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Evidence-Based Toxicology Collaboration

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 

Kris Thayer
Integrated Risk Information System (IRIS) Division, US EPA, Research Triangle Park, NC, USA

Carl Westmoreland
Director of Science and Technology, Unilever, Bedford, UK

Richard Judson
US EPA National Center for Computational Toxicology, Research Triangle Park, NC, USA

Daniele Wikoff
ToxStrategies, Austin, Texas, USA

Rodger Curren
Institute for In Vitro Sciences, Gaithersburg, MD, USA

Rob Wright
Johns Hopkins Univeristy, Baltimore, MD

Maja Branjnik
Douglas Connect GmbH, Basel, Switzerland

If you are interested in more information or to get involved, please contact us!