PAREXEL EXPANDS LEADING IMAGING EXPERTISE, APPOINTS FORMER FDA DIVISION DIRECTOR GEORGE MILLS TO VICE PRESIDENT, MEDICAL IMAGING CONSULTING
BOSTON, MA, February 6, 2007 — PAREXEL International Corporation (NASDAQ: PRXL), a leading global bio/pharmaceutical services organization, today announced that it has appointed George Q. Mills, M.D., to the position of Vice President, Medical Imaging Consulting for Perceptive Informatics, a PAREXEL Company. Dr. Mills, who formerly served as Division Director of Medical Imaging and Hematology Products in the Office of Oncology Drug Products, part of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), will advise bio/pharmaceutical clients on how to use medical imaging for strategic decision making and in support of regulatory submissions for their products.
“George is a leading, highly respected medical imaging expert who uniquely combines in-depth scientific knowledge with more than 13 years of regulatory agency experience. We expect him to make tremendous contributions in guiding our clients’ use of imaging results for earlier and more effective go/no-go decision making. We believe his guidance and direction will be invaluable to clients in designing clinical trials and supporting regulatory submissions, as well as in using imaging techniques to help demonstrate evidence of safety and efficacy for their products,” said Mark A. Goldberg, M.D., President of Clinical Research Services and Perceptive Informatics at PAREXEL International.
“I am pleased to join such a high-caliber team of global experts at PAREXEL and to be part of Perceptive Informatics, which is a leader in the imaging field. I look forward to working with the Perceptive team to bring advanced imaging techniques to the next level to help clients further improve decision making and accelerate clinical development,” said Dr. Mills.
In his recent position as Division Director at the FDA, Dr. Mills was responsible for the review and approval of diagnostic and radiolabeled therapeutic drugs and biologics. He managed a staff of 40 professionals involved in the review of the Radioactive Drug Research Committee (RDRC) program, therapeutic and imaging Investigational New Drug Applications (INDs), Biologic License Applications (BLAs) and New Drug Applications (NDAs). He was also actively involved with the FDA’s Critical Path Initiative since its inception in 2004.
Previously, Dr. Mills held several senior roles at the FDA, including Branch Chief and designated Acting Deputy Division Director of the Biologics Oncology Division at the Center for Biologics Evaluation and Research (CBER) and CDER. In these roles, he served as Medical Chief, providing expertise in medical diagnostic imaging and therapeutic radiopharmaceutical oncologic biologics and drugs. He also served as the CBER/CDER expert in conjunction with the review of radiographic imaging submissions in support of licensure submissions.
Dr. Mills has spoken at numerous industry conferences and has published articles in scientific journals and industry publications on imaging and related regulatory topics, including the FDA Critical Path Initiative. He has been certified by the American Board of Nuclear Medicine and the American Board of Pathology, Anatomic and Clinical Pathology. Dr. Mills holds a Medical Degree from Creighton University in Omaha, Nebraska, a Masters in Business Administration degree from Pepperdine University, and a Bachelor of Arts degree from the University of Nebraska.
About Perceptive Informatics, a PAREXEL Company
PAREXEL’s Technology Division, Perceptive Informatics, combines clinical knowledge, quality and regulatory experience with advanced technology to decrease time to market, risk and cost associated with clinical trials. Perceptive’s portfolio includes Medical Imaging, Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS & IWRS), and Integration Services as well as web-based portal solutions, tracking tools, electronic diaries and investigator database solutions. Perceptive offers medical imaging services to rapidly and objectively assess the safety and efficacy of new drugs, biologics and medical devices in clinical trials. The IMPACT™ solution is Perceptive’s market-leading CTMS product with 25,000 users worldwide, and Perceptive’s INITIATOR™ trial management product targets the needs of Phase I units. For more information about Perceptive Informatics, visit www.perceptive.com.
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 56 locations throughout 43 countries around the world, and has over 6,215 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 September 30, 2006 as filed with the SEC on November 9, 2006, 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.