InnovaHeart 2024, the European workshop on the digital heart, will take place on 6-7 February in Leuven, Belgium, at the KU Leuven university, with the aim of gathering cardiovascular modelling experts from academia, industry, regulatory and notified bodies to discuss advancements, challenges, and outstanding issues in the field of in-silico modelling in cardiovascular medicine.
The event represent a join effort of SIMCor, SimInSitu, SimCardioTest Horizon 2020 Research and Innovation Actions as part of the SC1-DTH-06-2020 (Accelerating the uptake of computer simulations for testing medicines and medical devices) cluster, the EDITH Horizon Europe Coordination and Support Action, and the inEurHeart EIT Health innovation project.
During the first edition of the workshop, held in Bordeaux in March 2023 under the lead of INRIA and the SimCardioTest, a recurring topic emerged: the persistent obstacles preventing the successful translation of in-silico models into clinical application. Even with the significant enhancement in the quality, fidelity, and usability of these models in cardiovascular medicine, their transition to clinical settings remains infrequent.
The 2nd edition of InnovaHeart will thus focus on the challenges of efficiently transitioning in-silico models from a research environment to practical clinical applications. We will start by allowing the industry first to discuss the current problems and how in-silico models can potentially support them. Then, the workshop will pass through the presentation of clinical trial design and execution, inclusive of their distinct requirements and regulatory considerations, and the concept of in-silico clinical trials, along with its advantages and limitations. The complexities pertaining to the legislative and regulatory facets of in-silico clinical trials will also be addressed, as well as potential synergies between traditional and in-silico trials. To establish in-silico trials in the future, it is imperative to also discuss how to generate and assess the credibility of in-silico models, as well as to understand the predictive capability of the model validation results as we approach the limits of the validation space. Finally, we will highlight success stories of in-silico clinical trials, offering insights from specialists from industry and regulatory bodies.
Building on this knowledge, a series of working groups on key open challenges and recent topics will be held, giving the opportunity to delve deeper into specific barriers in the translation process. Areas of discussion will encompass inter alia: regulatory validation needs and strategies, the process of securing funding and approval for prospective studies, the translation of in-silico trial outcome metrics into meaningful endpoints for clinical evaluation, the credibility of in-silico models and the predictive capability of the validation results. Moreover, these working groups will also serve the purpose of mapping out the current progress in academic and industrial research. The resulting outcomes will be shared with the community, serving as a foundation for advancing research and innovation in the field.