Laura Salazar-fontana PhD

Laura Salazar-Fontana began her regulatory affairs career in 2009 as an Immunogenicity Program Coordinator and immunogenicity expert at the FDA, while holding a Chemistry, Manufacturing and Controls (CMC) reviewer position. She evaluated the CMC and immunogenicity of multiple therapeutic proteins INDs, license applications (BLAs), and post-approval supplements. She was responsible for the review and Advisory Committee presentation of the immunogenicity of metreleptin (MYALEPT®), currently approved for the treatment of pediatric and adult lipodystrophy.

After 5 years at the FDA, Laura moved to the private sector to broaden her clinical development knowledge acting as an Immunology and Biomarkers expert for Sanofi-Genzyme. In this role, she provided strategic support for analytical bioassay development and immunogenicity risk assessment for Enzyme Replacement Therapies (Avalglucosidase alfa – Pompe’s disease), monoclonal antibodies (Sarilumab – KEVZARA® – Rheumatoid Arthritis, and Alirocumab – PRALUENT® - familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease), and gene therapies (Leber’s Congenital Amaurosis), while developing an expertise in biomarker qualification.

Laura then consolidated her CMC expertise by acting as the regulatory lead for several US and EU regulatory submissions for Sanofi-Genzyme (PRALUENT®), Fresenius Kabi SwissBiosim (Biosimilars), ZioPharm Oncology (autologous CAR-T cell and gene therapies), PokeACell (autologous tumor-infiltrating lymphocytes, TILs) and cBio (cell therapy manufacturing). Laura holds a PhD in Biochemistry and Molecular Biology and has authored various publications in multiple peer-reviewed journals. She is now based in Lausanne, Switzerland, where she works as an independent regulatory consultant.