image: Olga Valverde, Ferran Sanz i Manuel Pastor, UPF professors involved in the coordination of the VICT3R project
Credit: Photo: UPF
Since this month of September, the Department of Medicine and Life Sciences (MELIS) at Pompeu Fabra University is coordinating the European project, VICT3R, which aims to replace test animals of control groups used in studies to evaluate the safety of drugs and other chemicals, with virtual controls. They will be created by reusing a large amount of data on control groups amassed over the years by the pharmaceutical industry, and the application of statistical methodology and artificial intelligence.
The project, financed with public and private funds and lasting three and a half years, will significantly contribute to achieving the objectives of the 3Rs of animal testing (reduce, refine and replace). By replacing control group animals with virtual counterparts, VICT3R aims to reduce the total number of animals required for preclinical drug safety studies by up to 25%.
The initiative is coordinated by Pompeu Fabra University as academic leader and Bayer AG (Berlin, Germany) as industrial leader. The project involves 33 public and private institutions, including 19 pharmaceutical companies that are sector leaders. In addition to UPF, other noteworthy participants are the Barcelona Supercomputing Center and the bioinformatics company MedBioinformatics Solutions, both based in Barcelona.
According to Ferran Sanz, a UPF full professor and academic coordinator of the project, “The reuse and sharing of data, as well as the application of new data science techniques, generate major opportunities to implement the 3Rs in the use of animals in preclinical experimentation”.
In the words of the industrial leader of the project, Thomas Steger-Hartmann, “The VICT3R consortium has the experience and capacity to change the regulatory paradigm in preclinical safety testing. By implementing virtual control groups, we can significantly reduce the use of animals, enabling both ethical value and economic benefits”. Therefore, the information generated will be accessible to consortium partners, regulatory agents and policy makers to demonstrate the validity of the virtual control concept.
VICT3R is part of the European public-private Innovative Health Initiative (IHI) that will distribute 13.5 million euros from the European Commission to public institutions, while pharmaceutical companies will contribute the remainder of the budget.
From preliminary results to an ambitious European project
The generation of virtual control animals was already prototyped during the eTRANSAFE project, also coordinated by Ferran Sanz.
The results obtained in the preliminary studies suggest that virtual animals could be a good tool in preclinical studies evaluating the safety of drugs. However, the methodology for applying this concept still requires refinement so that the virtual controls will maintain the highest standards of scientific practice and can be used for the regulatory evaluation of new medicines.
“Although in many cases we will generate the virtual controls using historical data of real animals in other cases this will not be possible, due, for example, to the limited availability of data on certain species or experimental conditions. In such cases, generative methods of artificial intelligence can be of help, producing completely synthetic virtual animals. In this process, machine learning methods will also be applied to complete the knowledge compiled in the databases for obtaining virtual controls”, explains the UPF professor, Manuel Pastor, who will be in charge of applying artificial intelligence techniques.
The VICT3R project also seeks to extend the concept of virtual control groups to other types of toxicological and pharmacological studies that are carried out using test animals, both in industrial and academic environments. Professor Olga Valverde from UPF is to co-lead this part of the project.