Jakob Reiser

Jakob received his Ph.D. in Biochemistry from the University of Basel (Switzerland). He did postdoctoral work as an American Cancer Society Junior Fellow at the Department of Biochemistry, Stanford University School of Medicine. He then worked as a Research Fellow at the Imperial Cancer Research Fund Laboratories in London, UK. He was a group leader and lecturer in Biotechnology at ETH (Swiss Federal Institute of Technology) in Zürich, Switzerland between 1986 and 1994.

He joined the National Institutes of Health (NIH) in Bethesda in 1994 to gain experience in the emerging field of gene therapy. At NIH he worked on the design of HIV-1-based lentiviral vectors and was among the first to develop such vectors.

He then moved to the Louisiana State University (LSU) Health Sciences Center in New Orleans in 1999 as Associate Professor of Medicine and Director of the Gene Therapy Vector Core. At LSU he gained considerable experience applying lentiviral vectors in the context of in vitro, ex vivo and in vivo applications.

Jakob joined FDA/CBER in 2008 as a Principal Investigator to run a laboratory and to conduct regulatory work. His laboratory work at CBER/FDA focused on issues related to the safety and manufacture of lentiviral vectors. Jakob’s regulatory work at FDA/CBER involved reviewing Pre-IND, INTERACT and IND submissions. The majority of his INDs included both gamma retroviral and lentiviral vectors used in a variety of indications, particularly cancer. He also engaged in informal consultations within the FDA and with sponsors. He was involved in numerous Regulatory Policy Activities and he gave Regulatory Presentations both at FDA and at Scientific Meetings, including ASGCT.

He participated in the review of multiple CAR T-cell BLAs involving gamma retroviral vectors and lentiviral vectors. He chaired the BLA for ZYNTEGLO (betibeglogene autotemcel), an autologous hematopoietic stem cell-based gene therapy for β-thalassemia.  The ZYNTEGLO BLA was approved by FDA in August of 2022.