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 or start-up companies.
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.
The challenge: entrepreneurship, expertise, initial funding, and longer incubation
There is a well-known gap between publicly funded inventions and private investments in clinical and commercial development (see figure). Called the “valley of death”, it is generally attributed to the insufficiency of public resources to develop promising concepts to sufficient maturity for commercial investment. But this lack of funding is more a symptom than a root cause. There is no shortage of money for a good idea, but too few good ideas are sufficiently de-risked to be investable – i.e. have a credible team, technical dossier, and business plan to develop and validate a product that is clinically effective, compliant with regulations and commercially viable. Most researchers and spin-outs from universities have scientific knowledge but lack product development and regulatory expertise, and the experience of building a (biomedical) business. As a result, inexperienced teams struggle to advance promising concepts and other concepts stall or fail for lack of a good entrepreneur – and a lot of time and money is wasted reinventing the wheel.
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.