Synapse is the project manager for the IMI 2 five-year project, Enhancing Translational Safety Assessment through Integrative Knowledge Management (eTRANSAFE). The project officially started on September 1st 2017 while the official kick of will be in Barcelona (Spain) on the 26-27 of the same month. The project aims to develop an advanced data integration infrastructure together with innovative computational methods to improve the security in drug development process.
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 main specific objectives of the eTRANSAFE project are:
- The development of a state-of-the-art, powerful and flexible strategy and technological architecture for data sharing (diverse sources of nonclinical and clinical data), data integration and data exploitation.
- The implementation of the following key elements for this architecture: a specialised SEND (“standards for the exchange of non-clinical data”) data management system, a database of shared proprietary data managed by an honest broker, a Knowledge Hub providing seamless access to all the databases and data sources, and an ecosystem of data exploitation modules.
- The establishment of overarching policies and guidelines for safeguarded data sharing, secondary use of human safety data and use of pooled data and models in drug safety assessment.
- Optimising how preclinical studies are run and how the industry designs these studies.
Based on the experience gained in the previous eTOX project, in which Synapse was also the Project Manager, 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.
The eTRANSAFE consortium is formed by a private and public partnership of 8 academic institutions, 6 SMEs and 12 pharmaceutical companies which is coordinated by Ferran Sanz from the Fundació Institut Mar d’Investigacions Mèdiques (IMIM) and lead by François Pognan from Novartis Pharma AG. The project is co-coordinated by Carlos Diaz from Synapse, and Thomas Steger-Hartmann from Bayer AG., is the deputy leader.
The eTRANSAFE project is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).
For more information contact firstname.lastname@example.org, check out http://www.etransafe.eu/