EURL ECVAM. A broader role for greater impact. Maurice Whelan. Head of Systems Toxicology Unit and EURL ECVAM
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1 EURL ECVAM A broader role for greater impact Maurice Whelan Head of Systems Toxicology Unit and EURL ECVAM Institute for Health and Consumer Protection DG Joint Research Centre Meeting of the EP Intergroup on the welfare & conservation of animal for Animals February 2013
2 The European Union Reference Laboratory for Alternatives to Animal Testing Key responsibilities o Guide method development o Conduct validation studies o Facilitate regulatory acceptance o Promote uptake by end-users Established under the Directive 2010/63/EU on the protection of animals used for scientific purposes Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
3 Systems Toxicology Unit Effective 1 st October 2012 Validation Outreach Peer Review Dissemination EURL ECVAM Coordination HoU ~65 staff Action Management Quality Management Predictive Toxicology Assay Validation Assay Development and HTS Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
4 ICATM cooperation Stakeholder dialogue ECVAM Validation Process Key documents ICATM: Exchange Info. on promising submissions. Decide how to collaborate Relevance assessment: PARERE: regulatory relevance ESTAF: user relevance 1. Assessment of submitted test method Scientific aspects. Stakeholder relevance (priority setting). Optimisation (if necessary). Test Submission PARERE report ESTAF View ICATM: Review aspects of VS. Propose VMG members and observers Public input on planned Validation Study. Submission of existing information. 2. Planning & conduct of (Pre-)Validation Study (VS). Test method evaluation. Validation Project Plan (VPP) Validation Study Report (VSR) ICATM: Proposal of experts for ESAC WG supporting the ESAC peer review. 3. ESAC review of (1) VS conduct (2) VS conclusions (3) ESAC opinion on test method s validity for purpose. ESAC Request ESAC Reports & Opinion ICATM: Harmonised recommendations of validated test methods (if feasible). Comments on draft recommendation: PARERE ESTAF 4. Draft ECVAM Recommendations on validated test method. 5. Right to be heard process. Draft ECVAM Recommendation PARERE report ESTAF View Public input on draft ECVAM recommendations 6. Public Commenting Public Commenting Report 7. Finalisation of ECVAM recommendations (ER). Publication of ER + ESAC opinion + VSR. ECVAM Recommendation 4
5 Test Method Submissions Test Methods submitted - 16 for (Skin) sensitisation - 10 for Eye Irritation - 9 for Reproductive Toxicity (7 for Endocrine disruption) - 5 for Skin Irritation - 3 for Genotoxicity - 2 for neurotoxicity; 2 for acute tox.; 2 for skin penetration - 1 for QC vaccines; 1 without category; 1 for cardiotoxicity Status of test methods can be found at:
6 7 Validation studies / 11 Test Methods Human cryo-preserved hepatocytes and HepaRG cell line Metabolism/ Toxicokinetics Endocrine Disrupters ERTA on engineered cells and 2 ARTA in pipeline Up-regulation of protein markers in human DC cell lines Skin Sensitisation Validation Genotoxicity/ Carcinogenicity Eye irritation Comet assay, MN & Comet assay in reconstructed skin 2 reconstructed human tissue models
7 ICATM International Cooperation on Alternative Test Methods Founded in 2009 by EURL ECVAM (EU), JaCVAM (Japan), NICEATM-ICCVAM (USA), Health Canada, and KoCVAM (Republic of Korea). Recent interest from BraCVAM (Brazil) and Chinese Agencies. Working together at every step of the validation process (evaluation of submissions, design and execution of studies, peer review, recommendations, and development of guidance and guidelines). Plans for closer cooperation in strategy formulation.
8 ICATM International Cooperation on Alternative Test Methods Recent acceptance of 3 new OECD Test Guidelines and 1 Guidance Document, 2 draft test guidelines going through OECD process. Peer review of 4 validation studies underway and 1 test method recommendation in preparation. Total of 16 validation studies in progress. Agreement to develop a common web-based information system for ICATM activities. 8
9 5 Commission DGs; 3 EU Agencies 7 EU trade federations for 7 industry sectors 35 Companies Platform on Science 9
10 Projects of PLATFORM ON SCIENCE Systems biology Computational chemistry 3Rs Science Award Metabolism modelling Global cooperation Advancing 3Rs in RegTox Stem cells Platform on Science 10
11 Projects of PLATFORM ON 3Rs IN REGULATION Skin sensitisation testing strategies International harmonization of biologicals* Vaccines consistency approach Global cooperation Acute Tox EOGRTS * To be confirmed Platform on Science 11
12 Cooperation with US Agencies TOX21 Consortium Progress, Prospects and Outreach, September 2010, JRC, Italy. MTA: IHCP and EPA-NCCT September
13 Collaboration Agreement between IHCP/ECVAM and NIH National Centre for Advancing Translational Sciences
14 Computational methods Reports on Thresholds of Toxicological Concern (TTC) using modelling and chemo-informatics Key input to the COM Scientific Committee opinion Use of the TTC for Human Safety Assessment of Chemicals with focus on Cosmetics and Consumer Products (June 2012) Major impact on EFSA opinions Evaluation of the Toxicological Relevance of Pesticide Metabolites for Dietary Risk Assessment (June 2012) Exploring options for providing advice about possible human health risks based on the concept of TTC (July 2012) Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
15 Integrated Testing Strategy Chemical Structure & Properties Molecular Initiating Event Cellular Response Organ Response Organism Response Metabolism Penetration Electrophilic substance Key Event 1 Covalent interaction with skin proteins Key Event 3 Dendritic Cells (DCs) Induction of inflammatory cytokines and surface molecules Mobilisation of DCs Key Event 2 Keratinocytes responses Activation of inflammatory cytokines Induction cytoprotective genes Key Event 4 T-cell proliferation Histocompatibility complexes presentation by DCs Activation of T cells Proliferation of activated T-cells Adverse Outcome Inflammation upon challenge with allergen EURL ECVAM led project within the OECD Hazard Assessment Task Force
16 Delivering holistic solutions EURL ECVAM Strategy for Animal-free assessment of Skin Sensitisation Integration ESAC Opinion and EURL ECVAM Recommendation on DPRA and KeratinoSens Call for data DPRA, h- CLAT, KeratinoSens, others Modelling Proposed ITS for hazard identification ITS refinement including additional testing/validation (if needed) Submission to the OECD of SPSF (h-clat) ESAC opinion and EURL ECVAM recommendation on h- CLAT Expert consultation meeting on the proposed ITS and validation needs Submission to the OECD of a Guidance Document on an ITS for hazard identification full replacement Submission to the OECD of draft TGs (DPRA and KeratinoSens) Submission to the OECD of draft TG (h-clat) Milestones Deliverables Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
17 A scientific strategy for success o Understanding toxicological mode of action Exposure Initiating Event Organelle Effects Cellular Effects Tissue Effects Organ Response Individual Response Population Response o to rationally design integrated prediction systems o fit for the purpose of supporting safety decisions facilitating a shift towards a knowledge-driven paradigm for chemical risk assessment Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
18 The LUSH Science Prize awarded ( 50,000) to the JRC Institute for Health and Consumer Protection " for 21 st Century Toxicology Research.." Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
19 Safety Assessment Ultimately Replacing Animal Testing Towards the replacement of repeated dose systemic toxicity testing on animals 6 projects, 1 coord action, 70 institutions, 5 years, 50 MEuro, public-private partnership
20 GC WG SA WG MoA WG DA WG BK WG MoA WG SEURAT-1 Roadmap SEURAT-1 MAIN SEURAT-2 MAIN MoA RESEARCH STRATEGY MoA DESCRIPTION SEURAT-1 T&M CATALOGUE ITS ASSOSIATING CHEMICAL-MoA PROPSAL FOR REGULATORY DECISION EXPANDED APPLICATION DOMAIN BASED ON ALL SEURAT-1 OUTCOME SC WG Year
21 Achievements Genetically Protocols Model Functional Database Model Prototype of toxicity for on link data engineered liver stably cosmetics and at vitro the reporter-gene differentiated molecular protocol ingredients tissue vivo bioreactor warehouse level biokinetics and cell ipsc properties lines Chemical Cells exchange Watch this space!
22 Proving our concepts Knowledge describe selected AOPs to a sufficient extent so that they can be used as blueprints for system design. Systems demonstrate integrated systems for associating a chemical with an AOP category and predicting effect levels. Application use the information derived from predictive systems to support safety assessment processes and decisions. Ready for SEURAT-2!
23 Promoting a broader use of alternatives EURL ECVAM Search Guide Search principles & procedures, terms and guidance 7-step check list to ensure comprehensive searches Inventory of key resources Support to project authorisation process for animal experiments (Directive 2010/63/EU) Free from: Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
24 Looking ahead o o o o o Informing the European Chemicals Agency (ECHA) on how non-animal data can be used for CLP/REACH. JRC Report on progress since 2011 in the development, validation and acceptance of methods. Establishment and launch of the EU Network of Validation Laboratories (NETVAL). New collaborations with partners in the USA (FDA and NIH-NCATS) and China (SFDA) Positioning EURL ECVAM as a hub for translating science into 3R solutions. Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
25 Thank you for your attention Joint Research Centre (JRC) The European Commission s in-house science service Serving society - Stimulating innovation - Supporting legislation 25 Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission
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