CINCINNATI, March 16 /PRNewswire-FirstCall/ -- Kendle , a leading, global full-service clinical research organization, today announced that Thomas B. Smith, MD, has joined the company as Global Medical Director. In this role, he provides medical and therapeutic expertise to Phase I-IV clinical development projects and proposals for the company’s biopharmaceutical customers, with an emphasis on projects in the Central Nervous System (CNS) therapeutic area. Dr. Smith brings to Kendle significant experience in CNS drug development, having led a clinical team in the preparation and submission of an Investigational New Drug (IND) for a novel compound for Alzheimer’s disease. He also was involved in the successful filing of a supplemental new drug application (sNDA) of Depakote(R) ER for bipolar mania to the United States Food and Drug Administration. CNS is an important focus area for Kendle, with the company’s experience including more than 500 CNS projects in 53 countries involving nearly 110,000 patients.
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“CNS now ranks as the second most researched therapeutic area worldwide in terms of drug development,” said Martha Feller, PhD, Senior Vice President, Global Clinical Development. “Dr. Smith’s expertise in this area will further strengthen our therapeutic experience in this significant and growing area of global clinical development.”
Dr. Smith brings nearly 20 years of pharmaceutical industry experience to Kendle. Serving most recently as Senior Director, Clinical Research and Development, Akros Pharma Inc., he was responsible for assisting in the implementation and execution of clinical studies and for the preparation of clinical sections of regulatory submissions for new products and therapies. Prior to that, he served as Medical Director, Global Research and Development, Genzyme Corporation, and Associate Medical Director, Neuroscience Development, Abbott Laboratories. Dr. Smith’s background includes working across all phases of drug development and the full spectrum of therapeutic areas.
This is critically important as the focus in drug development continues to shift beyond simply bringing a new compound to market toward effectively managing the entire life cycle of each drug.
Dr. Smith earned a Doctor of Medicine from Indiana University School of Medicine and a Bachelor of Science from Purdue University. He is a member of the American Medical Association, American Academy of Family Physicians and the American Council for Headache Education. A widely-published author, Dr. Smith also has delivered more than 150 scientific presentations.
Forward-Looking Statement
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.
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 “Best Contract Research Organization” in November 2006 by an independent panel for Scrip World Pharmaceutical News.
Additional information and investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202 or from the Company’s Web site at www.kendle.com.
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CONTACT: Lori Dorer, +1-513-345-1685, Investors: Patty Frank,+1-513-763-1992, both of Kendle International Inc.
Web site: http://www.kendle.com/
