40 Million EUR European project for new drug safety assessment and integrative data analysis research.

40 Million EUR European project for new drug safety assessment and integrative data analysis research.

The project Enhancing Translational Safety Assessment through Integrative Knowledge Management will last 5 years and will be funded with European funds and the pharmaceutical industry. Ferran Sanz and Manuel Pastor, principal investigators at Pompeu Fabra University, will take part in it.


eTRANSAFEThe five-year project, Enhancing Translational Safety Assessment through Integrative Knowledge Management (eTRANSAFE), aims to develop an advanced data integration infrastructure together with innovative computational methods to improve the security in drug development process and 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. The Institut Hospital del Mar d'Investigacions Mèdiques (IMIM) is the academic coordinator of the project and the pharmaceutical companies Novartis and Bayer AG are the industrial coordinators.

The eTRANSAFE project aims at improving the safety assessment across the drug discovery and development process by applying bioinformatics approaches to shared preclinical and clinical data to systematically analyse the translatability of effects. Thus, enabling the optimisation of resources and the development of safer medicines.

“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", said 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”, adds deputy leader Thomas Steger-Hartmann from Bayer.

In this sense, the group of Integrated Biomedical Computing of IMIM led by Laura Furlong will participate in activities of data integration, translational analysis and discovery of security biomarkers and Manuel Pastor, leader of the UPF's PharmacoInformatics group, will coordinate work groups in predictive modeling and software development.

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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.

Ferran Sanz, coordinator of the project and professor at Pompeu Fabra University, said: “eTRANSAFE will improve translational safety assessment and contribute to the key scientific policies, such as the reduce, replace, refine (3Rs) one and the FAIR principles for data sharing.” 

For more information about eTRANSAFE project please visit:

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.