Topics discussed on today`s call

3.9.11 Conference Call for Systems Toxicology Pilot Study Participants from Battelle, FDA, Friends, Brookings, and the Reagan‐Udall Foundation discussed the general structure of a toxicology pilot study, topics for the study, and a plan of action for organizing the study. The ultimate goal of the study is to link microarray data of several chosen compounds with their physiological effects in order to begin to identify common mechanisms of toxicity. Potential topics for the study discussed include:  Cardiotoxicity of tyrosine‐kinase inhibitors (TKIs)  Cardiotoxicity of anthracyclines (as a control comparison to TKIs)  Cardiotoxicity of PARP inhibitors when used in combination with other agents. Ken Turteltaub will compile a list of review articles detailing the off‐target effects of some of these drug classes. Participants were encouraged to submit additional ideas for study topics. Participants also discussed a plan of action for organizing the pilot study. To focus and define the study more clearly, an in‐person workshop will first be held. Next Steps  Steering committee call week of March 14‐18 to begin to set up in‐person workshop: o Kenneth Turteltaub o Darrell Abernethy o John Leighton o Jeff Allen  Workshop mid‐late April to define project and develop concept paper for study o Could potentially be held at FDA White Oak Campus o This workshop would be 15‐20 people, including people on 3.9.11 call o ***Current work group members are asked to submit names and affiliations of additional potential participants*** o Suggestions from this call:  Yyves Lussier (U. Chicago Director of Bioinformatics)  Representative from National Center for Toxicological Research (NCTR)  Industry representatives (might want to get companies to share data)  The ultimate goal could be to move the project into Reagan‐Udall Foundation, which could help to identify sources of funding and support project management function of the pilot.