The five-year eTRANSAFE project is funded by the Innovative Medicines Initiative 2 Joint Undertaking (IMI 2) together with the pharmaceutical industry.
The eTRANSAFE consortium is a private and public partnership of 8 academic institutions, 6 SMEs and 12 pharmaceutical companies, and is coordinated by the Fundació Institut Mar d'Investigacions Mèdiques (IMIM) and led by the pharmaceutical company Novartis.
"The safety of new drug candidates in first clinical trials is extrapolated based on preclinical animal data. These extrapolations are made using solely the data generated for the project at hand, since a global and systematic analysis of predictivity of the entire collective historical data pool has never been made", stated Project leader Francois Pognan from Novartis. "It is often poorly known to what extent and frequency an observed effect in an animal species may translate into a human effect", added deputy leader Thomas Steger-Hartmann from Bayer.
Based on the experience gained in the previous eTOX project, the eTRANSAFE project will carry out key efforts in the field of data standardisation and quality control, promoting the development and implementation of relevant data sharing policies and procedures that will have a great global impact in the community. eTRANSAFE will catalyse the transformation of drug safety modelling from monolithic applications and isolated data repositories to an open innovation ecosystem based on open standards, modular components and data integration services.
Professor Ferran Sanz, coordinator of the project, stated: "eTRANSAFE will improve translational safety assessment and contribute to the key scientific policies, such as the reduce, reuse, recycle (3Rs) one and the FAIR principles for data sharing."
The main specific objectives of the eTRANSAFE project are:
The project is coordinated and led by Fundació Institut Mar d'Investigacions Mèdiques (Coordinator); Novartis Pharma AG (Leader); Synapse Research Management Partners SL (Co-coordinator); and Bayer AG (Deputy Leader).
The eTRANSAFE partners are:
eTRANSAFE is funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. eTRANSAFE has received support from IMI2 Joint Undertaking under Grant Agreement No. 777365. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe.
For more information you can visit the eTRANSAFE project website.