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As VP and Head of Regulatory Affairs, Kevin is responsible for understanding, developing, and managing the Regulatory Affairs strategy for WEP’s Expanded Access Programs (EAP), Compassionate Use Programs (CUP), and Named Patient Programs (NPP). Kevin has over 25 years of experience in the pre-approval/expanded access and clinical research space. In his previous role as the Managing Director of the Michigan Institute for Clinical & Health Research (MICHR) and Adjunct Associate Clinical Professor in the College of Pharmacy at the University of Michigan, Kevin was instrumental in the development of institutional policy and processes as they relate to FDA-regulated research.