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Thematic brokerage workshops Workshop 7: EU-U.S Cooperation

The European Nanomedicine Characterisation Laboratory Susanne Bremer-Hoffmann Joint Research Centre European Commission NMBP 14-2017 Regulatory Science Framework for assessment of risk benefit ration of Nanomedicines and Biomaterials. Thematic brokerage workshops Workshop 7: EU-U.S Cooperation

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Thematic brokerage workshops Workshop 7: EU-U.S Cooperation

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  1. The European Nanomedicine Characterisation LaboratorySusanne Bremer-HoffmannJoint Research CentreEuropean CommissionNMBP 14-2017 Regulatory Science Framework for assessment of risk benefit ration of Nanomedicines and Biomaterials Thematicbrokerage workshops Workshop 7: EU-U.S Cooperation EU Brokerage Event on Kets in Horizon 2020 Strasbourg, 1st October 2015 Regulatory Science Framework for Nanomedicinesand Biomaterials

  2. Outline Some institutional information on our organisation and our skills and expertise Introduction into a European transnationalinfrastructure in nanomedicine (funded by European Union’s Horizon 2020 research and innovation program) Regulatory Science Framework for Nanomedicinesand Biomaterials

  3. Joint Research Centre EUROPEAN COMMISSION DIRECTORATES GENERAL JRC DIRECTORATES INSTITUTES European Reference Laboratories, Centres & Bureaus UNITS SCIENTIFIC UNITS Regulatory Science Framework for Nanomedicinesand Biomaterials

  4. The Mission of the Joint Research Centre As the Commission's in-house science service, the Joint Research Centre's mission is to provide EU policies with independent, evidence-based scientific and technical support throughout the whole policy cycle. Working in close cooperation with policy Directorates-General, the JRC addresses key societal challenges while stimulating innovation through developing new methods, tools and standards, and sharing its know-how with the Member States, the scientific community and international partners. Regulatory Science Framework for Nanomedicinesand Biomaterials

  5. Institute for Health and Consumer Protection Science for a healthier life Regulatory Science Framework for Nanomedicinesand Biomaterials

  6. Policy Support Areas ● Alternatives to Animal Testing ● Food and Consumer Products ● Genetically Modified Organisms ● Public Health ● Nanotechnology Regulatory Science Framework for Nanomedicinesand Biomaterials

  7. Nanomaterials in food and consumer products • Scientific and policy input for the development of the definition of nanomaterial (2011/696/EU, review in 2014) Safety assessment of nanomaterials • bridge the gap: available scientific results vs. regulatory data needs • Standardized protocols for toxicity testing • OECD Working Party for Manufactured Nanomaterials Provision of tools • Repository of Representative Nanomaterials for Testing • Databases on nanomaterial properties • Methods for detection and tracing • Validating of advanced analytical methods • Establishment of an infrastructure for the characterisation of nanomedicines Key activities Regulatory Science Framework for Nanomedicinesand Biomaterials

  8. Facilities • State-of-the-art laboratories for analytical chemistry, toxicology, nanobiosciences and molecular biology Multidisciplinary team Regulatory Science Framework for Nanomedicinesand Biomaterials

  9. Technologies available for nanomedicine characterisation in the JRC

  10. Competitive Research ProjectsPolicy Support – Strategic Research MARINAManaging Risks of Nanomaterials NANoREG A common European Approach to the Regulatory Testing of Nanomaterials NANODEFINE Development of methods and standards supporting the implementation of the EC definition of nanomaterial (collaboration with IRMM) NANOMILEEngineered nanomaterial mechanisms of interactions with living systems SMART-NanoSensitive MeAsuRemenT, detection, and identification of engineered NANOparticles in complex matrices EU-NCL European Nanomedicine Characterization Laboratory Regulatory Science Framework for Nanomedicinesand Biomaterials

  11. 1. Providing technical/scientific expertise to policy makers, regulators and • harmonisation/standardisation bodies e.g. International Pharmaceutical • Regulators Forum by: • Harmonisation of terminology and classification • Exchange and mapping of general Critical • Quality Attributes in collaboration with the FDA and MHLW • 2. Developing, optimising (of existing methods) and validating methods • assessing quality and safety of products supporting the authorisation of • urgently needed health care products • 3. Investing in pre-standardisation and harmonisation efforts in nanotechnology • 4. Partner in the EU-NCL project (Grant Agreement No 654190) Supporting the advancement of regulatory science in the area of nanomedicines by:

  12. 1st Workshop of the national nanomedicine platforms June 2015 • 13 out of 16 national platforms presented their organisation incl. memberships as well as regional competences, national priorities and existing expertise/ infrastructures/ resources • Information exchange on the various funding policy initiatives and dialogues with the ministries and funding agencies about steps to be taken in order to improve R&D and translation of nanomedicine in the individual Member States • Sharing experiences on regulations in • Europe as well as on the approval of • clinical trials and authorisation of • products Regulatory Science Framework for Nanomedicinesand Biomaterials

  13. EU Nanomedicine Characterization Laboratory (EU-NCL) the first European transnational infrastructure in nanomedicine- On behalf of the consortium European Union’s Horizon 2020 research and innovation program under grant agreement No 654190. Regulatory Science Framework for assessment of risk-benefit ratio of Nanomedicines and BiomaterialsNMP14-2017

  14. Our Mission • To provide a trans-disciplinary testing infrastructure covering a comprehensive set of preclinical characterisation assays (physical, chemical, in-vitro and in-vivo biological testing) facilitating understanding of biodistribution, metabolism, pharmacokinetics, safety and immunological effects of Med-NPs. • To foster the use and deployment of standard operating procedures (SOPs), benchmark materials, and quality management for the preclinical characterisation of Med-NPs. • To promote inter-sectorial and inter-disciplinary communication among key drivers of innovation, especially between developers and regulatory agencies http://dev.eu-ncl.eu/ Regulatory Science Framework for Nanomedicinesand Biomaterials

  15. Who we are EU-NCL: a distributed infrastructure combining complementary expertise Physico-chemistry Nano4Life 2015, Swansea, UK Quality Biologicalin-vivo Biologicalin-vitro

  16. Our Objectives • To perform and standardize the pre-clinical characterization of nanomaterials intended for medical therapies in Europe • To accelerate translation of engineered nanoparticles for medicine applications to medicinal products • To improve quality of data in IMP applications by using recognised and standardised methods • To support product developer by addressing feedback of decision makers regarding nanospecificproperties • To identify and to characterize critical parameter related to nanomaterial interaction with biological systems Nano4Life 2015, Swansea, UK

  17. Regulators (EMA, FDA, National Agencies) EU-NCL Concept

  18. What will the EU-NCL offer Nano4Life 2015, Swansea, UK Regulatory Science Framework for Nanomedicines and Biomaterials

  19. How will EU-NCL work Nano4Life 2015, Swansea, UK Regulatory Science Framework for Nanomedicines and Biomaterials

  20. What can we provide • Access to a trans-disciplinary testing infrastructure allowing a detailed nanocharacterisation; providing a final report on quality and safety of the tested material (→ First call for applications is expected for summer 2016) • Standard operating procedures (SOPs) for the non-clinical characterisation of Med-NPs • Knowledge base to be used by industry, regulators, product developer without reference to individual products (IP protection) • To promote inter-sectorial and inter-disciplinary communication among key drivers of innovation, especially between nanomedicine developer and regulators Regulatory Science Framework for Nanomedicinesand Biomaterials http://dev.eu-ncl.eu/

  21. Contact details Disclaimer: The opinions expressed in this presentation do not necessarily represent the official view of the European Commission Adressedtopic

  22. Back-up slides Adressed challenge/PPP

  23. Technologies available for nanomedicine characterisation in the JRC

  24. EU Definition of Nanomaterials • Commission Recommendation on the definition of nanomaterial (2011/696/EU, review in 2014) • Scientific and policy input for the development of the definition • Support to Commission services for the review of the definition scheduled for December 2014 • JRC Reference Reports • Requirements for size measurement: capabilities of available methods • Reliable and validated measurement methods • Reference materials • Principal customers: • ENV, SANTE, GROW 24

  25. Working Party for Manufactured Nanomaterials • Recommendation of the OECD Council on the Safety Testing and Assessment of Manufactured Nanomaterials • Preparation, contribution, and chairing of Expert Workshops (Environmental Fate & Eco-Toxicology; Physical- Chemical Properties; Genotoxicity, Toxicokinetics, Categorisation, Read Across) • 8 Test Guidelines or Guidance Documents project proposals to address specifically NMs • Co-chairing of 3 Steering Groups • "Testing Programme": JRC Reports on SiO2, TiO2, MWCNT, CeO2, ZnO Characterisation and Physico-Chemical Properties 25

  26. Regulatory challenges • ‘Nanosimilars’ - evaluation of follow-on nanomedicine products • Step-wise comparability studies • ‘Next generation’ nanomedicines • Advances in nanoscience leading to creation of more complex, hybrid structures • Wave of new pharmaceuticals, imaging agents Unclear regulatory path • combination products • borderline products

  27. Who we are (satellite labs) • CyberNano, Nancy, FR • University Paris-Descartes, FR • FORTH Heraklion, GR • Institute of High Pressure Physics , Warsaw, PL • INL, Braga, PT • RIVM, Bilthoven, NL • Swansea University, UK • University of Minho, PT • Adjuvatis, Lyon, FR • BIONAND, Malaga, SP • University of Bordeaux , FR • Brno University of Technology, CZ • Charles University Prague, CZ • Ciber BBN, SP Nano4Life 2015, Swansea, UK

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