CRACK IT Mega-Challenge: towards a virtual second species in toxicology for drug development

Funding of up to £3.9 million is available through the 2021 NC3Rs CRACK IT Challenges competition (which is being run as an SBRI) for UK and EU-based academics and SMEs to develop 3Rs products and services directly targeted to meet end-user needs.

2021 Challenges

The 2021 competition includes two Challenges which cover key areas of animal use in toxicology and environmental risk assessment. Challenges are developed in collaboration with Sponsors who provide in-kind contributions to help solve the Challenge, with the aim of using any product or service developed. Challenges are supported by Partners who provide additional resources such as access to data, end-user networks and regulatory expertise to Challenge winners.

Our first Mega-Challenge represents a leap forward in the size of the problem a Challenge addresses and supports this with increased funding and award duration. The Mega-Challenge is a first for the NC3Rs and in 2021, marks ten years since launching the CRACK IT Challenges programme.

Click here for details of Challenge 41 – SAFE: Innovative Safety Assessment of Fish adverse Effects.

Challenge 40 – Second Species Mega-Challenge: towards a virtual second species in toxicology for drug development  

Current regulatory guidelines for medicines usually require safety and tolerability data from two species, a rodent and a non-rodent (e.g. dog). Advances in mathematical modelling, data interrogation and the availability of historical and contemporary dog study data, provide opportunities to develop a virtual dog to model potential toxicities and move towards use of a single (rodent) species for chronic toxicology studies.

This Challenge aims to apply advanced computational and mathematical modelling approaches including Machine Learning, systems biology, systems toxicology and multi-scale modelling to develop a suite of virtual dog tissues and organs to model toxicological endpoints for new medicines. The model developed will provide a tool to start moving towards replacing the use of the dog as a second species in drug development.

The Challenge is sponsored by Bayer AG, Eli Lilly and Company, Genentech Inc., Gilead Sciences Inc., GSK, Merck Healthcare KGaA and Roche, with co-funding from the EPSRC and supported by Challenge Partners eTransafe – Innovative Medicines Initiative (IMI) and Simomics.

3Rs benefits: A typical chronic toxicity study uses 40 dogs and development of a virtual model could reduce or eliminate the need for chronic toxicity studies in the dog during drug development and provide the foundation to develop further in silico models for other test species.