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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?

Cupido Workshop, Chilly-Mazarin

EUNCL Concept

Regulators(EMA, FDA, National Agencies)

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How does EUNCL work

EUNCL is funded under H2020 Framework programme

Cupido Workshop, Chilly-Mazarin

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

Cupido Workshop, Chilly-Mazarin

Applications’ origine

Switzerland

Germany

Poland

Italy

France

Spain

Netherlands

UKIsrael

Denmark

Cupido Workshop, Chilly-Mazarin

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

Cupido Workshop, Chilly-Mazarin

Cancer67%

Alzheimer16%

not specific17%

TNA2

Type of nanomaterials

STEP1

STEP2

Cupido Workshop, Chilly-Mazarin

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

Thank You

• Simon.baconnier@cea.fr

• tna@euncl.eu

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