I am a basic research scientist specialized in regulatory science/affairs with over 15 years of experience in immunogenicity and chemistry, manufacturing, and controls (CMC) aspects of biotherapeutics development. I acquired my regulatory experience as FDA quality and immunogenicity reviewer at the Center of Drug Evaluation and Research (CDER). My dynamic nature propelled me to move into the developers side, first as translational sciences lead within the Genzyme-Sanofi clinical testing laboratory group, and later on as CMC regulatory affairs director responsible for defining the strategy, content, and timelines for FDA and EMA regulatory submissions for biotherapeutics, including cell and gene therapy, peptides, oligonucleotides, and biosimilar products.

Prior to joining the FDA, I spent over 14 years as scientist in the fields of biochemistry, molecular biology, and immunology. First as a doctoral student at the Autónoma University of Madrid (UAM, Spain), where I obtained my PhD, before pursuing a post-doctoral fellowship at the National Institutes of Health, (NIH, USA) completed by two years as post-doc/assistant professor at the Center for Cancer and Immunology Research, Children’s National Medical Center, part of Georgetown University School of Medicine (GWU, USA).

As of 2020, I have been consulting for biotechnology and pharma companies, directly through my Swiss-based company, LAIZ Regulatory Science Consulting SARL, and as cofounder of the Immunogenicity Integrated platform side-by-side Paul Chamberlain.