CINCINNATI, Aug. 10 /PRNewswire-FirstCall/ -- Kendle , a leading, global full-service clinical research organization, today announced that Timothy Forsey, PhD, has joined the company as Principal Regulatory Affairs Consultant specializing in providing regulatory affairs guidance to the company's biotechnology customers. Based in Kendle's Ely, Cambridgeshire, England office, he will work with customers to gain regulatory approval for both new marketing authorizations and changes to existing marketing authorizations. Dr. Forsey will provide customers with advice on strategy and regulatory approaches to development, interact on their behalf with regulatory agencies and assist them with dossier preparation.
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"As biotechnology's overall contribution to the health care arena continues to grow, so will the demand for outsourcing services, as new therapies move from preclinical to the clinical phases of drug development," said Melanie Bruno, PhD, Vice President Global Regulatory Affairs and Quality. "Tim Forsey's experience with this customer group and in the regulatory environment will be a tremendous asset to our biotech and pharmaceutical customers seeking to move their new compounds from discovery to market approval," she added.
Dr. Forsey previously served as Head of Biologicals and the Biotechnology Unit for The Medicines and Healthcare products Regulatory Agency (MHRA), where he was involved with a variety of licensing and scientific issues, and represented the United Kingdom on the Biologics Working Party of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA). He also worked as Senior Director, Head of European Regulatory Affairs for Shire Human Genetic Therapies, Ltd. Prior to that, Dr. Forsey worked for Pharmacia, Amgen, the National Institute for Biological Standards and Control and the University of London. In all, he brings more than 30 years of pharmaceutical, governmental and research experience to his role with Kendle.
Dr. Forsey earned a doctorate in microbiology from the University of London and a Bachelor of Science in microbiology from the University of Surrey, England. A widely-published author, he is a registered member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and the Drug Information Association (DIA).
Dr. Forsey is the latest member of an international team of pharmaceutical, clinical and non-clinical biotechnology experts Kendle has assembled with backgrounds encompassing regulatory agencies on three continents, as well as experience working for a variety of pharmaceutical companies and academic and research institutions.
About Kendle
Kendle International Inc. is among the world's leading global clinical research organizations and is the fourth-largest provider of Phase II-IV clinical development services worldwide. We deliver innovative and robust clinical development solutions - from first-in-human studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share.
Our global clinical development business is focused on five regions - North America, Europe, Asia/Pacific, Latin America and Africa - to meet customer needs. With the expertise of our more than 3,000 associates worldwide, Kendle has conducted clinical trials and provided regulatory and pharmacovigilance services in more than 80 countries. The company was named the "Top CRO to Work With" in the Thomson CenterWatch 2007 Survey of U.S. Investigative Sites.
Additional information and investor kits are available upon request from Kendle, 441 Vine Street, Suite 1200, Cincinnati, OH 45202 or from the Company's Web site at http://www.kendle.com.
Forward-Looking Statements
This release contains information about management's view of Kendle's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, those set forth in the "Risk Factors" section of the Company's latest Form 10-K and other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point, the Company specifically disclaims any obligation to do so other than as required by federal securities laws. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.
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