies: What to Do, What Not to Do and Why -- Session Chair: Ramita Tandon, MA, MPH, Director, Project Management, Peri-Approval Clinical Excellence, PAREXEL International (1:30 -- 3:00 p.m. ET, room B401) * Quality Issues and the Spectrum of Complexity -- Cecil Nick, MS, Director, PAREXEL Consulting (3:30 -- 5:30 p.m. ET, room B304) * Compassionate Use of Supply of Unlicensed Products in Europe and Beyond -- Susan Sandler, BSc (Hons), MRPharmS, Dip Reg Aff, Principal Consultant, PAREXEL Consulting (3:30 -- 5:30 p.m. ET, room A405) * Role of Ex-Japan Clinical Pharmacology Studies (Ethnobridging) in Expediting Japanese Drug Development -- Stanford S. Jhee, PharmD, Director of Research, California Clinical Trials, PAREXEL International (3:30 -- 5:30 p.m. ET, room A406) * Global Clinical Trials and Polyethnic Patient Enrollment: Implications for Regulatory Approval of Marketing Applications -- Session Chair: Alberto Grignolo, PhD, Corporate Vice President and General Mgr, Drug Development Consulting Practice, PAREXEL Consulting (3:30 -- 5:30 p.m. ET, room B407) Thursday, June 21: * Gene Therapy Regulations for EU Clinical Trials: Navigating the Maze -- Cecil Nick, MS, Director, PAREXEL Consulting (8:30 -- 10:00 a.m. ET, room B301)
For the past 25 years, clients have relied on PAREXEL to provide integrated clinical development, regulatory affairs consulting and commercialization services, as well as technologies that expedite time-to- market. Attendees at the DIA Annual Meeting can visit with PAREXEL’s speakers at Booth #724 in the exhibit hall. Demonstrations of PAREXEL’s advanced technologies, including clinical trial management systems, patient recruitment planning technology and drug supply forecasting and visualization software provided by PAREXEL’s subsidiary, Perceptive Informatics, will also be available.
The DIA Annual Meeting is a key industry event, attracting more than 8,000 attendees from 65 countries. The event brings together professionals from bio/pharmaceutical and related industries who are involved in all areas of bio/pharmaceutical development. This year’s meeting boasts nearly 400 sessions, 1,000 speakers and 27 newly added tracks covering current hot topics such as Adaptive Trials/Adaptive Methods, FDA Critical Path Global, Clinical Trials Multi-track and Personalized Medicine.
For more information about PAREXEL visit www.PAREXEL.com or Booth #724 at the DIA’s 43rd 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 marketing 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, Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and integration services. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 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, 2007 as filed with the SEC on May 9, 2007, 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.
PAREXEL International Corporation
CONTACT: Karen Wills, Vice President, Corporate Marketing of PAREXELInternational, +1-781-434-5301, Karen.Wills@PAREXEL.com; or Rebecca Passoof SHIFT Communications, +1-617-779-1817, rpasso@shiftcomm.com
Web site: http://www.parexel.com//
