Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals
Biologics have revolutionized disease management in many therapeutic areas by addressing unmet medical needs and overcoming resistance to standard-of-care treatment in numerous patients. However, the development of unwanted immune responses directed against these drugs, humoral and/or cellular, can...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2024.2324801 |
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| author | Sophie Tourdot Daniel Baltrunkonis Sofie Denies Viswanath Devanarayan Joanna Grudzinska-Goebel Arno Kromminga Gregor P. Lotz Laurent Malherbe Lydia Michaut Karin N. Weldingh Joao A. Pedras-Vasconcelos Laura. I. Salazar-Fontana Sebastian Spindeldreher Zuben Sauna Veerle Snoeck Daniela Verthelyi Daniel Kramer |
| author_facet | Sophie Tourdot Daniel Baltrunkonis Sofie Denies Viswanath Devanarayan Joanna Grudzinska-Goebel Arno Kromminga Gregor P. Lotz Laurent Malherbe Lydia Michaut Karin N. Weldingh Joao A. Pedras-Vasconcelos Laura. I. Salazar-Fontana Sebastian Spindeldreher Zuben Sauna Veerle Snoeck Daniela Verthelyi Daniel Kramer |
| author_sort | Sophie Tourdot |
| collection | DOAJ |
| description | Biologics have revolutionized disease management in many therapeutic areas by addressing unmet medical needs and overcoming resistance to standard-of-care treatment in numerous patients. However, the development of unwanted immune responses directed against these drugs, humoral and/or cellular, can hinder their efficacy and have safety consequences with various degrees of severity. Health authorities ask that a thorough immunogenicity risk assessment be conducted during drug development to incorporate an appropriate monitoring and mitigation plan in clinical studies. With the rapid diversification and complexification of biologics, which today include modalities such as multi-domain antibodies, cell-based products, AAV delivery vectors, and nucleic acids, developers are faced with the challenge of establishing a risk assessment strategy sometimes in the absence of specific regulatory guidelines. The European Immunogenicity Platform (EIP) Open Symposium on Immunogenicity of Biopharmaceuticals and its one-day training course gives experts and newcomers across academia, industry, and regulatory agencies an opportunity to share experience and knowledge to overcome these challenges. Here, we report the discussions that took place at the EIP’s 14th Symposium, held in April 2023. The topics covered included immunogenicity monitoring and clinical relevance, non-clinical immunogenicity risk assessment, regulatory aspects of immunogenicity assessment and reporting, and the challenges associated with new modalities, which were discussed in a dedicated session. |
| format | Article |
| id | doaj-art-3bd88e5978b34872b17ec5165f9aa0d5 |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj-art-3bd88e5978b34872b17ec5165f9aa0d52025-01-31T04:19:38ZengTaylor & Francis GroupmAbs1942-08621942-08702024-12-0116110.1080/19420862.2024.2324801Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticalsSophie Tourdot0Daniel Baltrunkonis1Sofie Denies2Viswanath Devanarayan3Joanna Grudzinska-Goebel4Arno Kromminga5Gregor P. Lotz6Laurent Malherbe7Lydia Michaut8Karin N. Weldingh9Joao A. Pedras-Vasconcelos10Laura. I. Salazar-Fontana11Sebastian Spindeldreher12Zuben Sauna13Veerle Snoeck14Daniela Verthelyi15Daniel Kramer16Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc, Andover, MA, USAResearch and Development, Clinical Pharmacology and Bioanalytics, Clinical Bioanalytics, Groton, CT, USASD Analytics, Bellem, BelgiumEisai Inc, Nutley, NJ, USADMPK Project Management, Pharmaceuticals R&D, Bayer AG, Berlin, GermanyBioNTech SE, Mainz, GermanyRoche Pharma Research and Early Development (pRED), Roche Innovation Center Munich, Hoffmann-La Roche Ltd, Penzberg, GermanyLilly Research Laboratories, a Division of Eli Lilly and Company, Indianapolis, IN, USANovartis Biomedical research, PK Sciences, Basel, SwitzerlandDepartment of Clinical Immunogenicity Analysis, Novo Nordisk A/S, Maaloev, DenmarkDivision of Biotech Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USALAIZ Regulatory Science, Lausanne, SwitzerlandIntegrated Biologix GmbH, Basel, SwitzerlandDivision of hemostasis, Office of Plasma Protein Therapeutics; Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USATranslational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l’Alleud, BelgiumDivision of Biologics Research and Review III; Ofrfice of Biotechnology Products; Center for Drug Evaluation and Research; Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, MD, USAGlobal Scientific Advisor Immunogenicity, Translational Medicine & Early Development, Sanofi Aventis Deutschland GmbH, Frankfurt am Main, GermanyBiologics have revolutionized disease management in many therapeutic areas by addressing unmet medical needs and overcoming resistance to standard-of-care treatment in numerous patients. However, the development of unwanted immune responses directed against these drugs, humoral and/or cellular, can hinder their efficacy and have safety consequences with various degrees of severity. Health authorities ask that a thorough immunogenicity risk assessment be conducted during drug development to incorporate an appropriate monitoring and mitigation plan in clinical studies. With the rapid diversification and complexification of biologics, which today include modalities such as multi-domain antibodies, cell-based products, AAV delivery vectors, and nucleic acids, developers are faced with the challenge of establishing a risk assessment strategy sometimes in the absence of specific regulatory guidelines. The European Immunogenicity Platform (EIP) Open Symposium on Immunogenicity of Biopharmaceuticals and its one-day training course gives experts and newcomers across academia, industry, and regulatory agencies an opportunity to share experience and knowledge to overcome these challenges. Here, we report the discussions that took place at the EIP’s 14th Symposium, held in April 2023. The topics covered included immunogenicity monitoring and clinical relevance, non-clinical immunogenicity risk assessment, regulatory aspects of immunogenicity assessment and reporting, and the challenges associated with new modalities, which were discussed in a dedicated session.https://www.tandfonline.com/doi/10.1080/19420862.2024.2324801Anti-drug antibodyclinical relevanceimmunogenicityrisk assessment |
| spellingShingle | Sophie Tourdot Daniel Baltrunkonis Sofie Denies Viswanath Devanarayan Joanna Grudzinska-Goebel Arno Kromminga Gregor P. Lotz Laurent Malherbe Lydia Michaut Karin N. Weldingh Joao A. Pedras-Vasconcelos Laura. I. Salazar-Fontana Sebastian Spindeldreher Zuben Sauna Veerle Snoeck Daniela Verthelyi Daniel Kramer Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals mAbs Anti-drug antibody clinical relevance immunogenicity risk assessment |
| title | Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| title_full | Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| title_fullStr | Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| title_full_unstemmed | Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| title_short | Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| title_sort | proceedings of the 14th european immunogenicity platform open symposium on immunogenicity of biopharmaceuticals |
| topic | Anti-drug antibody clinical relevance immunogenicity risk assessment |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2024.2324801 |
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