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Open innovation to improve drug safety

A decade ago, the European Union and the European Federation of Pharmaceutical Industries and Associations promoted the creation of the Innovative Medicines Initiative, with the aim of developing increasingly efficacious and safe drugs. Financing first came from the Seventh Framework Program of the European Union, and later from the Horizon 2020 Framework Program. Given the ever-rising cost of researching and developing new drugs, IMI aims to reduce the number of negative outcomes in the initial development stages, which would reduce the overall costs and accelerate the search for new therapies.

One of the lines of action carried out by IMI is the eTOX project, financed through the Innovative Medicines Initiative Joint Undertaking (IMI-JU). This initiative belongs to the area of open innovation, through which public sector and private industry actors actively cooperate to share data and knowledge of the toxicological evaluations of experimental drugs. The results of eTOX, which has recently created databases to streamline the transfer of research outcomes to companies, and the generation of sustainable results that can be used once the different studies conclude, were recently presented in an article published in the journal Nature Reviews Drug Discovery.

As the authors of the study point out, the exchange of preclinical safety data among pharmaceutical companies and their integration with other sources offers “unprecedented opportunities” to improve the early toxicological evaluation of the drugs. Ferran Sanz, director of the Research Programme on Biomedical Informatics (GRIB) of the Hospital del Mar Medical Research Institute and of Pompeu Fabra University, states that “The eTOX project has given us a glimpse into the potential of this data for constructing predictive models capable of foreseeing effects in vivo. However, it is necessary to incorporate toxicodynamic effects and analyse the extent to which the experimental data and predictions can be extrapolated to humans.”

Medicine capsules and tablets
Source: Pixabay

Having formed part of the project at IMIM, the Hospital del Mar Medical Research Institute, as its academic coordinator, he has now launched the eTRANSAFE initiative, which aims to continue the work of eTOX with the support of the pharmaceutical industry. Multinational corporations Novartis and Bayer AG are the industrial leaders of this project, backed with financing of 40 million euros, and participated in by twelve pharmaceutical companies, six SME’s and eight academic institutions. The project aims to improve safety assessment across all phases of the drug research and development process by “applying bioinformatics approaches to shared preclinical and clinical data to systematically analyse the translatability of the effects observed in experimental models into the clinical realm,” states Sanz.

 

Generally, when a new experimental drug is studied, the data gathered during the preclinical phase are extrapolated for the initial clinical trials. “These extrapolations are made using solely the data generated for the project at hand, since a global and systematic analysis of safety predictivity of the entire collective historical data pool has never been made,” say Francois Pognan of Novartis and Thomas Steger-Hartmann of Bayer AG. The goal of eTRANSAFE, based on the positive results gained in eTOX, is to advance in the integration of data and information to progress in “translational safety”, optimize the development of preclinical studies and promote the policies that seek to reduce, replace and refine the use of experimental animal models in this type of trials.