One of the pillars of the RegMed XB ecosystem initiative is the development of a manufacturing infrastructure. This responds to major challenges in making RM therapies available and affordable to patients, namely the development and industrialization of manufacturing. This is complex (working with living material), must meet high standards (Good Manufacturing Practice) and is currently still labor intensive and not automated. RegMed XB (and its partners) will use Growth Fund resources to realize a national RM infrastructure in the Netherlands, consisting of an ecosystem of pilot lines that support companies and research institutions in developing and valorizing new RM therapies, production technology and production services. Together they cover the entire chain from biomaterials to cells, micro tissues and whole organs, and every possible scale from personalized applications to the development of industrial production. Each link provides both products and services that are directly applicable in (RM) therapies and intermediate or auxiliary products for other steps in the chain.
Around each pilot line, companies and knowledge institutions work together on further development of (clinical) applications and increasingly better, cheaper, scalable and exportable production equipment and services. With a start in 2021, most of the physical infrastructure will be realized between 2022 and 2024 (in parallel with the required technology platforms). Starting in 2023, the integrated pilot proposition will be open for business as part of the larger ecosystem proposition of RegMed XB. The use of the pilot lines is scaled up between 2025 and 2028 and they generate sufficient revenue after 2028 to cover the costs of operations, maintenance and equipment replacement. Revenue consists of capacity rental, provision of services (expertise, support), provision of education and training, commissioned production, development of production platforms and revenue from spinouts in production equipment and licensing.
Customers/users of the RM infrastructure can make use of all facilities and expertise in the strong ecosystems around each pilot line – around TU/e (SBMC), Leiden Bio Science Park (NecstGen and LUMC), Utrecht Science Park (UMC Utrecht) and Maastricht Health or the Chemelot Campus (ReGEN Biomedical) – and in the broader ecosystem of RegMed XB. In and around the RM infrastructure, a wide range of facilities but also of knowledge / skills will be available: (clinical) validation and valorization, from patent to patient, including hands-on support and funding for startups, assistance in complying with and helping to shape regulations and active involvement of health funds, patient (associations) and insurers. This makes it attractive for new and existing companies from home and abroad to establish themselves at one of the science parks where parts of the RG infrastructure are located and then become/ are part of the RM ecosystem in the Netherlands.
The world faces major challenges in health and healthcare. Aging and changing lifestyles are leading to a rapid increase in the number of chronically ill people and those in need of care everywhere. Meanwhile, technological innovation is saving lives, but the downside is that (even) more people are living longer with chronic illness. Our current healthcare system is entirely geared to care for the chronically sick: relieving symptoms and slowing down disease progression. This is expensive and labor-intensive; it is not sustainable in the long term. Capacity shortages are already emerging. The COVID-19 pandemic underscores the scale and urgency of challenges surrounding the overload of our healthcare system.
Regenerative Medicine (RM) focuses on repairing damage to cells, tissues and organs that can prevent or cure chronic diseases. Cells, tissues and (mini-)organs grown outside the body can also be used to diagnose and treat diseases more accurately and more patient-specifically (personalized medicine). Regenerative medicine is the driving force behind the transitions needed to keep our population healthy and our healthcare affordable: from care to cure, from one-size-fits-all to personalization and precision and from reactive to proactive and preventive. The international market potential for regenerative medicine is large and rapidly growing, and the Netherlands has an excellent starting position with an internationally leading knowledge base and an emerging business community in this new sector. A huge opportunity for RM to contribute to the future earning power and health of the Netherlands.