Summary
Assessing the safety of potential medicines remains immensely challenging. One major difficulty is understanding how well toxicity in animal tests predicts toxicity in humans. A lot of data on toxicity exists, but it is scattered across diverse public and private sources and stored in different formats.
The goal of the eTRANSAFE project is to develop a powerful data integration infrastructure (the Knowledge Hub) and use this as the basis for computer-based tools for use in drug development. The infrastructure would be flexible and expandable, and would draw on the latest technologies to deliver advanced solutions for data sharing, interoperability and exploitation. An ‘honest broker’ will ensure that confidential data would remain confidential, and overarching policies and guidelines will address ethical and legal issues such as the secondary use of human data. A large part of the project will be devoted to the creation of in silico (computer-based) tools for data mining and visualisation and, crucially, the prediction of potential toxicity.
The project outputs will increase the efficiency of preclinical toxicity studies, most notably in the pharmaceutical industry, and this in turn will help to speed up drug development. In addition, as the tools are computer-based, their use will contribute to a reduction in the use of animals in research. Finally, the project will contribute to the FAIR (‘findable, accessible, interoperable, re-useable) data principles.
Achievements & News
July 2023
The app, developed by IMI project eTRANSAFE, makes it easier for researchers to analyse which biomarkers are being used in...
Before drugs can be tested in humans, medicines regulators require companies to assess the safety of a drug candidate in animal studies. Some animals are administered the compound that is being investigated at different doses, while another animal group is used as control, meaning they don't receive the drug candidate. These control groups have generated a lot of data, and IMI’s eTRANSAFE is deploying computer wizardry to bring this data together and use it to better understand and predict drug safety, resulting in safer drugs while reducing the number of animals used in research, part of a wider trend in biomedical research (see the 3Rs).###
Specifically, they want to create ‘virtual control groups’ that could replace real ones in future studies. Since in a usual animal study, 25% of the animals are used as controls, the suggested approach has the potential to reduce the number of animals needed by a quarter. In the coming months, a proof-of-concept will be carried out using as many as 500 studies identified by the eTRANSAFE pharma partners. They will take already completed studies, replace the original control group with the virtual control group, and compare the findings. If the results are promising, the project will request a meeting with the European Medicines Agency to assess whether the virtual control group concept could satisfy the requirements for animal toxicology studies.
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Participants
Show participants on mapEFPIA companies
- Abbvie Inc, North Chicago, Illinois, United States
- Astrazeneca AB, Södertälje, Sweden
- Basf Se, Ludwigshafen Am Rhein, Germany
- Bayer Aktiengesellschaft, Leverkusen, Germany
- Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
- Eisai Co LTD, Bunkyo Ku Tokyo, Japan
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Institut De Recherches Internationales Servier, Suresnes, France
- Ipsen Innovation SAS, Les Ulis, France
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Sanofi-Aventis Deutschland GMBH, Frankfurt / Main, Germany
Universities, research organisations, public bodies, non-profit groups
- Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
- European Molecular Biology Laboratory, Heidelberg, Germany
- Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., München, Germany
- Fundacio Institut Hospital Del Mar D Investigacions Mediques, Barcelona, Spain
- Liverpool John Moores University, Liverpool, United Kingdom
- Universidad Pompeu Fabra, Barcelona, Spain
- Universitat Wien, Vienna, Austria
- Universiteit Leiden, Leiden, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Certara Uk Limited, London, United Kingdom
- Gmv Soluciones Globales Internet Sau, Tres Cantos, Spain
- Lhasa Limited, Leeds, United Kingdom
- Medbioinformatics Solutions SL, Barcelona, Spain
- Molecular Networks GMBH Computerchemie, Erlangen, Germany
- Optibrium Limited, Cambridge, United Kingdom
- Pds Computer Software Limited, Leicester, United Kingdom
- Synapse Research Management Partners SL, Barcelona, Spain
Third parties
- Barcelona Supercomputing Center Centro Nacional De Supercomputacion, Barcelona, Spain
- Danmarks Tekniske Universitet, Kgs. Lyngby, Denmark
Participants | |
---|---|
Name | EU funding in € |
Certara Uk Limited | 260 938 |
Erasmus Universitair Medisch Centrum Rotterdam | 1 544 750 |
European Molecular Biology Laboratory | 1 010 032 |
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | 451 000 |
Fundacio Institut Hospital Del Mar D Investigacions Mediques | 1 884 759 |
Gmv Soluciones Globales Internet Sau | 863 854 |
Lhasa Limited | 2 930 750 |
Liverpool John Moores University | 528 875 |
Medbioinformatics Solutions SL | 390 000 |
Molecular Networks GMBH Computerchemie | 954 125 |
Optibrium Limited | 531 500 |
Pds Computer Software Limited | 553 375 |
Synapse Research Management Partners SL | 2 853 375 |
Universidad Pompeu Fabra | 1 754 500 |
Universitat Wien | 878 000 |
Universiteit Leiden | 1 647 825 |
Third parties | |
Name | Funding in € |
Barcelona Supercomputing Center Centro Nacional De Supercomputacion | 546 202 |
Danmarks Tekniske Universitet | 416 141 |
Total Cost | 20 000 001 |