RRI: lessons learned fromEUNCL

Patrick Boisseau, coordinator

EUNCL is the

European Research Infrastructure

for the preclinical

Characterisation of Nanomedicines

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

Innovation chain in nanomedicine

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EUNCL offer

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Application to EUNCL

Applications’ origineFrance

Germany

UK

Poland

Italy

Spain

Swizerland

Netherlands

Israel

DenmarkGrece Ireland

Targeted diseases

Cancer

Alzheimer

Other

Passive targeting

Type of nanomaterials

Liposome

Dendrimer

Metalic NP

Polymer

Protein

Micelle

Oxyde

SilicaNP

Virosome

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)

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

See you next time at EUNCL ☺

www.euncl.eu

EUNCLab

www.euncl.eu