Flamm and Barnett to Aid Industry in FDA Approval of Food and Color
Additives/New Dietary Ingredients
CINCINNATI, Jan. 27 /PRNewswire-FirstCall/ -- Kendle International Inc.(Nasdaq: KNDL), a leading full-service contract research organization, today announced that its regulatory consulting subsidiary, AAC Consulting Group has entered into an exclusive relationship with W. Gary Flamm, Ph.D., and has hired James W. Barnett, Jr., Ph.D., to further expand its services to the food and dietary supplement industries. Both toxicologists will assist AAC clients to determine the safety of food and dietary ingredients and to prepare submissions to the FDA for review and approval.
"Gary and Jim's combined industry experience and knowledge will be a valuable asset to Kendle and AAC as we continue to focus on expanding our regulatory consulting business," said Kendle Chairman and Chief Executive Officer Dr. Candace Kendle. "They will play an important role in our efforts to help food ingredient and dietary supplement companies gain FDA approval of new ingredients added to food or food supplements."
Dr. Flamm brings to AAC more than 43 years of academic, government and consulting experience. He is an internationally recognized expert and has been a Fellow in the Academy of Toxicological Sciences since 1999. Since retiring from the FDA in 1988 where he was the Director of Toxicological Sciences, Dr. Flamm has been providing consulting assistance to the regulated industry. During his 20-year government career, he held various positions in the National Institutes of Health, National Cancer Institute and the FDA. Dr. Flamm earned his Ph.D. from the University of Cincinnati.
Dr. Barnett offers 21 years of industry toxicology experience working for the Gulf South Research Institute, Monsanto Company, and Radian Corporation. Most recently he was a consulting toxicologist in private practice. He has been a Diplomate of the American Board of Toxicology since 1985. He earned his Ph.D. from the University of Texas Medical Branch.
The additions of Dr. Flamm and Dr. Barnett also complement the newly established pre-clinical safety services now offered by Kendle. Kendle offers its customers consultation in toxicology including preparation of risk assessments and design of pre-clinical safety programs. In addition, Kendle
can manage the conduct of safety programs at qualified testing laboratories and provide an integrated summary of the results for government submissions.
About Kendle International Inc.
Kendle International is a global provider of quality clinical research and development services for the pharmaceutical and biotechnology industries. Headquartered in Cincinnati, Ohio, Kendle is among the world's largest publicly held clinical research organizations, with approximately 1,700
associates worldwide. The company has conducted clinical trials or provided regulatory and validation services in 60 countries. Investor kits are available upon request from Kendle International Inc., 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202 or from the company's Web site at http://www.kendle.com .
About AAC Consulting Group
Based in Rockville, Md., AAC Consulting Group is a global provider of regulatory compliance, validation, training and information services to the pharmaceutical, biotechnology, medical device, food, dietary supplement and cosmetic industries. AAC works with customers in all areas of regulated
industry, and has relationships with regulatory authorities worldwide, including the FDA, the Medicines Control Agency (MCA) in the United Kingdom, the Pharmaceutical Inspection Convention (PIC) headquartered in Switzerland and other international agencies. AAC was founded in 1960 and is a subsidiary of Kendle International Inc. For more information about AAC Consulting Group
visit the AAC web site at http://www.aacgroup.com .