RegMed XB not only drives research that is a step towards realizing one or more Moonshots, it pro-actively seeks to turn platform or enabling technologies and novel therapies into viable businesses by licensing to and collaborating with existing companies or start-ups. The Dutch Ministries of Economic Affairs and Climate (EZK) and Health, Wellbeing and Sport (VWS) support this by setting up a Public-Private Entrepreneurship Fund to provide project finance loans to such collaborations. In addition, the participating regions (Brabant, Utrecht, South-Holland, and Limburg) are investing heavily in (seed) capital and infrastructure to support (start-up) companies and (production) development. All this work is aimed at creating a world-leading RM ecosystem to advance the Moonshots and realize impact for Dutch society and regional economies.
For regenerative medicine, this is an even greater challenge. It is an emerging industry for which novel manufacturing strategies, business models, and a regulatory framework must be developed in parallel to the RM technologies and therapies themselves. There are many advances to be made in engineering and manufacturing technology (e.g. local processing close to the patient for therapies using his/her own cells or scaling harvesting, processing, and formulation technologies for donor cells). Many regenerative therapies will require novel business models, such as licensing treatment protocols or providing materials and training rather than medicinal products or devices. It is also still unclear how clinical safety and efficacy should be established.
The traditional approach, as in the pharmaceutical industry, of passing a product concept to another team or company to develop scalable production, perform large scale clinical trials and set up global distribution, will not work – especially as there are few or no such companies. It needs experienced entrepreneurs who know how to address manufacturing, commercial and regulatory challenges from the start.