RRI: lessons learned from EUNCL … · RRI Questions /1 •Involve stakeholders of relevance to the...
Transcript of RRI: lessons learned from EUNCL … · RRI Questions /1 •Involve stakeholders of relevance to the...
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RRI: lessons learned fromEUNCL
Patrick Boisseau, coordinator
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EUNCL is the
European Research Infrastructure
for the preclinical
Characterisation of Nanomedicines
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The mission
• Perform pre-clinical characterization of nanomedicines
• Identify and characterize critical parameter of nanomaterial in biological systems
• Develop improved analytical methods
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Partners
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Concept
Regulators(EMA, FDA, National Agencies)
CONFIDENTIAL 55/22/2019
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Innovation chain in nanomedicine
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EUNCL offer
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Application to EUNCL
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Applications’ origineFrance
Germany
UK
Poland
Italy
Spain
Swizerland
Netherlands
Israel
DenmarkGrece Ireland
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Targeted diseases
Cancer
Alzheimer
Other
Passive targeting
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Type of nanomaterials
Liposome
Dendrimer
Metalic NP
Polymer
Protein
Micelle
Oxyde
SilicaNP
Virosome
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Lessons learned
• Role of EUNCL evolves– Characterisation support– Help prepare better application
• Maturity of sponsors and compounds– Advanced vs. Early stage– Difficulties in delivering GMP-like batches
• Each case is unique– Material– Targeted applications– Clinical complexity– Customised Characterisation
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Interface with regulators
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RRI Questions /1
• Involve stakeholders of relevance to the project (e.g. clinicians, patient interest groups) at the earliest possible stage
• Involve all partners and participants in ongoing consideration of RRI throughout the project period
• Reflect on/consider adapting your choice of research methods and goals (including ethical issues)
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RRI Questions /2
• Address environmental impacts and sustainable solutions
• Show how the project (and product) satisfy requirements for production safety and efficiency
• Ensure that the medicine or device in the body is a safe product with clear benefits for the patient