Executive Vice President Regulatory Affairs
Dr. Hards joined Cleveland BioLabs in 2010. Prior to this, she was the President of Pharmaceutical Development at Bridging Health-Matters, a consulting firm serving both small and large biopharmaceutical clients. Before 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, Dr. 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, Dr. 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 degree in Agriculture from Purdue University and a Ph.D. in Biophysics and Genetics from the University of Colorado Health Sciences Center.