Board-Certified Regulatory Affairs Professional Brings More Than Two
Decades of Pharmaceutical, Regulatory Agency and Research Experience
CINCINNATI, Feb. 1 /PRNewswire-FirstCall/ -- Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced the hiring of Satish Tripathi, PhD, RAC as Vice President, Global Regulatory and Quality. Dr. Tripathi will provide additional leadership to the Regulatory Affairs Brand, overseeing the multi-functional global regulatory group consisting of approximately 450 personnel. He will focus on driving growth in the company's regulatory brand, which includes strategic clinical development planning, regulatory consulting and submissions, clinical trial regulatory affairs, nonclinical consulting, Chemistry, Manufacturing and Controls (CMC) development, medical writing and pharmacovigilance/safety services.
"We are thrilled to have someone with Satish's background and experience as part of our regulatory leadership team," said Melanie Bruno, PhD, Vice President, Global Regulatory Affairs, Quality and Safety. "His ability to analyze the regulatory complexities of drug development and fashion a market positioning strategy to help ensure commercial success will provide a wonderful resource to Kendle's customers."
Dr. Tripathi served most recently as the Director of Worldwide Regulatory Strategy at Pfizer (formerly Pharmacia). Prior to that, he was a Director of Global Regulatory Affairs at the Biosciences Division of Baxter Healthcare Corporation in charge of all global regulatory submissions within the Recombinant Strategic Business Unit. While at the U.S. Food and Drug Administration, Dr. Tripathi served as a Pharmacology and Toxicology Reviewer with an emphasis on oncology and pulmonary products.
Dr. Tripathi earned his doctorate from the University of Glasgow in Scotland, his Master of Philosophy from Bhopal University in India and bachelor's and master's degrees from Jiwaji University at Gwalior, India. His post-doctoral fellowships include the Massachusetts Institute of Technology, Emory University Medical School and the Medical College of Wisconsin.
Dr. Tripathi will be based in Kendle's Chicago office.
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.
Our global clinical development business is focused on five regions -- North America, Europe, Asia/Pacific, Latin America and Africa -- to meet customer needs. We have 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 and named "Best CRO" for the second consecutive year by leading global pharmaceutical publication Scrip.
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.
|SOURCE Kendle International Inc.|
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