Mark A. De Rosch, PhD, FRAPS, Senior Vice President, Regulatory Affairs and Quality Assurance at Nightstar Therapeutics. He was formerly Senior Vice President of Regulatory Affairs, Quality Assurance, and CMC at Akebia Therapeutics, Inc. Prior to Akebia, Dr. De Rosch was Vice President, Regulatory Drugs/Biologics & Head, U.S. Operations for Voisin Consulting Life Sciences, where he served as the organization’s lead U.S. Food & Drug Administration (FDA) regulatory expert. Previously, Dr. De Rosch served as Vice President, Head of Global Regulatory Affairs for Inspiration Biopharmaceuticals, Inc., leading the development and implementation of global regulatory strategies for the hemophilia-focused company. He also served in multiple key roles at Vertex Pharmaceuticals, Inc., including Senior Director, Global Clinical Regulatory Strategy, where he led the regulatory strategy and submissions process for Kalydeco® in cystic fibrosis leading to rapid approvals in the U.S. and E.U. Dr. De Rosch has over two decades of experience guiding global regulatory strategies for clinical, nonclinical and chemistry, manufacturing and controls (CMC) in multiple therapeutic areas including renal, hemophilia, autoimmune, pulmonary and oncology/hematology.