Healthcare Industry News: sanofi-aventis
News Release - May 24, 2010
Cleveland BioLabs Adds Regulatory Affairs Expertise to Development TeamBUFFALO, NY--(HSMN NewsFeed) - Cleveland BioLabs, Inc. (NASDAQ:CBLI ) today announced that the Company has added two regulatory affairs executives to its development team. Donald Handley has been appointed Director of Regulatory Affairs, and Ann Hards, Ph.D., has been appointed Vice President of Regulatory Affairs. Handley will be responsible for development and ongoing implementation of the Company's regulatory strategy and interactions with the U.S. Food and Drug Administration (FDA) and other regulatory agencies and Hards will provide strategic oversight of these activities on a consulting basis.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, "We are very pleased to have the support of these two highly qualified regulatory experts with track records of success in drug development, as we advance CBLB502 towards submission for FDA licensure for Acute Radiation Syndrome and prepare to start clinical development of CBLB502 and other compounds for medical applications. Don and Ann are terrific additions to our development team."
Prior to joining CBLI, Handley was Director of Global Regulatory Affairs at Bausch & Lomb, Inc., where he directed submissions of several New Drug Applications and Investigational New Drug Applications, led preparation efforts for a successful FDA advisory committee meeting and multiple other FDA interactions and was involved in meetings with international regulatory authorities. From 1999 to 2002, Handley held the positions of Manager and then Senior Manager of Regulatory Affairs at Celltech / Medeva Pharmaceuticals Inc. From 1996 to 1999, he served as Senior Regulatory Affairs Associate and then Manager of Worldwide Regulatory Affairs at Bristol-Myers Squibb Company. Before this, he held several positions in Regulatory Affairs at Fisons Pharmaceuticals. Handley holds a Bachelor of Science in Biochemical Pharmacology from the State University of New York at Buffalo, a Master of Science in Natural Sciences from the Roswell Park Cancer Institute Graduate Division of the State University of New York at Buffalo and a Master of Business Administration from the State University of New York at Buffalo.
In addition to her role with CBLI, Dr. Hards is currently President of Pharmaceutical Development at Bridging Health-Matters, a consulting firm serving both small and large biopharmaceutical clients. Prior to founding the consulting firm, she was Executive Vice President of Regulatory Affairs at ARCA Biopharma with responsibility for all aspects of health authority interactions and regulatory strategy as well as management of the entire regulatory preparation process and staff. From 1996 to 2006, Hards held several regulatory and clinical development positions at sanofi-aventis including Vice President of Clinical Investigation Realization and Vice President of Worldwide Cardiovascular and Thrombosis Regulatory Affairs. Prior to this, she served as Associate Director of Regulatory Affairs at Somatix Therapy Corporation and as Manager of Regulatory Affairs, including US Agent for the Establishment License Application, at Pharmacia Inc. From 1990 to 1994, Hards was with the Parke-Davis Pharmaceutical Research Division of Warner-Lambert where she held several positions in Regulatory Affairs and Clinical Communications. Dr. Hards holds a Bachelor of Science in Agriculture from Purdue University and a Ph.D. in Biophysics and Genetics from the University of Colorado Health Sciences Center.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2009.
Source: Cleveland BioLabs
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