Mike has been a CMC Reviewer in the Gene Therapy Branch since 2004. Gene Therapies are a diverse group of new technologies that include genetically modified viruses and cells. Mike’s recent accomplishments include serving as BLA Chair for a genetically modified autologous T-cell immunotherapy and championing the release of new Gene Therapy guidance documents. Prior to joining FDA, Mike received a Ph.D from the University of Wisconsin and conducted postdoctoral fellowships at JHU and NIH.