PAREXEL EXPANDS CONSULTING CAPABILITIES WITH APPOINTMENTS OF WASHINGTON-D.C. BASED REGULATORY AND PRODUCT DEVELOPMENT EXPERTS
BOSTON, MA, April 11, 2007 — PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global life sciences consultancy serving the bio/pharmaceutical and medical device industries, today announced that it has appointed five new consulting experts, including several former U.S. Food and Drug Administration (FDA) reviewers, to support its growth. The consultants, who have more than 100 years of combined experience in regulatory affairs and product development, are based in PAREXEL’s newly-established Washington, D.C.-area office, located in Bethesda, Maryland.
The team of consultants based in the Washington, D.C.-area office is led by Carolyn Finkle, Vice President of PAREXEL Consulting. The office houses several other PAREXEL experts including former FDA Division Director Dr. George Mills, recently appointed to the position of Vice President of Medical Imaging Consulting for PAREXEL’s subsidiary Perceptive Informatics.
“Our clients require a fusion of scientific, regulatory and business expertise to help them develop products for worldwide bio/pharmaceutical markets,” said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of PAREXEL Consulting. “Our expanding team of consultants in Washington, D.C., many of whom have in-depth experience as former regulators, will assist our clients in gaining regulatory approval for important products.”
PAREXEL Consulting Appointments
- Carolyn Finkle, Vice President at PAREXEL Consulting, has more than 24 years of experience in drug development, regulatory affairs, Good Manufacturing Practice (GMP), pharmacology, drug product safety evaluation, clinical development, post-approval requirements, and scientific research. Ms. Finkle is responsible for management of the product development and regulatory consulting team in North America, focused on helping clients optimize all aspects of the development process for drugs, biologics, devices and combination products. Prior to joining PAREXEL Consulting, Ms. Finkle was Vice President of Regulatory Affairs at Celsion Corporation. Her prior experience includes management of pre-clinical development and drug development for TherImmune Research (now Gene Logic), Gemin X Biotechnologies, and ConjuChem. Ms. Finkle holds a Master of Science degree in chemistry from the University of Toronto and a Bachelor’s degree in chemistry from the University of Ottawa. Ms. Finkle is currently on the faculty of the Pharmaceutical Education and Research Institute.
- Lawrence Grylack, M.D., is a Principal Consultant at PAREXEL Consulting. Prior to joining PAREXEL Consulting, Dr. Grylack served as Medical Officer in the Division of Pediatric Drug Development in the Office of Counterterrorism and Pediatric Drug Development, and the Division of Pulmonary and Allergy Drug Products at the FDA Center for Drug Evaluation and Research (CDER). In this role, he handled reviews of adverse event reports, investigational new drugs (INDs) and new drug applications (NDAs), and performed consultations for other CDER Divisions and other FDA Centers. His 40 years of medical experience include positions as a neonatologist at Columbia Hospital for Women, Georgetown University Hospital, and Fairfax Hospital. Previously, Dr. Grylack taught in the Department of Pediatrics at the Georgetown University School of Medicine, and conducted clinical research. Dr. Grylack is Board Certified in pediatrics and neonatal-perinatal medicine and holds an M.D. from Tufts University School of Medicine, and a Bachelor’s degree from Brandeis University. He was granted fellowships in neonatology from Washington Hospital Center and Georgetown University.
- David Morse, Ph.D., is a Principal Consultant at PAREXEL Consulting. Dr. Morse has more than 20 years of experience in pharmacology and toxicology. Before joining PAREXEL, he worked as a supervisory pharmacologist for the FDA’s CDER, where he provided strategic regulatory oversight for all phases of product development and safety testing for new therapeutics. Dr. Morse's experience includes drug, biologic and combination products for the treatment of a broad variety of indications, with a focus on serious and life threatening disease indications, including infectious diseases and oncology. In his most recent position, Dr. Morse was responsible for the oversight of more than 150 pre-IND, IND, and NDA applications per year. He was awarded his doctorate from the Uniformed Services University of the Health Sciences, in Bethesda.
- Sally Hargus, Ph.D., is a Senior Consultant at PAREXEL Consulting. Dr. Hargus has over 15 years of combined research, industry, and regulatory experience in pharmacology and toxicology aspects of drug development. Prior to joining PAREXEL Consulting she held senior positions in toxicology, including with 3M Pharmaceuticals and with the FDA’s Center for Biologics Evaluation and Research (CBER), where she reviewed pharmacology and toxicology sections of IND, pre-IND, and biologic license application (BLA) submissions for vaccines and allergenic products. Dr. Hargus received the 2006 CBER Director’s Award for outstanding performance as a member of RTSS Malaria Vaccine Working Group. Dr. Hargus holds a Ph.D. and Master’s degree in pharmacology from the University of Rochester School of Medicine, and a Bachelor’s degree in biology from Augustana College, in South Dakota.
- Patrick Guinn is a Manager at PAREXEL Consulting. Prior to joining PAREXEL Consulting Mr. Guinn served as Consumer Safety Officer/Regulatory Health Project Manager at the FDA’s CDER. With more than 10 years of FDA experience Mr. Guinn’s expertise includes preparation and facilitation of FDA regulatory meetings and negotiations, coordination of activities for multi-disciplinary review teams, management of the drug review process, and development of several regulatory Guidances documents for the industry. His career at the FDA includes serving in the Office of Drug Safety and Division of Oncology Drug Products. He holds a Bachelor’s degree in biology from Virginia Tech.
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications 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, to facilitate the clinical development process. 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 December 31, 2006 as filed with the SEC on February 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.