PAREXEL INTERNATIONAL FURTHER STRENGTHENS REGULATORY EXPERTISE IN EUROPE
BOSTON, MA, March 4, 2002 — PAREXEL International Corporation, (Nasdaq: PRXL) one of the world’s largest biopharmaceutical outsourcing companies, today announced the addition of two former UK regulators, Sandy M. Eisen, M.D. and David J. Snodin, Ph.D. as Principal Consultants in the Worldwide Regulatory Affairs group. In this capacity, Dr. Eisen and Dr. Snodin join Dr. Karel de Neef, formerly an official at the EMEA, in complementing the experienced team reporting to Carrol Marcus in PAREXEL’s Uxbridge, UK office, providing pharmaceutical and regulatory consulting advice and solutions to global biopharmaceutical clients.
Dr. Eisen has been a Senior Medical Officer with the Medicines Control Agency (MCA) for thirteen years, and has experience with all aspects of regulatory affairs. Most recently Dr. Eisen was Senior Medical Assessor in the New Drugs Unit, where he was responsible for the preparation of reports and assessments for regulatory advisory bodies such as the Committee on Safety of Medicines (CSM) and the Committee for Proprietary Medicinal Products (CPMP). As an integral part of the New Drugs Unit, Dr. Eisen has been involved with the assessment of European applications for New Active Substances in all therapeutic areas. He has attended CPMP and its working parties and groups as an expert. Additional MCA responsibilities have included assessment of biological, abridged and CTX (clinical trials) applications and provision of policy advice. Dr Eisen has presented and lectured on a wide variety of topics covering all areas of European regulatory affairs. Dr. Eisen was awarded a B.A. in Medical Sciences and earned his Medical Qualification from Cambridge University. He received his Postgraduate Surgical Degree from the Royal College of Surgeons, London and his Diploma in Pharmaceutical Medicine from the Royal College of Physicians, London.
Dr. Snodin brings to PAREXEL over 30 years of experience in academia, the food industry pharmaceutical research & development, regulatory affairs and toxicology. Most recently, he worked as an Expert Preclinical Assessor with the Medicines Control Agency (MCA). He possesses in-depth knowledge and experience of European drug development procedures and was the UK member of the CPMP Safety Working Party. He has been a frequent speaker at workshops and symposia on various aspects of regulatory pharmaco-toxicology. Prior to MCA, Dr. Snodin acted as a Scientific Consultant to the food and pharmaceutical industries focusing on toxicology, safety and regulatory affairs. Previously he was employed at Tate and Lyle Group Research and Development as a Safety and Regulatory Affairs Manager and as a Senior Analyst with the Scientific Services Department of Avon County Council providing compliance advice and analysis of food, pharmaceuticals, air and water. Upon graduating from the Royal College of Science, Imperial College with a degree in Chemistry, Dr. Snodin earned his Ph.D. in Organic Chemistry from the University of Bristol. Dr. Snodin also holds Masters of Sciences degrees in Chemical Analysis, Toxicology and Applied Statistics and is a Fellow of the Royal Society of Chemistry.
“We are delighted to welcome Dr. Eisen and Dr. Snodin to our regulatory team,” said Alberto Grignolo, Ph.D., Senior Vice President, Worldwide Regulatory Affairs. “Their extensive collective knowledge of regulatory requirements and of the biopharmaceutical industry will be instrumental helping us to maintain a leading position in Regulatory Consulting.”
PAREXEL is one of the largest contract pharmaceutical 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 36 countries around the world, and has approximately 4,660 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 here in that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends" and "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-Q for the period ended December 31, 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.