Current and future CAR-T care processes are mapped, analyzed and enhanced under real-world constraints. Through expert interviews, and KPI definition, partners will build detailed process diagrams and quantitative baselines to inform discrete-event simulation models. These models will be calibrated, used for “what-if” analyses to develop resource concepts (layout, staffing, logistics) and contribute to the performance evaluation in WP3. In parallel, qualitative co-creation workshops with clinicians ensure that user insights drive the design of optimized workflows, SOPs, and training materials.
A PESTEL analysis and expert interviews map out all external influences and key actors to pinpoint the political, economic, social and regulatory factors that will shape technology adoption. It then translates stakeholder insights into prioritized technical and usability requirements via targeted questionnaires, ensuring the device meets real-world needs. Building on this, acceptance studies systematically gather and analyze stakeholders feedback to establish clear criteria for end-user buy-in, and a comprehensive cost-effectiveness model compares point-of-care versus conventional CAR-T therapies (including QALYs, long-term follow-ups, Monte Carlo sensitivity analysis, and workflow-driven cost inputs) to guide strategic decision-making.
WP4 defines and validates patient eligibility criteria to identify new cohorts who stand to benefit from the modular CAR-T device, leveraging clinical expertise and data analytics to model anticipated outcomes. A comprehensive market and competitor analysis maps current trends, barriers to entry, and growth projections, informing optimal positioning within healthcare systems. Finally, insights from WP2 are used for exploitation and sustainability strategies that outline clear commercialization pathways, partner engagement, and scalable roll-out plans to ensure long-term integration and impact of the innovation.
A robust regulatory roadmap is crafted for both the CGT proof-of-concept platform and the modular CAR-T procedure. Early engagement with Notified Bodies and competent authorities ensures that device classification, pre-clinical testing, and evolving regulations are addressed in real time. A detailed European regulatory landscape analysis across EU countries (starting with Germany, Spain) informs consultation with TÜV, PEI, EMA, and other agencies, while comprehensive GMP documentation - including validation plans, risk assessments, and supplier qualification - lays the groundwork for compliant manufacturing in WP6.
Same-day CAR-T production is established and refined through the comparison of novel vector and gene-editing strategies with classical methods. Both processes are then standardized to ensure consistent, clinical-scale use. It develops cutting-edge analytical assays - leveraging CRISPR off-target profiling, 3D ex vivo efficacy screens, and cytokine-release monitoring - to qualify edited cells for safety and potency. Finally, it conducts paired comparisons of the new rapid workflow versus traditional ex vivo culture to demonstrate equivalence or superiority in product quality.
To share EASYGEN’s findings with scientific, clinical, and public audiences the team develops a dynamic dissemination and communication strategy – featuring a unified brand identity, website, social media presence and toolkit for presentations and press releases. It conducts a literature review on CAR-T patient quality of life (QoL), including a patient questionnaire to assess patient-reported burden to access CAR-T cell therapy, to inform targeted messaging and convenes roundtable workshops with patient advocacy groups to co-create educational resources and a white paper on lived-experience insights. Ongoing stakeholder networking ensures that healthcare providers and patients are actively engaged throughout the project’s lifespan.
Julia is a Research Director and Therapeutic Area Lead for Oncology at Charles River Laboratories in Freiburg, Germany. She earned her DVM from Freie Universität Berlin and Tierspital Zürich, followed by a PhD and postdoctoral work at the Max Planck Institute focused on immunobiology. Since Charles River’s acquisition of Oncotest in 2015, she has overseen PDX-based oncology drug testing platforms, integrating 3D tumor models, in vivo assays, imaging, omics, and translational biomarker development.
Kanstantin is heading in vitro assay development in Freiburg and comes from a pharmacy/chemistry background. He mainly focuses on methodology, including Design of Experiments (DoE) and data handling, as well as everything related to plate-based cellular assays—such as live-cell imaging in 2D and 3D models, reporter gene systems, biomarkers, different detection technologies, and others.
Ina is a Scientist in Assay Development at Charles River Laboratories, based in Freiburg im Breisgau. She earned her degree from Hochschule Albstadt‑Sigmaringen and has built strong expertise in designing and optimizing cellular and biochemical assays. Ina collaborates across interdisciplinary teams to support bioanalytical project objectives, ensuring precise, reproducible testing protocols. With a solution-focused approach and solid technical acumen, she consistently contributes to advancing preclinical research in drug development.
