Dr. Alex Kuta joined uniQure in January 2017 as Senior Vice President, Regulatory Affairs. In his current role as Executive Vice President, Operations, he is responsible for global quality and regulatory affairs, as well as GMP manufacturing at uniQure’s state-of-the-art facility in Lexington, Massachusetts.
He joined uniQure from EMD Serono, where he served as Vice President of Research & Development Global Regulatory Affairs and where he was a member of the U.S. Leadership Team. In this role, he was responsible for driving the strategic direction of EMD Serono’s regulatory efforts in immune-mediated diseases, oncology and regulatory CMC, as well as strengthening interactions with the U.S. Food and Drug Administration (FDA).
Prior to joining EMD Serono, Dr. Kuta was Vice President of Global Regulatory Affairs and a member of the Executive Leadership Team at Lantheus Medical Imaging. His previous experience includes senior roles at AMAG Pharmaceuticals and at Genzyme Corporation, where he served for 15 years in regulatory leadership positions of increasing responsibility. Prior to joining industry, he was Chief of the Cytokine and Gene Therapy Branch in the Center for Biologics at FDA. Dr. Kuta has also served as a member of the BIO Regulatory Affairs Leadership Committee, Cell and Gene Therapy Working Group and the ICH Gene Therapy Working Group.
Dr. Kuta holds a Bachelor of Science degree from Saint John's University and a Ph.D. from Chicago Medical School at Rosalind Franklin U-Med & Science. He conducted his post-doctoral studies at the National Cancer Institute/ National Institutes of Health.