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PPDC Work Group on 21st Century Toxicology/New Integrated Testing Strategies April 23, 2009 Teleconference/Meeting Minutes

List of Attendees:

The first item on the agenda was the issue of biomarkers of effect and exposure. The background to this issue was contained in the 2007 NAS report on Toxicity Testing in the 21st Century: a Vision and Strategy. The NAS envisioned that studies conducted in human cells would indicate how environmental agents could affect human biologic responses and that these studies would lead to the identification of useful biomarkers (e.g., indicators of human exposure, effect, or susceptibility) that could be used in population health surveillance and biomonitoring. As part of the workgroup objective a key transition activity includes identifying applications of this ‘new’ science in “..developing new diagnostic tools and biomarkers” and providing process recommendations to transition to the new testing paradigm. The work group was to consider two questions:

The workgroup agreed that it is important to include biomarkers as part of the vision for 21C toxicology outlined in the draft website. The work group suggested a tool matrix for biomarkers like the one developed for integrated testing tools. The first entry in the biomarker matrix would be the existing cholinesterase inhibitor test. A subgroup comprised of M. Keifer, J. Roberts, E. Janus, V. Dellarco, S. Bradbury, J. McLain, and M. Morgan will meet and begin developing the biomarker tool matrix before the May 20 meeting.

The workgroup also discussed ideas for future products to develop prior to the next PPDC meeting in the fall. Multiple ideas were discussed and we agreed on three to follow-up on in the near term.

  1. The work group is interested in developing a one-day FACA meeting as a way to communicate with a broader set of stakeholders on OPP’s transition to integrative testing and assessment.
  2. The work group also discussed forming a subgroup to develop measures to evaluate the success of the new toxicity testing paradigm.
  3. The work group also discussed forming a subgroup to develop a Questions & Answers document comprised of typical questions and concerns regarding integrative testing and assessment. For example, topics such as whether using cell lines would provide enough variability and whether there would be enough confidence in the results of in vitro tests for pregnancy issues.

Next Steps:

For the May 20 meeting, all members of the work group are encouraged to come prepared to discuss:

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