RegMed XB Participants Portal
This portal and all of its information and documents are confidential and/or proprietary information and is intended for RegMed XB consortium partners only.
The structure of RegMed XB is based on 5 Pillars (Fig.1). Overarching over the 5 pillars there is attention for ‘Ecosystem development’. The ‘Ecosystem’ is the network of researchers, patients, institutes, companies, health foundations, regulatory bodies, governments, healthcare insurers, investors, etc., that interactively contribute to the development of the moonshots. RegMed XB will not only accelerate solutions on an incidental basis but will also accelerate them structurally towards patients and markets. These structural solutions require sustainable reinforcement of the ecosystem and culture. Therefore, the goal of the educational plan is to develop research and development skills and entrepreneurial skills for any researcher taking part in RegMed XB and make them more aware of the societal impact of their work.
Figure 1 The 5 pillars of RegMed XB
The educational plan targets three important areas: research excellence, society and entrepreneurship (Fig.2). The plan consists of a list of courses, seminars and workshops, which increases the understanding between these areas. The courses are open for every person within RegMedXB and the goals differ per pillar. For example, a researcher can choose a research specific course, which will help with their work in the Moonshot and further their scientific abilities/career. But he or she may also wants to participate in a course on Intellectual Property (IP & valorization) or attend a workshop on how to involve expert patients or interact with the public. Our ambition is to foster interaction between all three areas. Patients and the public are invited to discover more about RegMed XB and have discussions with researchers about the societal impact on an annual basis.
RegMed XB encourages academics, patients and entrepreneurs to broaden their knowledge by engaging them in the RegMed XB society and expose them to all possibilities the RegMed XB ecosystem holds. The goal is to prepare the talents of today to become the leaders of tomorrow to successfully impact patients’ lives and society.
Figure 2 Triangle of the target areas of the educational plan
Regenerative Medicine Crossing Borders
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.