RENAMA The Brazilian Network for Alternative Methods

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Rubens Amaro da Rocha
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1 RENAMA The Brazilian Network for Alternative Methods Luiz Henrique Mourão do Canto Pereira National Coordinator for Biotechnology and Health Ministry of Science, Technology and Innovation Progress on alternative in vitro methods for the safety assessment of chemicals and their impact on human health: international and Brazilian views 1 st April 2015

Technology and Innovation Progress on alternative in vitro methods for the safety

2 Outline First Steps Vision and motivation to create RENAMA Institutional structure Governance Interlab initiative Recent Initiatives Call for proposals First validation (HET-CAM) Some ongoing projects Associated Labs Next Steps International cooperation actions

Initiatives Call for proposals First validation (HET-CAM) Some

3 First Steps Vision and motivation to createrenama Institutional structure Governance Interlab initiative

4 Vision and motivation to create RENAMA Lack of existing initiatives related to alternative methods until 2010 To promote sinergy between research groups; To adopt and develop alternative methods for replacement or reduction of animal use in research and regulatory (eg non-clinical trials); To create a national infrastructure (labs and human resources); To promote economic efficiency of public funds

replacement or reduction of animal use in research and regulatory (eg non-clinical trials); To

5 The Network is aimed to the adoption, development and validation of alterative methods; including technology catching-up and supplying services for both public and private sectors

6 Ministerial Act number 491/2012 Created the Rede Nacional de Métodos Alternativos - RENAMA and your structure under the Ministério da Ciência, Tecnologiae Inovação - MCTI, which willbe supervised by a Steering Committee RENAMA s objetives: Rede Nacional de Métodos Alternativos RENAMA I. Stimulate the adoption of alternative methods via supportandtraining; II. Monitor the performance of RENAMA s Labs via interlab assays; III. Promote the quality of assays; IV. Stimulate the implementation of quality systems and GLP principles; and V. Promote the development, validation and certification of newalternativemethods.

Stimulate the adoption of alternative methods via supportandtraining; II. Monitor the performance of RENAMA s Labs via interlab assays; III.

7 RENAMA is composed by two different lab categories: 1. Central Labs Rede Nacional de Métodos Alternativos RENAMA 2. Associated Labs -public or private institutions,com reconhecida competência na realização e desenvolvimento de métodos alternativos ao uso de animais de experimentação; -itshouldcontributetothedissemination/developmentofalternative methods and offer its laboratorial infrastructure to RENAMA -anagreementfortechnicalcooperationbetweenthecentrallabsandtheassociatedlabis necessary for joining RENAMA All RENAMA laboratories should have R&D activities

animais de experimentação; -itshouldcontributetothedissemination/developmentofalternative methods and offer its laboratorial infrastructure

8 Steering Committee: I Ministério da Ciência Tecnologia e Inovação MCTI (coordinates); II - Instituto Nacional de Metrologia Qualidade e Tecnologia - INMETRO; III - Instituto Nacional de Controle de Qualidade em Saúde - INCQS; IV - Laboratório Nacional de Biociências - LNBio; V Associated Labs representative; VI Agência Nacional de Vigilância Sanitária ANVISA/MS; VII - Centro Brasileiro de Validação de Métodos Alternativos - BraCVAM; VIII - Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq; IX - Agência Brasileira de Desenvolvimento e Inovação - ABDI; X - Conselho Nacional de Controle de Experimentação Animal - CONCEA.

Agência Nacional de Vigilância Sanitária ANVISA/MS; VII - Centro Brasileiro de Validação de Métodos Alternativos - BraCVAM; VIII - Conselho Nacional de

9 RENAMA s Steering Committee mandate: to oversee RENAMA s activities; to define RENAMA s strategic actions; to deliberate labs proposals for association to RENAMA; to evaluate projects under development within RENAMA; and to deliberate RENAMA s projects continuity or interruption.

for association to RENAMA; to evaluate projects under development

10 2011 Organization and management 2011 s first rounf of funding to Central Labs for setting up an infrastructure to run the following tests Citotoxicityin vitro (Guideline 129); Bovine Corneal Opacity and Permeability Test - BCOP (Guideline 437); Photo-cytotoxicity (Guideline 432); Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Guideline439); Monocyte Activation Test (MAT); Interlab assays First round ( ) to evaluate RENAMAFlux System and also a pilot for RENAMA Labs Citotoxicityin vitro (Guideline 129); To establish the viability of RENAMAFlux System; Identify gaps and issues that compromised the results qualityi; Five labs enrolled

Epidermis Test Method (Guideline439); Monocyte Activation Test (MAT); Interlab assays First round (2013-2014) to evaluate RENAMAFlux System and also a pilot for

11 RENAMAFlux System One-stop-shop for interlab assays; Assure that raw data is automatically uploaded; Initiate GLP principles culture.

12 Recent Initiatives Call for proposals First validation (HET-CAM) Some ongoing projects Associated Labs

13 i) Call for Proposals MCTI/CNPq - Nº 25/ Apoio a projetos para estruturação da Rede Nacional de Métodos Alternativos RENAMA 10 projects were selected; Theme 1 Fund projects for the implementation of validated alternative methods; Theme 2 Fund project(s) for the development and validation of Reconstructed Human Epidermis Test Method (Guideline 439).

projects for the implementation of validated alternative methods; Theme 2 Fund

14 ii) Call for proposals (2014): In silico trials (LNBio) The call was designed to offer computational tools for screening of small molecules candidates for new products, drugs or cosmetics; Projects from the following institutions were selected Cristália Produtos Químicos e Farmacêuticos LTDA. Eurofarma Laboratórios S/A Fundação Oswaldo Cruz Grupo Boticário Instituto de Tecnologia de Fármacos em Manguinhos (Farmanguinhos) Natura Inovação e Tecnologia de Produtos LTDA. Única Educacional

Cristália Produtos Químicos e Farmacêuticos LTDA.

15 2014 s projects iii) 2014 Funding of a validation study - HET-CAM - under RENAMA iv) Establishment of transgenic cell lines for in vitro assays

16 Interaction with regulatory bodies and private sector MCTI is holding meetings with ANVISA and CONCEA in order to promote the acceptance of alternative methods by the regulatory.; As result, the Board of ANVISA has accepted 17 validated alternative methods ; MCTI is holding meetings, through ABDI, with representatives from the private sector in order to map the industry needs for toxicological studies.

; As result, the Board of ANVISA has accepted 17 validated alternative methods ; MCTI is holding

17 Associated Labs 22 labs requested association at RENAMA Steering Committee reached a decision to accept 18 labs 4 labs were requested to provide further information

18 Next steps International cooperation actions

19 International collaborations Joint Research Centre European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM) MERCOSUL NIH Regional Plattform US-Brazil Collaborative Research Program

20 actions Human Resources Training 2 nd call for proposals Congress Amendments Continuous flux for Associated Labs

21 Thank you!

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