Dr. Francissen has been dedicated to the development of gene therapy products over the past few years, thus leveraging over twenty years of experience in the biopharmaceutical industry. As the CMC regulatory lead for an individualized neoantigen-specific immunotherapy (iNeST) program, she is developing a novel regulatory framework in which the neoepitope selection process is an integral part of production. Kathleen has served on several conference planning committees, and was involved in establishing the Casss Cell & Gene Therapy Products annual conference. She was a member of the CASSS Board of Directors for the 2015-2018 term. She joined Genentech in 1997 as a Scientist in Analytical Chemistry where she conducted proteomics studies of host cell proteins derived from mammalian and bacterial cells. Since then, she has held various roles, including Senior Scientist and then Director of Protein Analytical Chemistry. In addition to her functional leadership roles, she has led cross-functional teams. Prior to joining Genentech, Kathleen conducted postdoctoral studies at the U.S. Department of Energy and was a Visiting Scientist at the Max Planck Institute for Marine Microbiology in Germany.