Main achievements & Progress in Gianni Dal Negro, GlaxoSmithKline Industry Co-Chair EPAA Steering Committee

Transcription

1 Main achievements & Progress in 2011 Gianni Dal Negro, GlaxoSmithKline Industry Co-Chair EPAA Steering Committee

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3 Overview of EPAA activities in 2011 Focus on Integrated Testing Strategies (annual theme) Progress of ongoing projects with longterm objectives (e.g. new perspectives on safety, vaccines consistency approach) Dissemination and Communication on 3Rs Identification of metrics (Key Performance Indicators) to further improve efficiency

4 HIGHLIGHTS Focus on Integrated Testing Strategies (annual theme) Joint EPAA-CEFIC Workshop September, on Optimized testing strategies for skin sensitization - the Local Lymph Node Assay (LLNA) and beyond Cross-sector sharing of experience on various testing and non- testing approaches Broad recognition that combination of methods (ITS) can help address the limitations of individual methods REDUCTION REFINEMENT REPLACEMENT

5 HIGHLIGHTS Focus on Integrated Testing Strategies (annual theme) ITS Workshop 26 September Sharing of ITS experience amongst: - companies - companies and regulators - sectors (companies & regulators from various sectors) (more about this WS in the afternoon session) REDUCTION REFINEMENT REPLACEMENT

6 New perspectives on safety - Stem cells (how to assess repeated dose toxicity without animal testing) - Stem cells workshop, 4-5 October, Ispra Analysed ongoing activities on stem-cell based toxicity testing within current industry and FP-funded programmes (e.g. IMI, SEURAT-1) Discussed whether the available techniques are sufficient or new technologies should be developed, validated and adopted Recommendations for future short- & long-term activities include: Better harmonisation of research initiatives through an international forum Rely on common quality standards, improved communication, sharing of information, technologies and training Further research needed on: stem cell derived organotypic (3D) cultures, carcinogenicity assays, adaptive response vs. adverse perturbation, translational aspects Need for a communication network to share information (e.g. on reference compounds, organ toxicities) REDUCTION REFINEMENT REPLACEMENT

7 New perspectives on safety (how to assess repeated dose toxicity without animal testing) Employing latest science in Computational chemistry & systems biology - Analysed 2010 Workshop s recommendations - Ensure complementarity with ongoing initiatives, e.g. SEURAT-1, DILI (IMI), Tox21, virtual liver projects (at EPA and in Germany) - Prepare for an expert meeting in 2012 REDUCTION REFINEMENT REPLACEMENT - Objective to design research packages needed for developing an integrated model of mitochondrial / liver toxicity

8 Absorption, Distribution, Metabolism, Excretion (ADME) Toxicokinetics Workshop, October, Ispra Examined potential for further integration of PBTK modelling into the prediction of in vivo dose-response curves without animal experiments Generated recommendations that will be pursued to advise the next calls for FP7 or other research programmes REDUCTION REFINEMENT REPLACEMENT

9 Absorption, Distribution, Metabolism, Excretion (ADME) REDUCTION REFINEMENT REPLACEMENT Methodological recommendations Need to improve in vitro tests for oral absorption rate for absorption rate via inhalation, for renal excretion rates High-ThroughPut assays for metabolic profiling and rates (quantitative) Strategic recommendations Creation database in EU of in silico/in vitro based PBTK models including physiological parameters Review/evaluation of PBTK platforms (commercial and freeware) Collect and set up database for human kinetic data, including industrial chemicals and pharma data Connect with other ongoing activities, e.g. SEURAT-1, Tox Cast, Tox21

10 Encouraging involvement of young scientists from diverse areas to increase knowledge and facilitate regulatory acceptance of 3Rs In 2011, an EPAA Scientific Advisory Committee oversees the implementation of the 2010 awarded research project of Dr F. Spoeler in collaboration with BASF as industrial partner (more information in the presentation of Dr Spoeler) A subteam of the Platform on Science prepared the next call for proposals to be issued in January 2012 (deadline for applications June 2012)

11 Vaccines consistency of production approach Kick off meeting, 7 April, Brussels Invited national and international regulators to join the Technical Committee to define specific projects 1 st meeting of the Technical Committee on 30 September >>>Next steps REDUCTION REFINEMENT REPLACEMENT Agree priority research projects or proof of concept for specific alternative tests for human or veterinary vaccines (More information in the presentation of C. Hendriksen)

12 Extended One-Generation Reproductive Toxicity Study REDUCTION REFINEMENT OECD adopted the method in July (TG 443) EPAA promotes its acceptance by regulators Facilitates discussions between industry and regulators for application in the context of REACH Cefic coordinates industry s input into the CARACAL expert subgroup A joint publication on the feasibility studies of BASF, Bayer, Dow and Syngenta is under preparation Along with the scientific data, legal and regulatory elements will be considered for progressing further this approach REPLACEMENT

13 Dissemination and Communication on 3Rs Continued to support the market place concept, as mechanism to facilitate access to information - connect those who have or need information Thematic review of reproductive toxicity methods Prepared the 2 nd step, review of in vivo 2R methods Provide a more complete picture of the status and use of all 3Rs methods and approaches for this toxicity >>>Next questionnaire to industry planned for early 2012

14 Dissemination and Communication on 3Rs Engaged a full time Communication professional Continued to improve communication tools (e.g. website, flash reports, ITS fact sheet) to advance understanding of 3Rs approaches Communication prize: launched in June a call for assays related to the year theme of ITS Contributed to the 8 th World Congress on Alternatives (21-25 August, Montreal) EPAA session on PPPs Sponsored a number of 3Rs related external initiatives (e.g. WC8, FRAME training schools, IVTIP Congress on reconstructed skin models)

15 Key Performance Indicators for EPAA Identified simple metrics to further improve efficiency To give priority to projects offering clear potential for 3Rs impact 3 KPIs identified per Platform Will next be assessed by the Platforms and used further to communicate on progress

16 CONCLUSIONS In 2011, the EPAA continued making progress in line with the 5-years Action Programme agreed in 2010 Under the annual theme it succeeded to highlight the importance, usefulness and limitations of existing ITS Continued to share knowledge and experience amongst industry sectors thereby maximising opportunities for 3Rs impact Continued to attract interest of regulators, NGOs and academia Increasing expectations call for the partners to progress further this powerful and unique public-private partnership Clear expectations for building international collaborations involving overseas institutions

17 Special thanks to : Acknowledgements the Chairs and members of the 3 Platforms for their good work and valuable input the members of the Mirror Group for their constructive advice Thank you for your attention