PAREXEL STRENGTHENS REGULATORY EXPERTISE IN EUROPE, APPOINTS PRINCIPAL CONSULTANT
BOSTON, MA, November 5, 2001 — PAREXEL International Corporation, (Nasdaq: PRXL) one of the world’s largest contract biopharmaceutical outsourcing companies, today announced the appointment of Karel J. de Neef, M.D., Ph.D. as Principal Consultant, Regulatory Affairs Europe North Region. In this capacity, Dr. de Neef joins PAREXEL’s global organization of regulatory professionals providing strategic regulatory consulting advice and solutions to accelerate the achievement of clients’ regulatory milestones.
Dr. de Neef brings to PAREXEL over 25 years of experience in academia, the pharmaceutical industry, and with regulatory authorities. Most recently, he led the technical coordination unit for the European Medicines Evaluation Agency (EMEA) with responsibilities for access and maintenance of new medicinal products on the European market. While with the EMEA, he initiated the Agency’s Quality Management System and the quality review of Product Information of Medicinal Products as well as initiatives in relation to electronic submissions such as the joint EMEA/European Federation of Pharmaceutical Industry Association (EFPIA) product information management and the ICH M-2 Guideline. In addition, Dr. de Neef was Program Director of the Pan European Regulatory Forum, a group of regulatory authorities preparing for the enlargement of the European Union.
Prior to this position, Dr. de Neef was International Senior Director, Global Clinical Data Management for Hoffman-La Roche. He also held several clinical management positions with Organon International B.V., AKZO Pharma.
A native of The Netherlands, Dr. de Neef graduated from Leiden University Medical School where he earned his Ph.D., cum laude. Upon completing his training, he held a teaching position at the Technical University Eindhoven, The Netherlands, and was a cardiology and clinical epidemiology fellow at the Thorax Center, Erasmus University, Rotterdam. Dr. de Neef is a member of the editorial board of the Drug Information Journal. His professional memberships include the Teaching Faculty of the European Center of Pharmaceutical Medicine and the Institute for Pharmaceutical Business Administration.
“We are delighted that a professional of such international stature and expertise has chosen to join PAREXEL’s global regulatory affairs consulting practice,” said Dr. Alberto Grignolo, Senior Vice President and General Manager, Worldwide Regulatory Affairs. “From his base in our UK offices, Dr. de Neef will work with our clients around the world to help them achieve their product development, regulatory and business objectives.”
PAREXEL is one of the largest contract biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., provides a variety of technology products and services, including web-based portal solutions and voice and data systems, which are designed to accelerate and enhance the clinical development and launch processes. The Company’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 55 locations throughout 35 countries around the world, and has approximately 4,610 employees.
This release contains "forward-looking" statements regarding future results and events, including statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. 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" and similar expressions are intended to identify forward-looking statements. 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 cancellation, revision, or delay of contracts, including those contracts in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth, 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; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical 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. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Form 10-K for the period ended June 30, 2001, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company disclaims any duty to update any of the forward-looking statements contained in this press release.