Board Certified Toxicologist Brings Nearly Three Decades of Pharmaceutical
Industry Experience and Leadership
CINCINNATI, Oct. 1 /PRNewswire-FirstCall/ -- Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced the appointment of Ken Hintze, PhD, as Vice President, Global Clinical Safety and Pharmacovigilance. Dr. Hintze will lead the continued growth and development of Kendle's global clinical safety and pharmacovigilance business, including safety services in support of Phase I-IV trials as well as stand- alone safety projects. Dr. Hintze most recently was Senior Director, Global Clinical Safety and Pharmacovigilance and has been instrumental in advancing Kendle's safety organization to the global resource it is today.
"Patient safety remains among our highest priorities at Kendle," noted Melanie Bruno, PhD, Vice President, Global Regulatory Affairs and Quality. "With increasingly complex safety regulations worldwide, our global network of experts ensures both regulatory compliance as well as patient health and welfare. We are very pleased to have Dr. Hintze in this important global role and look forward to his ongoing leadership and expertise as we focus on meeting our customers' needs for high-quality safety services."
With more than 100 safety experts based in nine locations worldwide, Kendle offers a globally-connected network of safety experts experienced in working within the regulatory requirements of any country. The company's safety organization develops risk management plans, coordinates global regulatory reporting - including Suspected Unexpected Serious Adverse Reaction (SUSAR) reports as well as periodic reports - and performs endpoint adjudication utilizing a new proprietary electronic endpoint adjudication system that increases both speed and accuracy. The organization is proficient in the full spectrum of safety database systems and can maintain databases internally or within a customer's system via secure connections. The Safety organization works closely with Kendle's Medical Affairs group in reviewing adverse events to provide customers with comprehensive medical monitoring and safety services.
Dr. Hintze brings nearly 30 years of safety and regulatory experience to this position. He joined Kendle in 2002 following 23 years at Procter & Gamble in various safety roles involving pharmaceutical and consumer products, including Section Manager, Information Systems and Data Management and North America Product Safety Surveillance; and Section Manager, Global Corporate Toxicology and Consumer Health and Safety Affairs. Dr. Hintze earned Doctorate and Master of Science degrees in pharmacology/toxicology from the University of Iowa and a Bachelor of Science in chemistry from Iowa State University. He is a member of numerous medical and scientific societies, including the Society of Toxicologists. Dr. Hintze is a widely-published author, as well as an accomplished speaker presenting at numerous professional conferences and symposia. He is based in Cincinnati and reports to Dr. Bruno.
Kendle International Inc. (Nasdaq: KNDL) 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.
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.
|SOURCE Kendle International Inc.|
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