Tox21 data analysis work group
With the availability of data generated in a multi-year US EPA ToxCastTM (ToxCast) and a federal collaborative program between US EPA, FDA, NIH, NTP at NIEHS called Toxicology in the 21st Century, or Tox21TM (Tox21) there is a need to address if and how this type of mechanistic data can be used in the risk assessment process of chemicals. EBTC has established a working group that is in the process of studying how the mechanistic data from ToxCast and Tox21 can be used in human safety assessment. The group is currently completing a systematic review of animal and human data on a number of approved drugs with and without drug-induced liver injury (DILI), as stated in the US FDA Liver Toxicity Knowledge Base. The observed adverse effect (AE) profile in experimental animals together with the AE profile as observed in patients in randomized controlled trials and post-marketing surveillance data (Real World Evidence) will be compared with the pathways signatures based on ToxCast and Tox21 data set.
Work Group members:
Hubert Dirven, Co-chair
Norwegian Institute of Public Health, Oslo, Norway
Thomas Hartung, Co-chair
Center for Alternatives to Animal Testing, Johns Hopkins School of Public Health
Integrated Risk Information System (IRIS) Division, US EPA, Research Triangle Park, NC, USA
Director of Science and Technology, Unilever, Bedford, UK
US EPA National Center for Computational Toxicology, Research Triangle Park, NC, USA
ToxStrategies, Austin, Texas, USA
Institute for In Vitro Sciences, Gaithersburg, MD, USA
Johns Hopkins Univeristy, Baltimore, MD
Douglas Connect GmbH, Basel, Switzerland
If you are interested in more information or to get involved, please contact us!