Michael Havert

Mike started as a Senior Director of Regulatory CMC at bluebird bio in February 2019. Before coming to bluebird, Mike worked in the FDA Gene Therapy Branch (GTB) for 15 years. Mike has long been interested in studying viruses, and this interest fit well with the diverse group of technologies that have historically been used in gene therapy applications. As CMC Reviewer in GTB he assessed how products were made and tested, the science supporting their development and use in clinical studies, and potential impacts on patient safety and environmental exposure. Mike’s recent accomplishments at FDA include serving as BLA Review Chair for one of the three GTB BLA approvals in 2017, championing the release of new GT guidance documents and representing FDA in efforts to harmonize global GT regulation. Prior to joining FDA, Mike received a Ph.D. from the University of Wisconsin, conducted postdoctoral fellowships in virology at JHU (Sindbis virus) and NIH (HBV/HCV) and taught biology at a local Community College in Virginia.