Donald J. Handley, MSc, MBA Don Handley’s career in regulatory affairs spans over 20 years in the pharmaceutical industry. From 2002 through May 2010, he was Director of Global Regulatory Affairs at Bausch & Lomb Incorporated, where he oversaw regulatory aspects in the development of new ophthalmic prescription, generic, and over-the-counter medicines as well as dietary supplements. His main responsibilities included liaising with health authorities, developing regulatory strategies for the global development and registration of pharmaceuticals, and submitting investigational and marketing applications. Prior to Bausch & Lomb, Don worked in regulatory affairs for Celltech and Medeva Pharmaceuticals, Bristol-Myers Squibb, and Fisons Pharmaceuticals, covering neuropharmacological, dermatological, respiratory and cardiovascular therapeutic areas. In May 2010 he joined Cleveland BioLabs as Director Regulatory Affairs responsible for development and implementation of the Company’s regulatory strategy and interactions with the FDA, for which he is currently working on a consulting basis. In August 2010 he joined Roswell Park Cancer Institute as Administrative Director, Research Subject Protection and Scientific Integrity, responsible for overseeing regulatory aspects of the human and animal research programs, and the functioning of the Institutional Review Board and Institutional Biosafety and Animal Care and Use Committees. Don holds a Bachelor of Science degree in Biochemical Pharmacology, a Master of Science degree in Natural Sciences, which included concentrations in immunology and oncology, and a Master of Business Administration, all from the State University of New York at Buffalo.