SPEAKER BIOGRAPHIES:
Andrew Byrnes, PhD, Chief, Gene Transfer and Immunogenicity Branch, CBER, FDA
Andrew P. Byrnes, PhD, is Chief of the Gene Transfer and Immunogenicity Branch, which is in the Division of Cellular and Gene Therapies at FDA’s Center for Biologics Evaluation and Research. He has over 20 years of experience at FDA in reviewing the manufacturing of gene therapies, cell therapies and other products for clinical use. The Gene Transfer and Immunogenicity branch is a group of six laboratories that perform research to improve the safety and efficacy of cell and gene therapies, and members of the Branch also review manufacturing of investigational and licensed cell and gene therapy products. Dr. Byrnes has a background in virology and gene therapy. Dr. Byrnes received his undergraduate degree from Yale University, earned his Ph.D. from the University of Oxford, and then conducted postdoctoral research at Johns Hopkins University before joining FDA in 2000.
Kristina E. Howard, PhD, Staff Fellow, Division of Drug Safety Research, FDA
No bio available
Wojciech Jankowski, PhD, Commissioner’s Fellow, CBER, FDA
Dr. Jankowski is a research reviewer
with the US Food and Drug Administration in the Office of Tissues and Advanced Therapies. He is part of an active research laboratory and his research interests lie in the regulatory-science associated with the licensure of the next generation of
therapeutic proteins. A key focus of his research activities has been to understand the immune response to protein therapeutics, which can significantly affect the efficacy and safety of these drugs. He uses a combination of computational, in vitro
and ex vivo approaches in his work. Dr. Jankowski received his Ph.D. from Rutgers University, NJ and was subsequently selected for the highly competitive Commissioner’s Fellowship program at the FDA. His research has been published in high impact
journals such as Nature and Nature Chemical Biology.
Daniel LaGasse, PhD, Research Regulator, CBER, FDA
Daniel Lagassé conducts research and CMC review as a Biologist in the Division of Plasma Protein Therapeutics within the Center of Biologics Evaluation and
Research at the U.S. Food and Drug Administration. Dr. Lagassé received his PhD in Molecular Microbiology and Immunology from Johns Hopkins Bloomberg School of Public Health.
Ronit Mazor, PhD, Principal Investigator, CBER, FDA
Ronit Mazor did her undergraduate studies in Tel Aviv University in Israel. She performed her PhD in the NIH’s International Graduate Partnership Program,
in collaboration with Tel Aviv University. Ronit continued her Post doctoral training in the national cancel institute working on the immunogenicity of recombinant immunotoxins for cancer therapy with Ira Pastan. She then joined the antibody discovery
and protein engineering in Medimmune/AstraZeneca in Gaithersburg where she established their cellular and in silico pre-clinical immunogenicity prediction platform. In 2019, Ronit joined the Gene Transfer and Immunogenicity Branch in the FDA as a
principal investigator. She is leading a research group studying the interaction between the immune system and gene therapy viral vectors.
Zuben Sauna, PhD, Research Biologist, CBER, FDA
Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the
immune response to proteins used in therapeutic interventions as these affect efficacy and safety. His laboratory exploits a combination of computational, in vitro and ex vivo approaches to understand why some individuals and/or sub-populations develop
immune responses while others do not. Work from his laboratory has been published in high impact journals such as Nature Biotechnology, Nature Medicine, Science, Science Translational Medicine and Nature Reviews Genetics. He received his Ph.D. from
Poona University, India with subsequent training at the National Cancer Institute, Bethesda, USA.
Daniela Verthelyi, MD, PhD, Chief, Laboratory of Immunology, CDER, FDA
Dr. Verthelyi directs a lab focused on understanding innate immunity and inflammation and applying the information to address regulatory problems. Her group develops
new methods and models to understand the role of product and process related impurities on product immunogenicity, as well as animal models to assess the safety and efficacy of innate immune response modulators and other therapeutics to respond to
infectious diseases. Dr. Verthelyi trained in medicine at the University of Buenos Aires and then obtained a PhD in Immunology from Virginia Tech in USA. She has authored over 100 peer-reviewed articles, is the inventor in several patents, and has
received FDA's, CBER’s, and CDER’s “Excellence in Laboratory Sciences” awards, among other honors. In addition to her position at FDA, she has Chaired the FDA-NIH Immunology Interest Group, the NIH-FDA Cytokine Interest Group,
and served on the Advisory Boards for the NIH Human Immunology Group.