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.
Simulated onboarding workflows in hospital settings serve to pilot the point-of-care CAR-T platform, while also generating SOPs, training materials, and quality-management documents to assess personnel, infrastructure, and documentation requirements. Guided by insights from WP2 and WP3, this WP then conducts dry runs across partner sites, gathering usability feedback to iteratively refine device deployment and clinical processes while preparing for a clinical trial. Finally, interoperability tests validate data interfaces between the device, digital twin, and hospital IT systems, and a clinical study protocol is drafted alongside a comprehensive final report outlining logistics, user insights, and regulatory considerations.
Thomas is the Managing Director of PRO-LIANCE GLOBAL SOLUTIONS GmbH and brings over two decades of experience in Regulatory and Clinical Affairs for medical devices and pharmaceuticals. With a scientific background in biochemistry and molecular biology, he supports the EASYGEN Consortium by shaping regulatory strategies and contributing to the development of proposals that address current gaps inthe regulatory framework for automated point-of-care manufacturing of cellularand genetic therapies (CGTs). His consulting work focuses on clinical and biological evaluations, with a strong emphasis on aligning scientific innovation with evolving regulatory requirements.
Sabine is a medical biologist with a PhD from the University of Cologne and hands-on training in cancer research. Following her doctoral studies, she gained solid experience in the field of evaluation and development of medical devices and pharmaceuticals. In her current role as a Clinical and Regulatory Expert at PRO-LIANCE GLOBAL SOLUTIONS GmbH, she has deepened her expertise in regulatory and clinical affairs. Her work focuses on developing structured, goal-oriented solutions for clients, ensuring high-quality outcomes that align with regulatory standards—a dedication she will bring to EASYGEN consortium aiming to transform CAR-T manufacturing into a fully automated, 24-hour, point-of-care solution.
Johannes brings a diverse set of skills to support the ambitious and innovative goals ofthe EASYGEN CAR-T cell project. With a scientific background in neuroscience, immunology, and cancer research, he has demonstrated the ability to quickly grasp complex scientific concepts, as reflected in his 22 publications. His professional experience includes roles at pharmaceutical and medical device manufacturers, where he worked in clinical departments and supported products from development through to market access within large cross-functional teams. In his current role as a Regulatory & Quality Consultant, Johannes adapts swiftly to the evolving demands of various customer projects, ensuring high-quality outcomes through clear, customer-focused communication.