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Dr. Hayes has more than 25 years of experience in research and development of innovative therapeutics for rare diseases and cancer. Through 2015, he was Senior Vice President of Regulatory Affairs and Pharmacovigilance at Synageva Biopharma prior to their acquisition by Alexion Pharmaceuticals, where he led efforts to support the approval of Kanuma for lysosomal acid lipase deficiency, and provided strategic regulatory leadership for additional rare disease pipeline products. Prior to Synageva, Dr. Hayes was Group Vice President of Regulatory Affairs at Genzyme, where over 11 years he led the regulatory function for oncology and biosurgery as well as CMC regulatory organization for all therapies. Prior to joining industry, Dr. Hayes served at FDA for over 9 years at the Center for Biologics Evaluation and Research, where he conducted independent research in cytokine biology and managed the review of numerous recombinant proteins. Dr. Hayes received a B.S. from Davidson College and holds a Ph.D. in immunology and experimental pathology from the University of Florida.