Alisha Bouge, MS, RAC
Senior Director, Regulatory Affairs
Alisha Bouge is the Senior Director, Regulatory Affairs at Exegenesis Bio, with rich experience in gene therapy products regulatory filling.
Before joining Exegenesis Bio, Alisha worked for Stanford University as the Director for Regulatory Affairs and Quality Assurance for their Stem Cell Transplant & Gene Therapy Clinical Trials Program (CTP) since Oct 2016. During her six years at Stanford University, she successfully submitted over 5 INDs in Cell & Gene Therapies, built in-house RA submission capabilities, grew the team in size, and got promoted four times. Before that, she was IRB Manager for Quorum Review and IRBMED Assistant Director for the University of Michigan, which focused on Independent Review Board (IRB) review work.
Alisha worked as Project Manager of Clinical Advisory Panels (CAPs) for the California Institute for Regenerative Medicine (CIRM) from 2015-2016 and in various roles for Stanford University from 2011-2015.
Alisha has a Master's degree in Biomedical Regulatory Affairs and a Bachelor's degree in English Literature, both from the University of Washington. She holds Regulatory Affairs Certification-US (RAC) and is a Certified IRB Professional (CIP).