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General Information


Summary & Objectives


Background & Concept


Potential Impact of Project Results


Project Activities


ETOX Project line

ETOX Project


ETOX Project


ETOX Project


ETOX Project



Potential Impact of Project Results


Socio-economics Impacts


Currently, the safety aspects of drug development are addressed by running numerous, legally defined animal studies. These studies, using many laboratory animals ranging from rat to dog and monkey, are time consuming and are performed before and in parallel to human clinical studies. Toxicological and pharmacokinetics observations in animal studies are interpreted and extrapolated to human, which decide on start and continuation of clinical studies with the ultimate goal of providing new, more efficacious drugs to the human population. The discovery of unexpected or unacceptable toxicological side effects can either greatly delay the development of new drugs or even stop it altogether, wasting years of research, vast amount of resources, time and money. This is even more dramatic when the New Chemical Entity (NCE) is intended for very serious diseases with poor or even no current treatment.


The endeavour of this project is very ambitious, has never been done before and has the potential to contribute largely to reduce the number of necessary animals studies, the duration of the preclinical testing phase and ultimately to improve attrition rate. This consortium intends to build a large database that brings together public data and EFPIA legacy data, which have never been integrated before. There is a wealth of toxicological data in pharmaceutical companies which so far is not exploited. Here, by using all these data and developing relevant algorithms and exploitation software, the possibility of predicting, or at least of defining the probability, of a chemical structure to be noxious on a specific organ should become possible. Hence, considering that from discovery to market, the development of a new drug takes about 10 years and costs about a billion Euros, finding early potential toxicity issues of NCEs would have the following impacts:



  • Allow to modify early in discovery the chemical backbone of molecules to keep the pharmacology and other desirable parameters such as solubility, distribution, etc. and remove the unwanted side effects.

  • Bring into animal studies only those chemicals which would have been optimised as much as possible for their safety, overall reducing the number of animals used for drug development.

  • Increase the success rate of NCEs to become new drugs (reduction of the attrition rate).

  • Reduce the overall cost of new drug development, allowing pharmaceutical companies to allocate more money to a wider range of disease areas.

  • Reduce overall the risk of human side effects once new drugs are on the market.

  • Improve the quality of life for patients by making safer drugs (less adverse drug reactions) available to them, more rapidly.



Furthermore, by analysing this integrated vast amount of data, it is possible that new candidate biomarkers of toxicity will emerge. Biomarkers of toxicity have their own impact on drug development, by allowing monitoring in pre-clinical and clinical studies the emergence and evolution of an untoward side effect. Such biomarkers allow to initiate human studies even in the presence of observed animal toxicity and to stop the trial if needed before any health consequences for the patients exist. This permits the progress of proof of concept studies for human efficacy and finally in some cases, the full development of drugs which otherwise would have been stopped.


Overall, this project, if successful, has the potential to bring drug development into a new era, where the likelihood of a new chemical structure to display toxic features would be predicted in advance and therefore, provide time to remedy such drawbacks before animal studies and clinical studies are undertaken. There is an obvious money and time saving advantage for the pharmaceutical industry, increasing its competitiveness, but other advantages include the exploitation of data into knowledge for global scientific progress and, ultimately, an improvement of the world pharmacopoeia for the benefit of the human society as a whole. Additionally, the system to be developed may also be applied for the assessment of impurities or synthesis intermediates thus improving the knowledge of these compounds without additional animal testing. More generally, as the project intends to facilitate access to the eTOX results by the broader scientific community, it can be expected to also enforce new scientific advances and knowledge creation in the field.



Reaching these goals



The main deliverables of this project will be the constitution of a very large (likely the world’s largest) pharmaco-toxicological database and the associated exploration software and algorithms. The data collection will mainly be performed by the EFPIA partners on the basis of legacy toxicology reports and will be done as an in-kind contribution to the project, i.e. these activities won’t be funded by the IMI-JU. This database will be accessible by the scientific community, of academic or industrial (biotechnological or pharmaceutical) nature, while technical provisions will be implemented to protect intellectual property of each contributing partner. The database will be hosted and maintained by an “honest broker” and new data will be implemented beyond the 5-year project plan. Hence, by adding new data regularly, the predictive power of the system should evolve permanently, along with the scientific knowledge as a whole.


The simple fact that this database will contain pharmaceutical proprietary data not yet accessible by anyone but the respective owners, grouped together in one place with public data, and made available to the overall scientific community, constitutes a major goal and breakthrough.


The Steering Committee, consisting of the representatives of each project partner will develop an internal and external communication plan adapted to the project progress and the availability of the deliverables. Pillars of such a communication plan will be scientific and non-scientific publications, as well as presentations on eTOX in international conferences (e.g. annual Eurotox meetings). In addition to that, the Steering Committee will develop and use additional tools to disseminate project results among the scientific community and other stakeholders of IMI. Such tools may comprise of video-/webconferences, an eTOX webpage, media and press releases.




Cooperation with regulatory bodies



In order to be successful it is of importance for this project that regulatory authorities such as EMEA are aware of the progress and orientation of the various tasks foreseen in the project. Therefore, it has been decided that the Executive Committee of eTOX will seek the advice and guidance of the relevant EMEA body.