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© Artur - stock.adobe.com / Fraunhofer IZI

Our Consortium

CERTAINTY has been established to harness a wide range of expert knowledge with the goal of creating a lasting VT ecosystem to aid patients who qualify for CAR T cell therapy. To ensure comprehensive coverage of CERTAINTY's objectives, various esteemed European institutions, small and medium enterprises (SMEs), patient organisations, and industry players, each bringing different areas of expertise, have collaborated to form this consortium.

Abstract Background

Insights Shared by Team Members

Kristin Reiche

Dr. Kristin Reiche, FHG IZI, CERTAINTY Coordinator

“From a computer science perspective, we view the patient's unique CAR T cells as a living therapy, i.e., as a biological system. As CAR T cells interact with a living system, namely the patient, approaches to personalised medicine require rethinking and innovation. Thus, our goal is to combine the patient's unique molecular, cellular, and clinical data with the CAR T cell product's unique molecular and cellular data, paving the way for personalised therapy response and risk profiles. Given the current emerging role of CAR T cells in multiple myeloma, it serves as a crystallisation point for other malignancies with comparable treatment paradigms.”
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Fraunhofer - Project coordinator

Germany

The consortium is coordinated by Fraunhofer (FHG). Fraunhofer, based in Germany, is the world’s leading applied research organisation. Fraunhofer excels in pioneering sustainable research and merging academic insights with industrial applications. The research organisation operates 76 institutes. Three of them (Fraunhofer IZI, Fraunhofer SCAI, Fraunhofer IMW), contribute diverse expertise to the consortium.

 

FHG IZI, at the forefront, is the first in Europe to produce clinical-grade CAR T cell therapy in a GMP facility. Its ISO9001:2015 certified Biomarker Centre at Fraunhofer IZI has deep experience in developing advanced diagnostic, predictive, and prognostic methods using Next-Generation Sequencing. With strengths in computational biology, bioinformatics, machine learning, and algorithm development compliant with IEC62304, the consortium ensures the effective translation of biomarkers into diagnostics.

FHG SCAI is devoted to the development of cutting-edge algorithmic solutions and mathematical simulations. The AI & Data Science team at FHG SCAI builds on a long-lasting experience in the development and application of AI/ML models for applications in biomedicine, specifically in early drug development and precision medicine. Within CERTAINTY, they will leverage this expertise to deliver (generative) AI/ML models to support medical treatment decisions. Furthermore, SCAI's IT team will set up and maintain a federated learning platform for the entire project.

 

FHG IMW looks back on more than eighteen years of applied socio-economic research. The Digital Health team at FHG IMW builds on its expertise in the areas of market and environment analysis, as well as needs, requirements, and acceptance analysis. A decisive contribution to the project is stakeholder management, which is a core competence of the Digital Health group involved and ensures that the interests and requirements of all those involved can be incorporated into the progress of the project. The opinions of the users will continue to be incorporated as the project progresses. This will take place as part of the usability evaluation, which is also being managed by FHG IMW. 

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Leipzig University

Germany

Leipzig University possesses extensive experience in agile software development for Models of Personalised Medicine, collaborating with industry partners and clinicians across various fields. The University Hospital Leipzig (UKL) stands as the sole centre in Europe to administer all approved CAR T cell therapies. UKL boasts vast expertise in the clinical management of patients receiving CAR T cell treatments, both outside of and within Phase I-III clinical studies. Complementing the clinical efforts, a translational research programme, inclusive of longitudinal biobanking of patient-derived samples for Next-Generation Sequencing (NGS) analyses, runs concurrently.

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Singleron Biotechnologies

Germany

Singleron advances precision medicine and life science research through pioneering single cell multi-omics solutions. Its portfolio includes extensive services for research to clinical trials as well as instruments for automated single-cell processing and tissue dissociation, reagents, bioinformatics software, and a comprehensive single-cell knowledge base. As a CERTAINTY participant and task lead of WP5, Singleron produces high-quality single-cell data to complement conventional health data sets and strives to integrate a workflow for extended companion diagnostics for CAR T cell therapies. 

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Collaborate Project Management

Germany

Collaborate Project Management possesses extensive expertise in project management and administration. Within CERTAINTY, their involvement is central to WP1, which focuses on project management aspects. Additionally, they lead WP7, where they will oversee and direct efforts related to dissemination, communication, and exploitation.

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Myeloma Patients Europe

Belgium

Myeloma Patients Europe (MPE) is an umbrella organisation of myeloma and AL amyloidosis patient groups across Europe. MPE currently has 52 members based in 33 countries. The mission of the organisation is to provide education, information, and support to member groups and to advocate at European, national, and local levels for the best possible research and equal access to treatment and care. To achieve its aims, MPE works directly with members, healthcare professionals, reimbursement authorities, regulators, politicians, pharmaceutical companies, and the media to ensure all stakeholders collaborate to improve patient outcomes and reduce inequalities across Europe. In this context, MPE is dedicated to improving access to CAR T treatment and to making sure that the patient voice is represented throughout the project and that patients' needs and concerns are addressed.

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TriNetX Oncology

Germany

TriNetX is among the most recognised providers of real-world evidence for oncology and haematology in Europe. Its methodologies and data are increasingly utilised for health technology assessments in Germany and other European nations. TriNetX has crafted a sophisticated approach for the retrospective and anonymised gathering of longitudinal treatment data and individual patient information, drawing from a representative sample of institutions within each targeted country.

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Masaryk University

Czechia

Masaryk University (MUNI) through the expertise in its Central European Centre for Advanced Therapy and Immunotherapy (CREATIC), which aims to support research, development, and production of advanced therapy medicinal products (ATMPs) for patients with rare diseases in regional hospitals, contributes expertise in the socio-economic dimension of ATMPs, legal and pharmacoeconomic aspects. It is also part of the working group organising the implementation of the European Open Science Cloud (EOSC) in the Czech Republic. CREATIC Data Science Unit provides expertise in data management and analysis, across the diverse landscape of healthcare data, thus making MUNI a reliable data partner.

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EBMT

Netherlands

EBMT is a collective of healthcare professionals engaged in clinical blood and marrow transplantation and cellular therapy. The EBMT Registry, Europe's most extensive patient database, includes a cellular therapy module that has garnered a favourable qualification opinion from the EMA, endorsing the use of real-world data from the EBMT Registry in guiding regulatory decisions. 

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University Hospital Würzburg 

Germany

University Hospital Würzburg is a centre of excellence for translational and clinical research in cancer immunotherapy, specifically with chimeric antigen receptor (CAR) T cells. It boasts an outstanding track record in the immunotherapy arena, practical experience in developing and clinically deploying cellular immunotherapy, and a comprehensive network within the medical, scientific, patient, regulatory, and entrepreneurial communities.

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Information Technology for Translational Medicine

Luxembourg

ITTM, an SME with experience in diverse Data Curation and Management projects within the framework of past and current H2020 and IMI initiatives, is tasked with the integration of data into the VT in WP2. As a member of the i2b2 tranSMART Foundation, ITTM stands out as one of the initial SMEs to have undergone training and achieved certification as an EHDEN Certified SME.

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University of Namur

Belgium

The university of Namur specialises in a broad range of topics pertinent to the information society, including privacy, intellectual property, e-health, big data, cybersecurity, the Internet of Things, and algorithmic governance.

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University Medical Center Utrecht

Netherlands

University Medical Center Utrecht specialises in creating new treatments from gdTCR receptors and co-stimulation, known as costim-TEGs. They are also leading in modelling spatial immune interactions in the 3D bone marrow niche and against solid tumours using tumour-derived organoids.

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Institut Curie

France

Institut Curie specialises in developing mathematical models through various formalisms, including nonlinear ordinary differential equations and Boolean formalisms, to tackle specific biological queries pertinent to cancer, with the objective of offering personalised treatments. IC has been at the forefront of creating personalised, literature-based models utilising individual patient omics data and has collaboratively refined methods to enhance the simulations of these mathematical models. This includes the development of agent-based models with intricate intracellular details, which is a key focus of this project.

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Charité – Universitätsmedizin Berlin

Germany

The Charité Universitätsmedizin Berlin is one of the largest academic medical centres in Europe playing an important role in the rapidly expanding field of immunotherapies. Using access to a large number of clinical cases, the Charité is dedicated to elucidating the molecular mechanisms of diseases and translation into medical practice. This is ensured by a network of state of the art technology platforms, single-cell technologies, systems biology approaches, and clinically relevant experimental disease models.

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HealthTree

United States

HealthTree Foundation leads in empowering multiple myeloma patients and contributes self-reported patient data to the project. Its primary expertise lies in the validated real-world data of myeloma patients, including self-reported information from those who have received CAR T cell therapy, alongside user-interface design tailored for patients, clinicians, and researchers. HealthTree is distinguished for its exceptional ability to consolidate all of a patient's medical records in a single location, becoming the first cancer foundation to achieve this. Patients have generously donated their records to hasten the search for a cure.

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Roche - Associated Partner

Switzerland

Roche boasts an expanding portfolio of haematologic treatments and has formed a strategic global alliance with Poseida Therapeutics, focusing on allogeneic CAR T cell therapies for haematologic cancers, starting with multiple myeloma. Within the Consortium, Roche brings expertise in statistics, clinical practices, regulatory affairs, real-world data (RWD), and biomarkers. The company contributes to prognostic and predictive modelling, study design, and RWD. It plays a role in shaping the project's communication, publication, and exploitation strategies and participates in stakeholder interviews to refine software requirements. Roche also plans to share anonymised clinical data from its sponsored studies with the consortium.

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