Conference Presentations
2026
(Coming up)
17th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals, March 16th — 19th, 2026.
Presentation: “Aligning Regulatory Expectations on Immunogenicity to Support Peptide Drug Product Approvals”
17th Immunogenicity Bioassay & Summit, October 7-10, 2025. Immunogenicity of peptides session. Presentation: “Evaluating and Mitigating the Immunogenicity of Peptide Products during their Life Cycle”
2025
2023 AAPS PharmSci 360 Conference - Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century Modalities, Oct 23rd, 2023. Presentation: “Using the immunogenicity risk assessment approach to define the context of use”
2023
14th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals, Lisbon, April 26-28, 2023. Presentation: “Innate and adaptive immune responses to Gene Therapy Products”
2023
6845 APV Workshop on Protein aggregation and Immunogenicity, May 31- June 1st, 2022. Presentation: “Evaluating the immunogenicity of ATMP/CGT”
2022
3rd Annual Gene therapy Immunogenicity, October 18-20th, 2022. Presentation: “Applying an Immunogenicity Risk-Based Approach to Gene Therapy Products”
2022
13th Immunogenicity Summit – October 2021. Presentation: “Predicting and mitigating the immunogenicity of Cell & Gene therapies”
2021
Publications
Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? Laura I. Salazar-Fontana, Ph.D., and Daniela Drago, Ph.D., RAC, NDA Partners. BioProcess Online, Guest Column, May 21, 2024
2024
Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals. MAbs. 2024 Jan-Dec;16(1):2324801. Epub 2024 Mar 5. Tourdot S, Baltrunkonis D, Denies S, Devanarayan V, Grudzinska-Goebel J, Kromminga A, Lotz GP, Malherbe L, Michaut L, Weldingh KN, Pedras-Vasconcelos JA, Salazar-Fontana LI, Spindeldreher S, Sauna Z, Snoeck V, Verthelyi D, Kramer D.
2024
Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Companion Diagnostics. Lu, Y and Gorovitz, B. 2024-02-09, Wiley Professional, Reference & Trade. Available from: vbk://9781119852803. Current Regulatory Landscape for Gene Therapy Product Development Authors: Laura I. Salazar-Fontana, PhD and Michael Havert, PhD
2024
A regulatory risk-based approach to the development of ATMP/CGT: integrating scientific challenges with current regulatory expectations and pathways. Frontiers in Medicine, Research Topic : Global Excellence in Gene and Cell Therapy: Europe , 13 May 2022. Laura I. Salazar-Fontana, PhD
2022
Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development. AAPS Journal 2017; 19(2):377-385. Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A.
2017
Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS Journal, 2016, 18(2): 311-20. Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L.
2016
2015
2014