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REFINE

Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices.
REFINE is a Research and Innovation Action to refine the current regulatory scientific framework for nano(bio)material-based medicinal products and medical devices. It will identify, design and test new characterization assays for enhanced regulatory assessment of innovative nanomedicines and biomaterials.


Publié le 6 janvier 2021


REFINE : Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

REFINE is a Research and Innovation Action to refine the current regulatory scientific framework for nano(bio)material-based medicinal products and medical devices. It will identify, design and test new characterization assays for enhanced regulatory assessment of innovative nanomedicines and biomaterials.

 

Starting date : Oct 2017 > Nov 2021    Lifetime:55 months


Program in support :

NMBP-2017 two-stage



 

Status project : in progress



CEA-Leti's contact :  

  • Simon Braconnier                                         

                                               

 

Project Coordinator: CEA-Leti 


Partners:  

  • Empa (CH) 
  • Bioanalytik-muenster European Research Services (DE) 
  • Biopraxis research (ES)
  • Amatsi Group, CEA-Leti (FR)
  • University Brighton, University Liverpool (GB)
  • Trinity College (IE) 
  • European Commission-JointResearch Center, Green Decision (IT)
  • Stiftelsen Sintef (NO)
  • Rijksinstituut voor Volksgezondheid en Milieu (NL)


Target market: n/a



Investment: € 8 mi

EC Contribution€ 8mi



 

Number of patents n/a

Stakes

  • REFINE is a Research and Innovation Action to refine the current regulatory scientific framework for nano(bio)material-based medicinal products and medical devices. It will identify, design and test new characterization assays for enhanced regulatory assessment of innovative nanomedicines and biomaterials.
  • CEA-Leti is coordinating the project and is aligning its development with results obtained within EUNCL infrastructure, which also coordinated by CEA-Leti.

  • The aim is to develop characterization assays to improve preclinical characterization of nanomedicines and better comply with the requirements of regulators in terms of assessing the safety of these nanomedicines before granting authorization for clinical trials. CEA-Leti is also coordinating the work package on community bridging because of its extensive European network of partners and collaborators in nanomedicine across areas ofscience, technology, industrialization, regulation, standardization and beyond: food, cosmetics, medical devices and nano safety.

  • Our Institute provides and develops new physical characterization assays for adaptation to the needs expressed by regulators and with the quality required for a future standard development and submission.

  • CEA-Leti produces and supplies Lipidots(r) as one of the relevant materials (a reference material) to be used for the qualification and validation of new or existing characterization assays in response to regulatory needs.


OBJECTIVES

  • REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanotechnologies and biomaterials. The core of the framework is development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by the relevant regulation using best fitting methods. The decision tree can identify the product’s specific regulatory issues and the priorities of both missing data and missing methods meeting these issues. Subsequently, it allows planning of a cost and time, efficient strategy for taking necessary measurements and progressing the best fitting methods. Our approach is aligned with the industrial R&D practice of stage gating.

  • The framework relevance for the most pressing regulatory issues can be demonstrated. These challenges include borderline products, nanosimilars and products combining several functionalities. We have identified the regulatory issues with European and foreign regulatory authorities as well as design methods for tiered decision tree building in line with contemporary
    scientific knowledge. Work has been performed on the analysis and prediction of the physiological distribution of nanomedicines and biomaterials and we have developed and validated the new analytical or experimental methods and assays required by the regulators. These developments have been achieved in a quality management system, ensuring possible standardization of our assays.

  • REFINE brings together a wide community of stakeholders in regulation, industry, science, technology development, patients
    and end-users in a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.


IMPACT

  • REFINE will place Europe at the forefront of regulation and risk-benefit assessment of medicinal products and medical devices based on nanotechnologiesand biomaterials.

  • The project will adjust preclinical characterization assays to the unmet medical requirements expressed by regulators.

  • It will deliver a Decision Support System to guide nanomedicine developers and regulators in preparing the regulatory documentation and performing preclinical characterization.