On the 2nd of February 2023, P4O2 has submitted a Groeifonds application to RVO (Rijksdienst voor Ondernemend Nederland). With the Groeifonds, the Dutch government aims to stimulate sustainable economic activities in the Netherlands. RVO aims to announce which projects will be granted in July 2023. For more information about the Groeifonds subsidy and projects granted in the previous rounds, please have a look at the website of RVO.
The P4O2 consortium (Predictive, Preventive, Personalized and Participatory) for more Oxygen (O2) believes the Netherlands can earn itself healthier lungs. To achieve this P4O2 is deepening and leveraging an existing collaboration. The focus of this National Growthfund application is to generate substantial economic and societal benefit by removing the current barriers that are stifling innovation for prevention of respiratory disease. Simply put P4O2 will realise a novel business model for disease prevention which represents both a substantial economic opportunity and a societal need for the Netherlands. This is of utmost importance as the Netherlands is increasingly struggling to cope with the cumulative burden of chronic respiratory disease. The annual health care costs sum up to a total amount of € 2,6 billion, and € 1 billion in lost labour productivity.
Barriers – P4O2 identifies two main barriers to innovation:
Firstly, the current structure of the Dutch HealthTech innovation ecosystem deprioritises investment into products for prevention. This is the result of a few interacting elements; 1. Market access requirements for prevention are unclear resulting in lengthy and costly R&D with high risk of poor product-market fit. 2. Reimbursement of prevention is disincentivised by the current costing structure in the Netherlands that is focused on production. Taken together this means developing and launching products for prevention are a poor and risky investment.
Secondly, effective prevention products are personalised to someone’s biology and personal circumstances. There is a lack of knowledge pertaining to the earliest stages of disease development which inhibit translation of successful personalised medicine approach from more advanced disease stages to prevention.
Consequently, there is a lack of investment in prevention and products on the market. This is contrasted by the rapidly growing wearables market indicating a consumer interest in understanding and preserving health. Combined with the knowledge that prevention has the largest ROI of any healthcare intervention this calls for immediate action. P4O2 responds to that call.
Activities and results
P4O2 aims to realize an innovative business model enabling product development for prevention of respiratory disease. It achieves this by addressing the barriers described above through a process innovation creating the required infrastructure to perform effective product development:
Workstream 1: Process Innovation
This workstream firstly focuses on creating Target Product Profiles (TPP) capturing product requirements for preventative innovations for asthma, COPD, and pulmonary fibrosis. This is done within a multi-stakeholder ecosystem including market access and reimbursement stakeholders. By obtaining pro-forma market access absolute clarity is obtained with respect to product requirements. To reduce R&D costs an innovation platform is created that bundles all required tools, knowledge and cohorts required by innovators to develop preventative products.
Workstream 2: Product development & valorisation
By building on the foundations of workstream 1 leads are progressed through a stage gate model to develop products that align with the specified TPPs. Firstly, this is done pre-competitively by individual innovators. Once passing a stage gate, those innovations that align with a TPP will be bundled into a singular study. As identical product requirements need to be proven multiple innovations and their combinations can simultaneously be evaluated within one study, resulting in significant cost and time savings.
Workstream 3: Project Management
In this program line, the required project organization is built and managed to realise P4O2 deliverables.
The impact of this approach is that it creates up front clarity for market entry and reimbursement requirements that innovators must abide to. It furthermore reduces the cost, timelines and risk associated with product development. Taken together this drastically changes the ROI equation unlocking substantial investment into preventative products for respiratory disease. P4O2 will reinvest the resulting gains to create an evergreen model of innovation and valorisation for prevention of disease. The resulting products will realise substantial societal gains.
The P4O2 partnership
P4O2 brings together 29 partners: 10 (academic) medical centres and research institutions, 16 companies and a venture capitalist to realise its ambitions by developing preventative products for COPD, asthma, and pulmonary fibrosis. The P4O2 partnership exists today and leverages historic investment of 14,5Million euros by Health-Holland. The proposed deepening and broadening of the consortium brings together the following expertise:
- Target Product Profiles (TPPs) and Market Access expertise: Key partner ACT-IVD has pioneered the concept of TPPs for medical product development and regularly advise the WHO, FDA, EU and NICE (UK) on market-access of medical innovations.
- R&D infrastructure expertise: P4O2 combines world class academic institutions experienced in respiratory research to jointly provide the basis for the innovation platform by making their laboratories, equipment, cohorts, and expertise available.
- Commercialization expertise: P4O2 includes a wide variety of innovators who have potential products for prevention of lung disease. Several partners have successfully built and/or scaled organisations in HealthTech.
- Ecosystem expertise: The P4O2 program has a proven track record in setting up effective collaborative consortia such as P4O2.
- Fundraising and start-up expertise: Within the P4O2 steering group, there is extensive experience in fundraising (>120M USD) and building start-ups, which is necessary for this market that is still developing and maturing.
P4O2 is a partnership that is open to new partners who can contribute to the P4O2 mission. Where relevant, parties can become part of the innovation platform or be developed as leads within the programme. A number of international parties are currently active within the consortium as they provide essential knowledge or skills to solve use cases that is currently not available in the Netherlands. If parties commercialise products independently of P4O2, they have guaranteed the Netherlands is a key-target market and that part of the foreground IP will end up with the Dutch researchers who contributed to the development of the product. In this way, revenue from these investments will also return to the Netherlands. More importantly, an international focus will help assure broad suitability of the developed products for the international market which represents a substantial growth opportunity for Dutch innovative products.