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Development of New Experimental Models for Identification of Potential Human Carcinogens

Background

The accuracy of extrapolating results from rodent studies to humans has often been questioned; in addition such studies are costly and time-consuming. It is envisaged that the new models would supplement and even replace the currently-used rodent bioassays and could be used for mechanistic studies leading to improved human risk characterisation.
Considerable effort is currently underway worldwide to develop and validate alternates to the two year bioassays utilising major advances in molecular biology. These tools are also contributing significantly to an increased understanding of the molecular basis of chemical carcinogenesis. Industry's participation and its support of this research is critical. Further industry's stakeholders (customers, consumers, workers and the community) would benefit from more accurate risk assessment methodologies.

Objectives

Proposals
Proposals submitted for consideration should follow the format of the application form'Application for a CEFIC-LRI Grant' and should address the following under individual headings:
The title of the research proposal
The name and affiliation of the principal investigator of the laboratory or laboratories in which the research will be conducted
Evidence of the principal investigator's expertise and contributions to the understanding of the mechanisms through which chemicals induce cancer in animals
A clear definition of the research objectives
A detailed plan of investigation, including a clearly defined milestone plan which identifies all critical decision points in the research programme
A detailed breakdown of costs.
Monitoring
The principal investigators will be required to submit a progress report annually during the course of the programme. At the end of the project a detailed review of the research and accomplishments made will be provided by the principal investigator. It is expected that the results will be published in a peer-reviewed journal; investigators are encouraged to present their preliminary findings in appropriate scientific meetings.

Scope

A rational scientific approach to the integration of recent advances in molecular biology into risk assessment should lead to more accurate and preferably shorter term assays. Therefore, research proposals should be based on the current and continuously growing knowledge in the molecular basis of the chemically-induced multistage carcinogenesis process.
The new methods, or combination of, should detect genotoxic and nongenotoxic carcinogens and provide information on their relative potencies. Ideally the new in vivo models will have the potential to become the methods of choice in species comparisons and dose-response studies.
In seeking proposals in the following areas, Industry will want to ensure that improved carcinogen risk assessment processes emerge:
Development and evaluation of improved transgenic rodent models that may ultimately replace the current 2-year carcinogenicity bioassay
Development of in vitro mammalian methods for the accurate identification of human carcinogenic potential. Such models should be relevant to target cells in vivo to facilitate the evaluation of key events in chemical carcinogenesis
Investigation of alterations in gene expressions as indicators of chemical carcinogenic potential and mechanisms of action.

Timing: between 3 - 5 years

Cost: Provide support to a qualified graduate student and/or post-doctoral fellow in research centres active in any of the above areas- US$ 30,000/year/graduate student, for up to 5 years;- US$ 50,000/year/post-doctoral fellow, for up to 3 years.2. Supplement ongoing research programmes- up to US$ 50,000/year, for years.3. Full research support on in vitro models or gene expression- US$ 200,000/year, for years.4. Full research support on in vivo models- US$ 200-500,000/year, 3 years

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