Vice President, Regulatory Affairs & Quality
Eugene Helsel brings more than 27 years of experience in the biotech industry with 20 years of experience in regulatory affairs and quality. His regulatory and quality experience has been focused on GMP compliance, chemistry, manufacturing, and controls (CMC), and preclinical studies specific to cellular and viral vector-based gene therapies. Prior to joining Artiva, Mr. Helsel served as a principal consultant in cell therapy for the Halloran Consulting group. Prior to Halloran he was the Senior Director of Regulatory Affairs at Capricor focusing on developmental cardiomyocyte based cellular therapies. Prior to that, he was the Executive Director of Regulatory Affairs and Quality at Fate Therapeutics focused on hematopoietic stem cell-based therapies and induced pluripotent stem cell derived therapies. Mr. Helsel holds Regulatory Affairs and Quality Assurance certificates from UC San Diego. He earned a B.A. in psychology from UC San Diego and a B.S. in manufacturing engineering from National University.