Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity Testing: Project Committee/Subgroup Meetings

Meeting Schedule

• Monday, March 22 (9:30 AM - 5:30 PM): Quantitative Subgroup - Dose-Response Modeling, Project Objectives
• Tuesday, March 23 (8:30 AM - 5:30 PM): Quantitative Subgroup – Pig-a Validation / Statistics, Database Overview, Data Gaps
• Wednesday, March 24 (8:30 AM - 12:30 PM): Quantitative Subgroup – Project Plan
• Wednesday, March 24 (1:30 PM - 5:00 PM): IVGT Project Committee Business Meeting (all sponsors)
• Wednesday, March 24 (6:00 - 7:30 PM): dinner reception
• Thursday, March 25 (8:30 AM - 5:30 PM): Improving Existing Assays Subgroup
• Friday, March 26 (8:30 AM - 12:00 PM): New Approaches Subgroup
• Friday, March 26 (1:00 - 5:00 PM): Genotoxicity of Nanoparticles

Project Descriptions

I. Quantitative Subgroup

The Quantitative Subgroup will be the focus of the IVGT in 2010 and beyond. This Subgroup also has several smaller groups, to assist in the objective of gathering/analyzing dose-response data to support the decision tree. This includes a collaborative project with Health Canada, development of a relational database to house dose-response genetic toxicology data, and a Pig-a Interest Group to provide dose-response data for that endpoint.

II. Improving Existing Assays Subgroup

The Improving Existing Assays Subgroup is new for 2010, and has the following short-term goals: 1) evaluate the reduction of the maximum concentration tested in in vitro mammalian cell tests, and 2) to confirm identity and quality of cell lines commonly utilized in genotoxicity testing. These objectives were identified as “needs” by the IWGT this past summer. This was discussed at an IVGT meeting held in Basel, Switzerland on August 19, 2009.

III. New Approaches Subgroup

The objective of this new Subgroup for 2010 is to plan and execute a 2nd IVGT Workshop: “Adoption of alternative in vitro/ex vivo models for genetic toxicity testing.” This was discussed at an IVGT meeting held in Basel, Switzerland on August 19, 2009. This objective was discussed in the context of the New/Emerging Technologies Working Group fulfilling its original objective upon publication of the May 2008 workshop proceedings. The formation of a new Subgroup to evaluate alternative models outside the usual realm of models used for genotoxicity assessment was thought necessary since the New/Emerging Technologies Working Group will be sunset.

IV. Genotoxicity of Nanomaterials/Nanoparticles

This potential project is currently being surveyed among IVGT sponsors. Please return the previously distributed survey if you have not yet done so. Recently, sponsors of the HESI Immunotoxicology Technical Committee (ITC) have expressed interest in a potential workshop on the immunotoxicity of nanomaterials/nanoparticles, since the HESI Technical Committee on the Safety of Nanomaterials was sunsetted in 2009. One suggestion is to host a joint workshop (IVGT and ITC) on the genotoxicity and the immunotoxicity of nanomaterials/nanoparticles. If the IVGT and ITC decide that such a workshop falls outside the scope of these committees, the workshop might be pursued as a “Resources at Initiation” (RAI) project, whereby funding for the workshop could be provided by the committees and by interested parties. The workshop then would be outside the purview of the IVGT and ITC, and would directly engage those parties specifically interested in the workshop.

Click here to access a draft meeting agenda.