🎓 Inno4Vac Ethics Workshop: Refining the regulatory context of Controlled Human Infection Models (CHIMs)

Today, experts from academia, industry, regulatory agencies, and ethics committees gathered in Leiden, The Netherlands, for a dedicated workshop on the ethical and regulatory landscape of Controlled Human Infection Models (CHIMs) within the framework of the Inno4Vac project.

🧩 Organized by Work Package 11, led by Dr Pieter Neels (IABS-EU), this one-day workshop explored the complex balance between innovation, ethics, and regulation in advancing vaccine development using CHIMs for RSV, C. difficile, and influenza.

Key discussions revolved around:
1️⃣ Refining the regulatory framework for CHIM-related challenges (CMC, tox, GMO…).
2️⃣ Evaluating the ethical justification for CHIM trials within evolving European regulations.
3️⃣ Understanding the potential of CHIMs to accelerate vaccine development by providing early proof-of-concept data.

💡 With insightful contributions from international experts such as Anna Durbin (Johns Hopkins University), @Seema Shah (Lurie Children’s Hospital of Chicago), and representatives from GSK, Sanofi, Leiden University Medical Center, and Utrecht University, this event provided a platform for constructive dialogue on the responsible integration of CHIMs into the vaccine development pipeline.

#Inno4Vac #EUfunded #VaccineDevelopment #Ethics #Regulation #CHIM #ClinicalResearch #IABS #InnovativeHealthInitiative #Horizon2020

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This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799 (Inno4Vac). 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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