EPAA Projects: 2015 developments

Transcription

1 EPAA Projects: 2015 developments Dr Patrick Sinnett-Smith EPAA Industry Co-chair, Pfizer Annual Conference European Parliament, Brussels

2 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

3 Action Programme Consensus-based The next 5 years ( ) 4 Priorities: 1-Regulatory acceptance and the 3Rs 2-International convergence 3-New scientific research needs 4-Dissemination and Communication 3

4 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

5 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

6 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

7 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

8 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

9 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

10 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, 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, May 2015 EPAA-EDQM workshop: Clostridial Vaccines workshop BSP 130, Egmond aan Zee, the Netherlands, 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, September

11 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

12 Activity report Communication EPAA representation at external 3Rs events EUSAAT 2015 (European Society for Alternatives to Animal Testing) September, Linz, Austria EUROTOX 2015: 51st Congress of the European Societies of Toxicology Bridging Sciences for Safety, September 2015, Porto, Portugal International Alliance for Biological Standardization (IABS),16-18 September, Egmond aan Zee, the Netherlands 12

13 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

14 Membership 36 companies 7 Sectors 5 DGs of the European Commission Companies update Solvay + Blue-chip Chemicals company, since employees in 52 countries 15 Major R&D centers 14

15 Governance Gwenole Cozigou DG ENTR COMMISSION CO-CHAIR INDUSTRY CO-CHAIR Carlo Pettinelli DG GROW Tzutzuy Ramirez BASF Patrick Sinnett-Smith Pfizer Gianni Dal Negro GSK Industry Co-chair 2016: Dr Gianni Dal Negro, GSK 15

16 Questions & Answers 16