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
st
1 April 2015
Rede Nacional de Métodos Alternativos – RENAMA
Outline
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First Steps
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Recent Initiatives
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Vision and motivation to create RENAMA
Institutional structure
Governance
Interlab initiative
Call for proposals
First validation (HET-CAM)
Some ongoing projects
Associated Labs
Next Steps
– International cooperation
– 2015-2016 actions
Rede Nacional de Métodos Alternativos – RENAMA
First Steps
•
•
•
•
Vision and motivation to create RENAMA
Institutional structure
Governance
Interlab initiative
Rede Nacional de Métodos Alternativos – RENAMA
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
Rede Nacional de Métodos Alternativos – RENAMA
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
Rede Nacional de Métodos Alternativos – RENAMA
Ministerial Act number 491/2012
Created the Rede Nacional de Métodos Alternativos - RENAMA and your structure under the Ministério
da Ciência, Tecnologia e Inovação - MCTI, which will be supervised by a Steering Committee
RENAMA’s objetives:
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Stimulate the adoption of alternative methods via support and training;
Monitor the performance of RENAMA’s Labs via interlab assays;
Promote the quality of assays;
Stimulate the implementation of quality systems and GLP principles; and
Promote the development, validation and certification of new alternative methods.
Rede Nacional de Métodos Alternativos – RENAMA
RENAMA is composed by two different lab categories:
1. Central Labs
2. Associated Labs
- public or private institutions, com reconhecida competência na realização e desenvolvimento de
métodos alternativos ao uso de animais de experimentação;
- it should contribute to the dissemination / development of alternative methods and offer its
laboratorial infrastructure to RENAMA
- an agreement for technical cooperation between the Central Labs and the Associated Lab is
necessary for joining RENAMA
All RENAMA laboratories should have R&D activities
Rede Nacional de Métodos Alternativos – RENAMA
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.
Rede Nacional de Métodos Alternativos – RENAMA
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.
Rede Nacional de Métodos Alternativos – RENAMA
2011
Organization and management
2011’s first rounf of funding to Central Labs for setting up an infrastructure to run the
following tests
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Citotoxicity in vitro (Guideline 129);
Bovine Corneal Opacity and Permeability Test - BCOP (Guideline 437);
Photo-cytotoxicity (Guideline 432);
Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Guideline 439);
Monocyte Activation Test (MAT);
Interlab assays
First round (2013-2014) to evaluate RENAMAFlux System and also a pilot for RENAMA Labs
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Citotoxicity in vitro (Guideline 129);
To establish the viability of RENAMAFlux System;
Identify gaps and issues that compromised the results qualityi;
Five labs enrolled
Rede Nacional de Métodos Alternativos – RENAMA
RENAMAFlux System
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One-stop-shop for interlab assays;
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Assure that raw data is automatically uploaded;
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Initiate GLP principles culture.
Rede Nacional de Métodos Alternativos – RENAMA
Recent Initiatives
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Call for proposals
First validation (HET-CAM)
Some ongoing projects
Associated Labs
Rede Nacional de Métodos Alternativos – RENAMA
i) Call for Proposals MCTI/CNPq - Nº 25/2012 - 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).
Rede Nacional de Métodos Alternativos – RENAMA
ii) Call for proposals (2014): In silico trials (LNBio)
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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
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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
Rede Nacional de Métodos Alternativos – RENAMA
2014’s projects
iii) 2014 – Funding of a validation study - HET-CAM - under RENAMA
iv) 2014 - Establishment of transgenic cell lines for in vitro assays
Rede Nacional de Métodos Alternativos – RENAMA
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.
Rede Nacional de Métodos Alternativos – RENAMA
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
Rede Nacional de Métodos Alternativos – RENAMA
Next steps
• International cooperation
• 2015-2016 actions
Rede Nacional de Métodos Alternativos – RENAMA
• International collaborations
– Joint Research Centre
• European Union Reference Laboratory for alternatives
to animal testing (EURL-ECVAM)
– MERCOSUL
• Regional Plattform
– NIH
• US-Brazil Collaborative Research Program
Rede Nacional de Métodos Alternativos – RENAMA
• 2015-2016 actions
– Human Resources Training
– 2nd call for proposals
• Congress Amendments
– Continuous flux for Associated Labs
Rede Nacional de Métodos Alternativos – RENAMA
Thank you!
[email protected]
[email protected]