TETZLAFF NAMED HEAD of KMI/PAREXEL, INC.
BOSTON, MA, June 8, 2000 — KMI/PAREXEL, Inc., a subsidiary of PAREXEL International Corporation (Nasdaq:PRXL), announced the appointment of Ronald F. Tetzlaff, Ph.D., as President, effective June 1, 2000. Dr. Tetzlaff will replace P. Michael Masterson, co-founder of the company, who will continue on as a Management Consultant. In his new role, Dr. Tetzlaff will also hold the position of Corporate Vice President, PAREXEL.
Dr. Tetzlaff has been with KMI/PAREXEL for seven years, most recently as the Vice President, Compliance Service, directing and coordinating the activities of a group of former Food and Drug Administration (FDA) and industry experts who provide consulting assistance to clients in the pharmaceutical and medical device industries. KMI compliance consultants assist clients to be ready for successful inspections by the FDA and international regulatory authorities including: compliance audits and mock FDA inspections, assistance in responding to FDA citations and sanctions, reengineering of quality assurance programs and documentation systems, data integrity assessments, technical assistance to client legal counsel, documentation practices for product development that support technology transfer and scale up, and the design and delivery of training programs related to these activities.
Before joining KMI/PAREXEL, Dr. Tetzlaff held the position of the FDA’s National Expert on Parenteral Drugs and Sterilization specializing in GMP Audits on a worldwide basis. During his 27 year career with the FDA and since joining KMI/Parexel, Dr. Tetzlaff has been active in industry programs on validation and GMP and has made many presentations on GMP-related topics at various FDA training courses and national/international industry symposia. He has published many articles and textbook chapters on topics related to FDA inspections and GMP compliance.
Dr. Tetzlaff holds Doctor of Philosophy and Master of Science degrees in Pharmaceutics from the University of Georgia and a Bachelor of Arts degree in Zoology from the University of Washington.
KMI/PAREXEL was founded in 1989 by Dr. Clarence Kemper and P. Michael Masterson to address the validation requirements of computer-controlled processes in FDA-regulated pharmaceutical, biotechnology and medical device industries. A GMP Compliance Services Group, headed by Dr. Tetzlaff, was formed in 1993. Today, KMI/PAREXEL is recognized worldwide for providing GMP Compliance Consulting by former FDA experts and Validation Services by experienced process and software engineers. The company also has a software development division, which offers GMPwareTM Intelligent Software Tools. KMI/PAREXEL was acquired by PAREXEL in 1997.
This release may contain “forward-looking” statements regarding future results and events, including statements regarding expected future growth and customer demand. 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: the cancellation or delay of contracts; the Company’s dependence on certain industries and clients; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses; 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. These factors and others are discussed more fully in the section entitled "Risk Factors" of the Company'’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2000.
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 accelerate 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. 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 in Boston, Mass., PAREXEL operates in 43 locations throughout 29 countries, and has approximately 4,275 employees.