In its third year activity the EU-funded InSilc project is producing very promising results by creating an in silico clinical trials platform for designing and developing drug eluting Bioresorbable Vascular Scaffolds (BVS).
InSilc goes beyond the design and development of ISCT and lays on the generation of in-silico models that can be used to obtain quick and informed answers to several “What if” scenarios. This opens the door to a whole new concept of personalized medicine enabling the consolidation of multidisciplinary efforts (computational modelling, materials science and engineering, systems biology).
InSilc is expected to transform the Stent Biomedical Industry, by including all available physiological and biological knowledge and by capturing the features of individual patients, while in parallel introduce the concept of the patient-specific model InSilc will enable the simulation of a number of patient-specific factors and take into account the variability among individuals, which affects the outcomes of the candidate drug-eluting BVS implantation. “Virtual” patients would be given a “virtual” drug-eluting BVS, allowing observations, through computational simulations, the performance of the scaffold, assess and quantify the intended effect, with a much deep understanding than normal trials can provide, without inducing adverse effects and undesirable clinical outcomes, that might be potentially dangerous for the patient.
In the first three years of the projects, the consortium focused their efforts on the smooth implementation of the modelling tasks and the association of the corresponding workflows and results with consistent use-case scenarios and the clinical study design, respectively. In particular, they have started elaborating on the project’s primary objective which is the partial replacement of stent animal and clinical studies by tailored in silico trials. Following some initial discussions with relevant stakeholders, the InSilc consortium established an initial set of “scenarios” upon which the technical workflows and their integration are designed. InSilc is targeting the whole process of the BVS development chain, starting with the pre-clinical testing and the animal testing and next with the real clinical trials. Five different scenarios of use have been developed so far, each of which is focusing on different development phases.
The existence of an inclusive “virtual” population is considered essential for the development of InSilc in silico platform. So far, retrospective clinical data were collected to support the creation of “virtual population”. A prospective proof-of-concept study is also in progress in two countries, Greece and Netherlands.
The project has recently released a preview of their web-based 3D viewer that will be used for pre- and post-processing of In Silico Clinical Trials. The link to the video can be found here
For more information on the project, visit their website