Activities Reporting Dr Tzutzuy Ramirez

Transcription

1 Activities Reporting Dr Tzutzuy Ramirez BASF, Industry Co-Chair of EPAA Steering Committee 1

2 Regulatory acceptance of alternative approaches as a Lead theme 2014 at a glance Preparing for the Future Progressed ongoing projects & initiated 1 new (Exposure prediction) Restructured for enhanced governance & leadership by partners Engaged with: - new audiences (EP, CARACAL) - international audiences (9 th World Congress, IIVS) 2

3 Partnership Update EPAA brings together 36 companies from 7 sectors, 5 DGs of the European Commission SCA Hygiene products joined as new corporate member, establishing links between EPAA and the sector of non-woven products Collaboration and interaction in projects continues also with non-member organisations, e.g. NC3Rs, several CROs and animal welfare organisations that share common goals 3

4 ONGOING PROJECTS 4

5 Lead theme: Regulatory acceptance of 3Rs approaches Workshop organised on 22 September, Brussels Knowledge sharing to facilitate regulatory decision making 50 participants from national, EU regulators & industry to: - share knowledge on the use of alternatives and across sectors - discuss on how to overcome potential hurdles for regulatory acceptance of alternative approaches Recommendations from this Workshop will be presented later on today s programme Comprehensive report will be published in a peer reviewed journal 5

6 ONGOING PROJECTS A Stem Cells (1/2) 1. Work Group on Fundamental Research on Stem Cells Prepared a Research Prospectus (RP) to promote concrete areas of research based on recommendations of 2013 WS The RP was discussed with DG RTD in June Full publication reporting from the 2013 WS was prepared for submission to peer reviewed journal The EPAA team encouraged the participants of the WS to submit a research proposal under H2020 call for Personalizing Health & Care PHC New approaches to improve predictive human safety testing 6

7 ONGOING PROJECTS A Stem Cells (2/2) 2. Work Group on Stem Cells Communication Organized the 2 nd International Stem Cells Forum hosted by University of Liverpool UK, 3-4 September Sharing of practical experience amongst various research consortia and teams from EU and US. Recommendations will be published in a peer-reviewed journal 7

8 ONGOING PROJECTS B Exposure prediction (ADME) Initiated project for developing an open access web tool for userfriendly in vitro to in vivo and in vivo to in vitro exposure prediction Pilot project (18 months) started at HSL (Health and Safety Laboratory), in UK, in June 2014 Funded by EPAA, conducted by HSL Expected to support development of more reliable in vitro approaches 8

9 ONGOING PROJECTS C Advancing 3Rs in Regulatory Toxicology: Carcinogenicity Publication reporting from the 2013 Carcinogenicity WS Project at University of Wageningen, NL, funded by EPAA Extending an existing database (Sistare et al. 2011) with data on pharmaceutical compounds Expected to generate recommendations for ICH to waive the 2- year carcinogenicity studies for pharma chemicals 9

10 ONGOING PROJECTS D Science Award 2012 : final steps Research project of Dr Nils Kluever, Leipzig, Germany Increasing the predictive capacity of the (zebra) fish embryo test Project successfully completed under the supervision of the Science Award Scientific Advisory Committee (SASAC) Manuscript submitted for publication to a peer reviewed journal in July

11 ONGOING PROJECTS E Acute toxicity project Following recommendations of EPAA and HSI at CARACAL in 2012, the EC presented a proposal to modify REACH Annex VIII on Acute toxicity at the CARACAL meeting in July The proposal provides a waiver for acute toxicity testing via the dermal route for substances which are non-toxic via the oral route and was received well by the Member States and stakeholders Final EC proposal will be discussed with the REACH Committee More information will be provided at a next presentation by Tom Holmes 11

12 ONGOING PROJECTS F Optimized strategies for skin sensitization Discussions across sectors and with ECHA continue to prepare a next joint EPAA-Cefic LRI WS to share latest progress in 2015 Poster presented at the 9 th World Congress on Alternatives, Prague, August 2014 EPAA/CEFIC LRI activities progressing non-animal testing strategies More information will be presented by Annette Mehling later today 12

13 ONGOING PROJECTS G Vaccines Consistency of production approach Human rabies: Pre-validation study ongoing to identify suitable reagents for an ELISA test to replace the NIH (National Institutes of Health) in vivo test on mice. Presentation by J.M. Chapsal at 9 th World Congress, Prague. Clostridial vaccines: International collaborative study to assess concordance of novel in vitro tests with the existing in vivo tests. Initial analysis of results shows good correlation for the Minimum Lethal Dose assays. Vet rabies: Monitoring the human rabies pre-validation study to assess suitability for replacing the NIH test with in vitro ELISA for veterinary rabies vaccines lot release Completion of experimental work and data analysis expected by end of

14 COMMUNICATION ACTIVITIES 14

15 Communication activities Addressing new audiences EPAA presentation at the EP breakfast organised by the MEP Sidonia Jedrzejewska on Animal Testing Science or Tradition: what future to alternatives to animal testing? in February Article about EPAA published in the E. Parliament Magazine EPAA presentation at the EP event Putting Animal Welfare at the Heart of the EU organized by Eurogroup for animals in October EPAA presentation at the CARACAL meeting on 10 November, in Brussels 15

16 Communication activities Addressing international audiences 9 th World Congress on Alternatives, Prague, August EPAA supported the Congress and presented: EPAA - a key player in shaping the future of 3Rs presentation by Gwen Cozigou (EC Co-Chair) Poster on Optimized strategies for Skin sensitization Reference to EPAA activities made during presentations of members Dissemination of EPAA communication material at the DG JRC booth 16

17 Communication activities Addressing international audiences Training video on the BCOP (Bovine Corneal Opacity and Permeability) in vitro eye irritation test method -Developed by IIVS (Institute for In Vitro Sciences) in US, sponsored by EPAA -The video is available at no cost on the EPAA website -Will be used with different voiceovers (e.g. Chinese) to provide lab technicians effective guidance on this alternative OECD accepted method 17

18 Concluding Facts and Figures for ongoing projects on Science and Regulation 3 of them focussing on international cooperation Vaccines Consistency Approach project Harmonization of 3Rs in Biologicals project Stem Cells project: International Forum 2 EPAA scientific workshops (Lead theme on Regulatory acceptance, Stem cells International Forum) 1 publication in peer-reviewed journal, 3 peer-review publications in preparation 4 events addressing external audiences (2 at E. Parliament, World Congress on Alternative Methods and CARACAL) 18

19 EPAA restructuring Enhanced governance and leadership by the partners Pre-requisite for having leader from industry and/or the E.Commission Clearer criteria for new projects (i.e. impact to the 3Rs, avoid duplication, realistic, clear short term and long term milestones and deliverables, go / no-go decision points included in the project plan) Streamlined activities / reduced structural complexity Merged the previous 2 platforms into one Projects Platform aiming at more efficiency and coordination between the 7 ongoing projects related to Science and Regulation Reviewed the budget (reduced costs) in order to remain sustainable under the current resources contributed by the parnters 19

20 Preparing for the future Current 5-year term ends in December 2015 Industry & EC agreed to renew EPAA for a 3rd term ( ) Partners strongly recommend to keep EPAA as a unique, neutral platform that enables the exchange of ideas and experiences from different stakeholders The Industry Co-Chair for 2015 will be Dr Patrick Sinnett-Smith (Pfizer) 20

21 Many thanks for your attention! 21