Laura joined NDA in 2020 as part of the Translational Sciences team. She is experienced in US regulations and has helped several small and large companies define their Chemistry, Manufacturing and Controls (CMC), Immunogenicity, and Proof-of-Concept strategies to facilitate the successful filing of regulatory submissions at different stages of product development. She is a specialist in a broad range of biologics, including biosimilars, and Advanced Therapeutic Medicinal Products (ATMP).
Laura is a member of Immunogenicity Integrated, this is a platform created by three members of the NDA Advisory Board, who combine extensive multi-disciplinary experience of assessing immunogenicity for different biotherapeutic modalities, including ATMPs. Deeper understanding of intrinsic and extrinsic factors that may influence immunogenicity enables de-risking of the product development process in a manner that is fully aligned with regulatory expectations. NDA group and Immunogenicity Integrated work in close partnership to provide documentation, including risk assessment for Clinical Trial Applications and Scientific Advice meetings, and the Integrated Summary of Immunogenicity for global registration dossiers.
Key Areas Of Expertise
- Extensive expertise in the US regulatory space:
- Defining the CMC regulatory strategy for INDs, BLA applications, and post-marketing supplements
- Preparing all sections of Module 3 of the eCTD dossier (CMC) of therapeutic proteins, including biosimilars, and Advanced Therapies (gene and cell therapies)
- Immunogenicity Risk Assessment and bioanalysis for Biologics, Biosimilars and Advanced Therapies (gene and cell therapies)
- Biomarker selection and qualification to support Proof-Of-Concept studies
- Professional presentation skills, including FDA Advisory Committee meetings, and teaching experience
Before Joining The NDA Advisory Board
Laura acted as Immunogenicity Program Coordinator and immunogenicity expert at the FDA, while holding a CMC reviewer position, before progressing to the private sector.
She first broadened her clinical development expertise acting as Immunology and Biomarkers expert for Sanofi-Genzyme, and, later consolidated her expertise in CMC acting as the regulatory lead for the preparation of US and EU regulatory submissions at different stages of product development for Sanofi-Genzyme, ZioPharm Oncology, Fresenius-Kabi SwissBiosim, PokeACell and cBio.
Laura holds a PhD in Biochemistry and Molecular Biology and spent over 14 years studying the molecular mechanisms of antigen recognition before becoming a regulatory affairs advisor. She has authored various publications about the molecular mechanisms of antigen recognition and immunogenicity of therapeutic proteins in multiple peer-reviewed journals.
Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A. Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development. AAPS Journal 2017; 19(2):377-385.
Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS Journal, 2016, 18(2): 311-20.
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L. et al. White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity), Bioanalysis, 2015; 7 (24)
Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F et al. White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity), Bioanalysis, 2014; 6 (24)
Immunogenicity reviewer (DS) of MYALEPT. Responsible for the FDA presentation of the Immunogenicity risk assessment, analytical evaluation and clinical data at Advisory Committee held on December 2013.
Preparation of the FDA Guidance for Industry – Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Anti-Drug Antibody Detection –https://www.fda.gov/media/119788/download
Dr Laura Inés Salazar-Fontana