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European Infrastructure to improve translation in nanomedicine
Cupido workshop, Chilly-Mazarin
www.euncl.eu
Outline
• What is EUNCL
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• How does it work
• Where does it stands
ID
• Research Infrastructure funded under H2020– « Starting community »
• Grant agreement – #654190
• Funding period– May 2015-April 2019
• EC Grant– € 4,995,181.00
• 8 partners
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EUNCL in the Nanomed Translation Hub
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European Nanomedicine Characterization Laboratory
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Our missions
• To perform and standardize the pre-clinical characterization of nanomedicines
• To identify and characterize critical parameter related to nanomaterial interaction with biological systems
• To develop improved analytical methods to answer regulators’ needs
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Who are the Core Members?
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Who are the Satellite labs?
• CyberNano, Nates, FR
• FORTH Heraklion, GR
• INL, Braga, PT
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Why EUNCL?
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EUNCL Concept
Regulators(EMA, FDA, National Agencies)
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How does EUNCL work
EUNCL is funded under H2020 Framework programme
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EUNCL offer
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Standardized and validated SOP
The Standard Operating Procedures (SOPs) have been qualified and validated in all the laboratories of the EU-NCL consortium..
Quality controls are defined according to the ISO 17025
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Step1
• Definition/transfer of the SOPs and of the quality controls
• Qualification: inter-laboratory comparison
Step2• “Bugged” samples to test our problem
solving capability
Step 3• Validation of the laboratories (comparison
with results from NCI-NCL)
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Nanomed Translation Hub
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Application process
Who can apply?
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TNA numbers
• After 2 TNA campaigns• 23 applications so far
– 15 accepted to step 2– 8 entered characterisation
• More and more applications comes from industry (SMEs and Large)• 90% cancer focus in TNA1, 67% in TNA2
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Applications’ origine
Switzerland
Germany
Poland
Italy
France
Spain
Netherlands
UKIsrael
Denmark
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Applicants’ profile
Cupido Workshop, Chilly-Mazarin
TNA1
TNA2
0
1
2
3
4
5
6
7
SME ReserachInstitutte
University Largecompany
5
3 3
0
7
3
2
1
TNA1 TNA2
Applications
Treatment
VaccinDiagnosis
Imaging
Cancer90%
not specific10%
TNA1
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Cancer67%
Alzheimer16%
not specific17%
TNA2
Type of nanomaterials
STEP1
STEP2
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Liposome
Dendrimer
Metalic NP
Polymer
Protein
MicelleOxyde
Liposome
Dendrimer
Metalic NP
Polymer
Protein
Micelle
Lessons learned
• Role of EUNCL evolves– Toward advice and support– Help prepare better
application
• Maturity of projects– Advanced vs. Early stage– Difficulties in delivering GMP-like batches
• Main application drawback– Material quality & quantity– Key data missing
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Regulatory environment
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• Looking forward Cupido’sapplication
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Source: www.cupidoproject.eu
Cupido Workshop, Chilly-Mazarin3/21/2018
