The third Inno4Vac Subtopic 3 (MERMAID) Regulatory stakeholder meeting- “A regulatory exchange on characterization and qualification of 3D mucosal models for vaccine development” was held June 6th and hosted by the Dutch National Institute for Public Health and the Environment (RIVM) in Bilthoven (Utrecht), the Netherlands.
June 6th
The 1-day meeting brought together over 50 people from 28 organisations, including Inno4Vac academic and industry partners, model developers with expertise in tissue structure and immunology, vaccine regulators from various agencies across Europe and members of industry and other consortiums with expertise in this field.
The goal of Subtopic3 is to develop cell-based in vitro 3D models able to accurately depict the in vivo conditions during mucosal infection and reliably predict mucosal immune protection so that we have a tool to help evaluate vaccine candidates or therapies in preclinical and clinical studies. The meeting fostered discussion between regulators, academics, and industry as a means to reach a common understanding of the challenges and advantages of using such models in vaccine research.
During the meeting, there were discussions on topics such as: designing a qualification framework for complex in vitro models, choosing acceptance criteria for model readouts and characteristics, and making a model relevant for its intended use occurred. Examples from other models/initiatives were shared by external experts, including an overview of practical findings from the recent EMA MPS (Microphysiological Systems) workshop; a case study by VisMederi on successful model qualification of an influenza assay; and presentations on how toxicology models can teach us about building relevant systems, and what the ImmuneChip+ program can teach us about modelling a well-characterized system. The end of the workshop focussed on future needs and considerations of the MERMAID sub-topic for the remainder of the Inno4Vac project and covered building a common understanding of regulatory terms, goals, and needs; discussing the new EMA guidance document; and starting our pre-clinical positioning and how to replace animal data in an application dossier. Specific qualification gaps needing to be addressed for our specific models was discussed during our expert round table based on standard operating procedures (SOPs) produced by each work package.
This workshop is one of several that will contribute to our regulatory roadmap – a publicly available document on how to transition 3D in vitro tissue culture models from academia to use in non-clinical and clinical vaccine development studies and gain regulatory approval.
Discover more on the MERMAID Subtopic 3 goals here: https://www.inno4vac.eu/st3mermaid.
Read workshop reports here: https://www.inno4vac.eu/public-deliverables-and-reports
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
This communication reflects the authors' view(s) and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
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