Exemplary Project. COILED THE NETHERLANDS April 2018

Transcription

1 Exemplary Project COILED THE NETHERLANDS April 2018

2 This document was prepared as part of the EU-funded project: ESIF Support in the area of health: building knowledge and capacities for monitoring and implementation, supporting innovation and effectiveness. Study Contract No Author: Milieu Ltd This document was produced under the EU s third Health Programme ( ) in the framework of a service contract with the Consumers, Agriculture, Health and Food Executive Agency (Chafea) acting under the mandate from the European Commission. The content of this document represents the views of the contractor and is its sole responsibly; it can in no way be taken to reflect the views of the European Commission and/or Chafea or any other body of the European Union. The European Commission and/or Chafea do not guarantee the accuracy of the data included in this report, nor do they accept responsibility for any use made by third parties thereof.

3 The Netherlands - COILED (Center of Open Innovation for Lead Discovery) General information OP information Timeline Budget Beneficiary/ies Category of intervention: Contact details Project website Thematic block covered N/A Title OP: Priority axis: Investment priority: Specific objective: Start date: End date: Total budget: Co-financing rate: EU Fund: Main beneficiary: Other organisations: Name: Organisation: Role in project: address: Name: Organisation: Role in project: address: OP East Netherlands ERDF Innovation 1B Promoting business investment in R&I, developing links and synergies between enterprises, research and development centres and higher education ( ). 1B-A Increasing the percentage of companies that cooperate with clusters and networks. 01/07/ /06/ N/A ERDF Radboud University Nijmegen Pivot Park Screening Centre, Inntrest Consultancy, BioAxis Research, Pansynt, Radboudumc Dr. Jac Wijkmans INNTREST Consultancy BV Project Leader jac.wijkmans@inntrest.com Dr. Thea van Kemenade Radboud University Business Development thea.vankemenade@ru.nl Thematic block 4: Research and Innovation in health and life sciences 1

4 Project summary COILED, which stands for Centre of Open Innovation for Lead Discovery, is a collaborative drug discovery initiative that aims to amalgamate leading academic biomedical research with industry-standard drug discovery to accelerate and valorise innovation. The initiative is building a unique drug discovery programme to deliver next generation of immunemodulatory drugs to combat disease with an unmet medical need. It was initiated to bring specialist drug discovery and medicinal chemistry skills, tools and know-how to the avail of the academic researcher, and to enable efficient and timely translation of basic scientific discoveries into innovative drug candidates. COILED aims to generate a long term sustainable Lead and Drug Development Centre in a public private setting, for value creation and value capturing, which will enable a continuous pipeline for discovery, development and transfer of new drug candidates. With the pharmaceutical industry retracting from the early stages of the drug discovery chain, there is a great need for new organisational models to address this gap. Academic medical institutions and universities are well-suited to play a strategic role in providing the required innovative biomedical concepts and hence identify new drug targets. However, with each new target, similar challenges are being faced in the process of translating scientific knowledge and modulation of biological function into suitable drug candidates. In this process, dedicated medicinal chemistry knowledge and expertise plays a pivotal role to successfully drive projects from early conception through to selection of drug candidates ready for testing in humans. By setting up strong public-private partnerships between academic biomedical researchers, industry-based medicinal chemists and R&D project managers, these stakeholders can, together, cover all stages of early target discovery, hit-to-lead optimisation and medicinal chemistry. COILED s R&D focuses on Trained Immunity, a phenomenon based on the ground-breaking research by Prof Mihai Netea, Experimental Internal Medicine at Radboud UMC (Nijmegen, NL), who showed that the innate immune system has a memory. Trained immunity is the result of the DNA of the immune cells remaining in a state of high alert for several months following an infection or other immunological insult. Epigenetic reprogramming presents the molecular basis for this process. Specific un(der)-explored epigenetic enzymes are targeted with small molecule inhibitors and activators to modulate innate immune memory in disease. Therapeutic focus areas include hyper-inflammation and/or immune deficiency-driven diseases like rheumatoid arthritis, neurodegenerative disorders, atherosclerosis, sepsis and cancer. Enzymes include distinct histone methylases and acetylases ( writers ) as well as histone demethylases and deacetylases ( erasers ). Development and Implementation Initiator/trigger There is a great need for new organizational models and innovative approaches in the early stages of drug discovery. In particular, for the identification of lead compounds, ensuing optimisation and selection of drug candidates, which form the basis for new innovative therapies. The reason for this is that, worldwide, the pharmaceutical industry has been retracting from this part of the value chain over the past decade and is instead focusing on the later stages where drug candidates have entered the phases of human clinical trials. Therefore, there is a gap to be filled between research groups and pharmaceutical companies. New business and knowledge centres, like academic drug discovery centres, are becoming key players early on in the drug discovery innovation funnel and thereby spread and reduce exploratory risks in this process. There were various reasons why the consortium decided to focus on trained immunity. Firstly, at the time when the 2

5 partners started discussing the project concept, Prof Mihai Netea was awarded the prestigious Spinoza price 2016 for his work in the area, and the topic was thus high on the agenda of Radboud UMC. Moreover, research on trained immunity is quickly developing and offers an interesting playing field for the implementation of the COILED approach as it is likely to speed up drug discovery and development processes for related diseases. Project objective Target group(s) Project health-related indicators COILED s mission is to provide a de-risked open innovation drug discovery platform/infrastructure to translate breakthrough research into drug candidates suited for clinical studies in a timely manner. More specifically, it brings together biomedical research with industry-standard medicinal chemistry during the early stages of drug discovery for the identification of lead compounds, subsequent optimisation and selection of drug candidates, which form the basis for new innovative therapies. The project focuses in particular on the phenomenon of Trained Immunity (the memory of the innate immune system), which plays a role in hyper-inflammation and/or immune deficiency-driven diseases like sepsis and cancer, as well as atherosclerosis, Parkinson s disease, and rheumatism. The project is targeting different groups: (1) academic biomedical researchers, translational medicinal chemists and screening and assay developers who are interested in working together in the context of drug discovery centres to bring early stage research to drug development; (2) patient organisations, who will benefit from the outcomes as it may result in drug development (in a timelier manner); and (3) launching customers in the field of the focussed therapeutic areas, that are open to step in and partner with COILED to address the later stages of drug development towards effective availability of new drugs. The success of the project can be defined by various measures. Firstly, by the (number of) drug candidates suited for clinical studies linked to trained immunity that will be identified through this new infrastructure for translational medicine. Secondly, by the take up by others in the Netherlands and abroad of the overall approach, and the ability to further expand into new regions or new therapeutic areas. Results Expected/attained results, outcomes and potential impacts The project has made a kick-start and has already booked various results within a relatively short timeline. So far, five biological targets have been validated of which one has been selected for screening by the end of Two more screens will be conducted in In the longer term, the approach can offer high academic, commercial and patient benefits, such as increased collaborations between stakeholders, increased number of patents and drug candidates, as well as the development of new services and 3

6 spin-offs. Success factors & Challenges Potential for replication The region where Radboud University Nijmegen is based has a strong track record in investing in research and innovation and actively supporting the creation of spin-off companies. Particularly in the areas of life sciences and health as well as chemistry. Additionally, a number of larger pharmaceutical companies used to be based in the region for several decades, the region holds an long term track record in the field of drug discovery and development, which means that a lot of knowledge and expertise as well as human resources is still present in the area. Having a project champion on board, with a track record in both the drug development process components as well as the commercial valorisation, who drives the initiative and is able to keep people engaged and motivated is a strong success factor too. Challenges encountered during the development of the project included the selection of partners. While a variety of SMEs were initially approached to assess their interest in cooperation and joining the initiative, a number of them turned down the opportunity as they did not see the immediate benefit for them to invest in it. The current consortium now realises that all of the SMEs approached did not necessarily bring in critical knowledge and expertise, and that the process of partner selection could have been shortened and simplified by only addressing the critical key expertise partners. Another challenge that the consortium currently faces is ensuring that the work stays focused and does not expand too widely and too quickly in the setting of quickly enlarging opportunities. Promising results have been achieved so far, and it is now important to further progress this success by focusing on key aspects rather than trying to quickly expand into other areas. More specifically, the therapeutic focus areas are now atherosclerosis and sepsis, while immune-oncology will be addressed at a later stage. By connecting academic biomedical research with industry-based medicinal chemistry and R&D project management, the project is establishing a powerful integrated and sustainable drug discovery centre, which, at the moment, focuses on trained immunity but has, in fact, a much wider reach. Once the blueprint for this new collaborative model has been generated to facilitate processes early on in the drug discovery innovation funnel, it could be applied to other R&D areas and implemented by academia and companies across the globe. The project thus has a very high potential for replication and for generating a number of sustainable Innovation Centres in the field of early drug discovery and development. Wider context Relevance of the project to the objective of the relevant thematic block The project is a great example of how the ESI Funds can be used to invest in the generation of new organizational models and innovative approaches that facilitate drug discovery processes and the development of new innovative therapies, as 4

7 well as creating a number of European centers with their own specific therapeutic focus. The COILED project may contribute in realizing a strong and dynamic public private European proposition in a largely expanding global market for early drug discovery. Relevance of the project objective to the specific objective of the OP Relevance of the project towards reducing health inequalities Relevance of the project towards the reform of health systems Relevance of the project objective to the national context and policy goals Relevance of the project objective to health policy goals at EU level The project strongly contributes to the specific objective of the OP as it offers a unique and innovative model that brings together academic biomedical research with industry-based medicinal chemistry and R&D project management, and therefore will eventually increase the percentage of companies that cooperate with clusters and networks. It furthermore creates a role model for public private cooperation in a long term sustainable expertise center that will drive the vitality and dynamics of a new European proposition in a global market, increasing the economic vitality of drug development companies or related market segments. With generating a new role and business model, this will drive and help the research & development of SME s in the field toward new economic perspectives. The project does not have a specific objective that contributes to reducing health inequalities. In general, COILED aims to reduce societal costs of drug development and contributes with their activities towards the broad availability of drugs in the area of trained immunity for all regions worldwide (rich and poor). In this sense, by filling in the hole of early drug development by a public private undertaking, it provides means for a fairer distribution of drugs and help to reduce current inequalities in public and/or private health care. The project has an impact on the execution and management of the early phases of drug discovery processes but does not necessarily contribute to the reform of the Dutch healthcare system directly. However, by reducing costs in the early drug development stages in an open public-private innovation setting, it may have a contribution in the reduction of costs and broad availability and distribution of drugs in the field of trained immunity and related therapeutic areas. According to the CSR of 2017 for the Netherlands, public and private R&D spending are relatively low, which limits the growth and potential of the economy. This project addresses this gap. The project promotes research and innovation, which is one of the fundamental objectives of the Europe 2020 strategy. An initiative Innovation Union aims to focus R&D and innovation policy on the challenges facing our society, including health and demographic change. 5