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25-Year Veteran of FDA Recognized for Commitment to Public Health and Safety
CINCINNATI, May 9, 2005 -- Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced Anthony C. Celeste is one of three recipients of the 2005 FDA Distinguished Alumni Award. Celeste, who has dedicated his 45-year professional life to serving the public and upholding the FDA's mission and values, received the agency's highest honor at its annual awards ceremony May 6.
"Tony's ultimate concern has always been the public's health and safety," said Candace Kendle, Chairman and CEO of Kendle. "Throughout his tenure, he's been viewed as a trusted advisor to biopharmaceutical companies throughout the world as they work to bring their products to the marketplace. This latest award from the FDA may be the crowning accomplishment on Tony's long list of honors and achievements."
Celeste spent 25 years with FDA, concluding his career there as director of the agency's Office of Regional Operations, the unit responsible for managing and directing the field force of investigators, analysts, compliance officers and administrative staff. In this position, he had day- to-day management responsibility for all field office activities.
Celeste's most recent experience has been with AAC Consulting Group, Kendle's Regulatory Affairs consulting subsidary in Rockville, Maryland. He served as President of AAC for more than 20 years and since 2004 has worked as Senior Vice President. While at AAC, Celeste has been involved in the full range of FDA-regulated products and practices and has provided assistance to companies regarding enforcement, strategic planning for regulatory compliance, interpretation of Good Manufacturing Practices (GMPs) and many other issues.
Celeste is the previous recipient of several FDA honors and awards of merit, including the Distinguished Service and Leadership Award from the Food and Drug Law Institute (FDLI). He has published several papers on regulatory topics and is co-author of Application of Pharmaceutical cGMPs, published by FDLI. In addition, he is writing How to Prepare for an FDA Inspection, due for release during 2005, as part of a six-book series published by FDAnews.
Kendle International Inc. (Nasdaq: KNDL) is among the world's leading global clinical research organizations. 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. With the expertise of our more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmacovigilance and validation services in 70 countries. 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