eTRANSAFE

Enhacing TRANslational SAFEty Assessment through Integrative Knowledge Management

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

Virtual control groups: shared, reused data could reduce animal use in drug safety studies

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

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EFPIA 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 Iris, 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 Forderung Der Angewandten Forschung Ev, 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
NameIHI funding in €
Certara Uk Limited260 938
Erasmus Universitair Medisch Centrum Rotterdam1 544 750
European Molecular Biology Laboratory840 032
Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev451 000
Fundacio Institut Hospital Del Mar D Investigacions Mediques1 997 259
Gmv Soluciones Globales Internet Sau803 854
Lhasa Limited2 930 750
Liverpool John Moores University528 875
Medbioinformatics Solutions SL390 000
Molecular Networks GMBH Computerchemie954 125
Optibrium Limited531 500
Pds Computer Software Limited613 375
Synapse Research Management Partners SL2 853 375
Universidad Pompeu Fabra1 754 500
Universitat Wien878 000
Universiteit Leiden1 535 325
 
Third parties
NameFunding in €
Barcelona Supercomputing Center-Centro Nacional De Supercomputacion489 952
Danmarks Tekniske Universitet642 391
 
Total Cost20 000 001