Kirsten E Coleman

Kirsten Coleman is the Assistant Director of the Toxicology Core at the University of Florida’s Powell Gene Therapy Center, bringing 20 years of expertise in translational research with a focus on gene therapy for rare diseases. She began her career in Dr. Terence Flotte’s laboratory at UF, where she completed her honors thesis in 2004 on the development of AAV gene therapy for methylmalonic acidemia. Following this, she joined the newly established Toxicology Core, where she played a key role in conducting pivotal nonclinical studies that contributed to the first human trial of an AAV gene therapy vector for treating alpha-1 antitrypsin deficiency. Throughout her career, Kirsten has been deeply involved in the translational development of AAV gene therapies for various rare diseases. Her current research centers on the nonclinical and clinical evaluation of cell and gene therapy candidates, with a focus on assessing biodistribution, immunogenicity, pathology, and efficacy. She has contributed to over a dozen FDA-cleared Investigational New Drug (IND) applications for neuromuscular, metabolic, retinal, and neurological disorders, as well as two FDA-licensed AAV gene therapies. Kirsten earned both her M.B.A. and B.S. from the University of Florida, and her work continues to shape the future of gene therapy for rare diseases.