Principal
LAIZ Regulatory Science Consulting
Lausanne, Vaud, Switzerland
Dr. Salazar-Fontana is a principal consultant at NDA Partners and LAIZ Reg Science especialized in the field of immunogenicity. She has been in the field, first as an immunogenicity expert and CMC reviewer within the Division of Therapeutic Proteins (CDER, FDA), and also as Translational Science lead for Immunology and Biomarkers (Sanofi) and CMC Regulatory affairs lead for biosimilars (Fresenius Kabi SwissBiosim GmbH) and cell and gene therapy products (ZioPharm Oncology).
Dr. Salazar-Fontana holds a PhD in Biochemistry and Molecular Biology and spent over 15 years as immunology post-doctoral fellow at the National Institutes Health (NIH, USA) and as assistant professor at the George Washington University (GWU, USA) before joining FDA.
She is the co-founder of the Immunogenicity Integrated (I&I) platform, member of the Immune Responses Therapy committee in the American Society of Gene & Cell Therapy (ASGCT), and member of the American Society of Pharmaceutical Scientists (AAPS).
Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century Modalities
Monday, October 23, 2023
9:00 AM – 10:00 AM ET