EPAA Projects: 2015 developments Dr Patrick Sinnett-Smith EPAA Industry Co-chair, Pfizer Annual Conference 2015 - European Parliament, Brussels
2015 in a nutshell Strategy: New Action Programme Activities: Projects workshops & publications Dissemination & Collaboration: Stakeholders interaction Commitment: Membership update 5 Peer - reviewed Publications 4 Scientific Workshops 2
Action Programme Consensus-based The next 5 years (2016-2020) 4 Priorities: 1-Regulatory acceptance and the 3Rs 2-International convergence 3-New scientific research needs 4-Dissemination and Communication 3
Action Programme Priorities 1- Regulatory Acceptance and the 3Rs Bridge the gap between development & acceptance of alternative methods Bring together Regulators and Regulated Share Good Practice and knowledge 4
Action Programme Priorities 2- International convergence Identify remaining barriers to acceptance of 3Rs methods Collaborate to facilitate international convergence and standardisation of new methods Promote Integrated Approaches on Testing and Assessment (IATA) 5
Action Programme Priorities 3- New scientific research needs Identify research gaps in development of alternative methods Highlight priorities for European research in the 3Rs Help shape the research funding agenda on alternatives 6
Action Programme Priorities 4- Dissemination & Communication Improve access to information & existing tools Build larger coalitions to promote Alternatives Encourage and promote the work of young European scientists Special focus on Refinement 7
Governance Structure Merger of the Platform on Science and Platform on 3Rs in Regulation to form a single Project Platform This reflects a reduction in the number of projects we support to allow greater focus. Review of the Mirror Group New members MEP Julie Girling Marko Susnik, UEAPME Nick Meade, Genetic Alliance 8
Activity report Projects Overview 2015: 7 Projects 1. Optimised strategies for assessing Skin sensitisation 2. Vaccines consistency approach 3. Acute Toxicity 4. User-friendly in vitro/in vivo exposure predictor 5. Biologicals 6. Advancing 3Rs in Regulatory Toxicology 7. Stem Cells (completed) 9
Activity report 4 Workshops in 2015 EPAA-Cefic LRI-Cosmetics Europe Joint cross-sector workshop on Alternatives for Skin sensitisation testing and assessment, Helsinki, Finland, 23-24 April 2015 EPAA-EURL ECVAM workshop on replacement of In Vivo Human Rabies Vaccine Potency Testing by in vitro Glycoprotein Quantification Methods: Results from the International Collaborative Study and Implementation Strategies, Arcachon, France, 10-11 May 2015 EPAA-EDQM workshop: Clostridial Vaccines workshop BSP 130, Egmond aan Zee, the Netherlands, 15-16 September 2015 EPAA Workshop: Modern science for better quality control of medicinal products Towards global harmonization of 3Rs in biologicals, Egmond aan Zee, the Netherlands, 15-16 September 2015 10
Activity report 5 Peer-reviewed publications Cozigou et al., The EPAA: Promoting Alternative Methods in Europe and Beyond, JAALAS, March 2015 Ramirez et al., Knowledge sharing to facilitate regulatory decisionmaking in regard to alternatives to animal testing: Report of an EPAA workshop, Regul Toxicol Pharmacol. Oct 2015 Basketter et al., Alternatives for skin sensitisation: Hazard identification and potency categorisation: Report from an EPAA/CEFIC LRI/Cosmetics Europe cross sector workshop, ECHA Helsinki, April 23rd and 24th 2015, Regul Toxicol Pharmacol. Nov 2015 De Mattia F et al., The Vaccines Consistency Approach Project: An EPAA initiative. Pharmeuropa Bio&SN, May 2015 Suter-Dick et al., Stem cell-derived systems in toxicology assessment, Stem Cells Dev. June 2015 11
Activity report Communication EPAA representation at external 3Rs events EUSAAT 2015 (European Society for Alternatives to Animal Testing) 20-23 September, Linz, Austria EUROTOX 2015: 51st Congress of the European Societies of Toxicology Bridging Sciences for Safety, 13-16 September 2015, Porto, Portugal International Alliance for Biological Standardization (IABS),16-18 September, Egmond aan Zee, the Netherlands 12
Activity report Dissemination 3Rs Laboratory Technician/Animal Caretaker Prize EPAA-IIVS training videos on alternative methods: BCOP Assay in English w. Chinese & Portuguese subtitles Available for free on DG GROW s Youtube channel 3T3 Phototoxicity Assay video training to follow 13
Membership 36 companies 7 Sectors 5 DGs of the European Commission Companies update Solvay + Blue-chip Chemicals company, since 1863 26000 employees in 52 countries 15 Major R&D centers 14
Governance Gwenole Cozigou DG ENTR COMMISSION CO-CHAIR INDUSTRY CO-CHAIR Carlo Pettinelli DG GROW 2014 2015 2016 Tzutzuy Ramirez BASF Patrick Sinnett-Smith Pfizer Gianni Dal Negro GSK Industry Co-chair 2016: Dr Gianni Dal Negro, GSK 15
Questions & Answers Grow-epaa@ec.europa.eu 16