CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN (CHA)Coordinator
Extended over 4 campuses and 17 clinical centres, CHA is one of the largest university hospitals in Europe, which is internationally renowned for its excellence in clinical care, teaching and training. At CHA, approximately 3,700 researchers are actively engaged in the development of pioneering innovations in the field of medicine across 1,000 projects, working groups and national as well as international collaborative projects for the benefit of clinicians, patients, and society.
As coordinating institution, CHA is responsible for project scientific and clinical supervision, besides leading the processing of imaging and sensor data from bench tests, preclinical and clinical studies as input for the generation of virtual cohorts and simulation modelling. CHA will also carry out preclinical tests as well as simulations and validations of blood flow modelling for PAPS, in cooperation with BIO.
Lynkeus is an independent research and consultancy firm specialized in the design and implementation of advanced IT solutions in healthcare and the biomedical sciences. Its team of IT and biomedical scientists, lawyers and experts in public administration delivers GDPR-compliant and scalable medical data sharing systems leveraging privacy-preserving solutions from blockchain to synthetic data. Founded in 2000, Lynkeus develops solutions at the intersection of ethics, law and medical technologies.
Lynkeus is supporting the Coordinator as Project Manager and is chief responsible of scientific communication, dissemination and exploitation of project results. LYN is also conducting the assessment of data management procedures for privacy, security and GDPR compliance and will contribute to the conception of operating procedures and guidelines.
Founded in 1963, Biotronik is a leading global medical device company with products and services that save and improve the lives of patients suffering from cardiovascular and endovascular diseases, ranging from cardiac rhythm management, electrophysiology to vascular intervention solutions. Key products include pacemakers, implantable defibrillators and leads, external remote monitoring systems for patients with cardiac arrhythmias, catheters, stents, balloon catheters and guide wires.
Biotronik will be the project lead responsible for computer simulations for the evaluation of device safety, efficacy and usability. It will also contribute to the development of device models, modelling of vessel-device interaction during and after device implantation, validation of modelling tools and will support the approval of in-silico testing strategies by regulatory authorities.
EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)
ECRIN is a sustainable, not-for profit, distributed European Research Infrastructure Consortium that provides support for the planning and implementation of multinational clinical research projects in Europe. ECRIN includes a Core Team based in Paris, France and European Correspondents working in each of its 12 Member and Observer Countries hosted by the national scientific partners/networks of academic clinical trial units.
ECRIN will be responsible for assessing and quantifying the benefits of the use of in-silico solutions on clinical trials and the healthcare sector at large. It will evaluate the potential reduction in the size and duration of human trials and the use of animal testing, as well as in terms of enhanced device testing efficacy and reliability, improved patient outcomes and reduced adverse events.
INSTITUTE FÜR HÖHERE STUDIEN – INSTITUTE FOR ADVANCED STUDIES (IHS)
IHS is an independent, non-profit research institute that brings together high-level expertise from various disciplines (economics, sociology and political science among others) to address fundamental economic and social problems and policy choices. Through the combination of basic academic research, applied research and policy advice on topics such as health, labour market, European integration, and education under one roof it has a unique position in the Austrian scientific landscape.
IHS will lead the assessment and quantification of healthcare, industrial and socioeconomic impacts. Specifically, it will conduct analyses on the impact of using virtual cohorts on the industry and market on the one hand, and the healthcare system and society as a whole on the other, through the analysis of literature, interviews and project-generated data.
INSTITUT FÜR IMPLANTAT TECHNOLOGIE UND BIOMATERIALIEN E.V. (IIB)
The IIB was founded in 1996 and is an affiliated institute of the University of Rostock in the legal form of a non-university, non-profit institute. The institute focuses on basic and industrial research in the fields of biomaterial testing, implant development, biomechanics and sensor technology, especially on cardiovascular implants such as vascular stents, transcatheter valve prostheses and other transcatheter-based implant technologies. Prof. Schmitz, director and founder of the IIB e.V., is member of the German Academy of Science and Engineering.
IIB will develop and optimise device-specific in-silico models predicting transcatheter aortic valve prosthesis performance related to safety, efficacy and usability, focussing on risk of thrombosis, leakage rate and durability, through bench tests and virtual cohorts. Additionally, IIB will take part in the developing of standard operating procedures.
PHILIPS ELECTRONICS NETHERLANDS B.V. (PHI)
PHI is a leading health technology company focused on improving people’s health and enabling better outcomes from healthy living and prevention to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.
PHI will lead the virtual device implantation activity, that will develop 3D high-fidelity and reduced order finite element models to describe the device and its interaction with the recipient’s tissue. It will also support the development of virtual cohorts and simulation of device effects, and the development of standard operating procedures.
EINDHOVEN UNIVERSITY OF TECHNOLOGY (TUE)
TUE is a research university specialised in engineering, science and technology. With over 11,000 students, 2,000 research staff and 1,500 PhD students, TU/e is one of the largest universities in Europe and includes a Department of Biomedical Engineering with a dedicated undergraduate and graduate program. Here, the Cardiovascular Biomechanics group focuses on numerical and experimental modelling of the cardiovascular system to develop diagnostic methods, model-based decision support systems and therapeutic protocols.
The main role of TUE is the development and validation of virtual cohorts for TAVI and PAPS simulation for in-silico clinical trials, based on image, sensor and laboratory patient data from aortic valve stenosis and heart failure, as well as a small virtual cohort of animals for in-silico preclinical studies. TUE will also contribute to virtual device implantation, device and device tissue interaction modelling.
GRAZ UNIVERSITY OF TECHNOLOGY (TU Graz)
The quality of the education and training at TU Graz is due to its knowledge-oriented and applied research. TU Graz has over 2.000 staff, 12.000 undergraduate and 1.180 PhD students, and a Biomedical Engineering program with around 200 new students every year. BioTechMed-Graz, a cooperation and networking initiative between the University of Graz, the Medical University of Graz and Graz University of Technology, works at the interface of biomedical basics, technological developments and medical implementation.
TU Graz will lead the development of constitutive models for the deployment of devices in the cardiovascular system and the simulation of device-specific effects in regard to safety, efficacy and usability. Particularly, TU Graz will study the structure of the vessel wall, develop and validate sophisticated models describing its material behaviour and incorporating tissue-device interaction effects.
UNIVERSITATEA TRANSILVANIA DIN BRASOV (UTBV)
UTBV is a public academic institution with over 800 full-time scientists and professors and around 20,000 undergraduate and PhD students. The University has 16 faculties, eight of which focused on engineering areas. The Department of Automation and Information Technology, within the Faculty of Electrical Engineering and Computer Sciences, has carried out numerous biomedical engineering research projects at national and EU level, with a strong know-how in mathematical and machine-learning based modelling and cloud computing.
UTBV is responsible for the implementation of the virtual research environment of the SIMCor research platform, supporting data collection and sharing, virtual cohort validation, execution of device effect simulations and virtual clinical trials, and contributing to the European Open Science Cloud. UTBV will also contribute to virtual patient cohort generation, device modelling and validation.
UNIVERSITY COLLEGE OF LONDON (UCL)
UCL is London’s leading multidisciplinary university, with more than 13,000 staff and 38,000 students from 150 different countries. UCL has a global reputation for excellence in research and is committed to delivering impact and innovations that enhance the lives of people in the UK, across Europe and around the world. UCL was identified by the UK Research Excellence Framework as the top university in the UK for research strength and UCL is consistently placed in the global top 20 across a wide range of university rankings (currently joint 7th in the QS World University Ranking).
UCL will bring clinical and modelling expertise to the project, leading data acquisition for TAVI and PAPS population, reviewing and reporting retrospective data quality and creating synthetic data. Also, UCL will contribute to the processing imaging data and creation of anatomical models and boundary conditions for the simulations, as well as the definition of standards of practice.
VIRTUAL PHYSIOLOGICAL HUMAN INSTITUTE FOR INTEGRATIVE BIOMEDICAL RESEARCH VZW (VPHi)
VPHi is an international non-profit organisation whose mission is to ensure that the in-silico medicine paradigm is fully realised and universally adopted in research and clinics, by integrating quantitative biological knowledge from molecular to cell, tissue, organ and whole-body scales, and translating it into clinical practice. VPHi acts as a catalyst to bring together a variety of stakeholders (policy makers, science funding bodies, regulatory agencies, clinical organisations, industry) to maximise the benefit of in-silico medicine approaches for industry and public good.
VPHi will lead the development of standard operating procedures and guidelines for the in-silico testing of cardiovascular devices, in collaboration with clinical, academic and industry partners and external advisory boards, as well as strongly support dissemination activities leveraging its broad network of research centres and industries active in in-silico medicine and communication channels.