RegMed XB “Towards industrial-scale organoid-based tissue manufacturing”
Regenerative Medicine (RG) is a new field in medicine that focuses on the repair and restoration of tissue/organ function, with the potential of full functional replacement in case of total organ failure. There is a realistic expectation based on existing scientific evidence, that the production of organoid-based functional living implants and organs becomes within reach. Proof of concept was published by several groups demonstrating the creation of functional tissue implants that mimick the body’s normal physiological processes during growth and development.
The development of industrial-scale manufacturing platforms for the cost-effective production of organoid-based tissue-engineered implants and organs is a requirement to maximize patient access while providing commercially viable products. RegMed XB aims to realize such a platform in Europe championed by the Vanguard Initiative allowing to connect the regions with expertise to contribute to fully integrated and connected production lines of living functional implants such as auxiliary kidney tissues, glucose-responsive beta-cell organoids, and living implants for orthopedic applications such as hemi-joints. RegMed XB wants to realize an RG pilot factory consisting of an ecosystem of pilot lines that support companies and research institutions in the development and valorisation of new RG therapies, production technology, and production services: from small-scale, market-oriented R&D activities and production to research and personalized treatment to equipment development for large-scale, affordable production for market applications.
Since its start, the youngest pilot of VI has been receiving massive interest from regions and the number of new projects and demo case ideas pitched is constantly growing. With a view to maintain a reasonable and manageable number of demo cases within the Pilot and to ensure the viability and sustainability of these demo cases, a new process has been developed at the Pilot level to select new project and demo case ideas and make sure they are fully in line with the Pilot’s scope and framework of activities.
Hence, a specific template was designed covering 10 categories including, but not limited to, the link to the smart health pilot’s pillars and topics, the interregional dimension, the financing plan, the contribution to the industry value chain, the TRL level, wider expected impacts, etc. New demo case ideas brought to the pilot will be asked to self-assess their project and demo case ideas against these 10 categories. This self-assessment will then be subject to a review with the pilot steering committee who will validate and accept or not the new project and demo case idea in the pilot.
Other VI Pilots and in particular the 3DP Pilot has also developed a similar template and assessment process. As such, the Smart Health and 3DP pilots are currently discussing a joint initiative to develop one single harmonised and streamlined process that could be implemented at all pilot levels. This could include the creation of dedicated calls for new project and demo case ideas across all VI pilots during the year with predefined deadlines.