Multiple sclerosis (MS) is an inflammatory neurodegenerative disease of the central nervous system for which no cure is currently available. It is the leading cause of non-traumatic disabling neurological disease in young adults with more than 500,000 people affected in Europe. As chronic inflammatory processes drive the neurodegeneration, we hypothesize that improved clinical outcome can be achieved by restoring the balance between inflammation and the remaining capacity of neuronal self-renewal. In this context, cell therapy that specifically targets the damaging immune reactions that cause MS, thereby reducing the autoreactive, inflammatory assaults in MS without affecting protective immunity against pathogens and cancer, can be a promising approach to allow for more repair. Recently, we set-up a collaborative network of European centers working in cell therapy (COST Action BM1305). From this, a multidisciplinary team from four different EU countries (B, ES, NL and GER) with two additional partners now aims to safely reach the next level of testing and joins efforts to bring antigen-specific cell therapy for MS to the clinic. Our objectives are to evaluate safety, clinical practicality and demonstrate first proof-of-principle of therapeutic efficacy of antigen-specific tolerance-inducing dendritic cells (tolDC) in MS patients in two single-center clinical trials. All regulatory approvals are already in place. Coordinated patient monitoring and centralized MRI monitoring, including radiological correlates of neurodegeneration, and immunomonitoring will enable us to directly compare results between trials and enable consented biobanking, data safeguarding and accessibility to support future efforts in the field of MS therapy. ReSToRe focuses on the advancement of an innovative cell therapy approach with the potential to improve the lives of patients suffering from MS, a currently untreatable disease. This would represent a breakthrough for healthcare in MS.

Parkinson Disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease. There is an unmet clinical need to treat Parkinson disease with mild cognitive impairment (PD-MCI). There is ample evidence from epidemiological studies as well as (pre)clinical research that Nicotinic receptors are involved in PD and cognition. Recently a clinical trial suggested that selective α7 nicotinic receptor agonist improved cognition in PD patients, as a secondary outcome measure. Hence, the main goal of PD-MIND is to show the potential of the Astrazeneca nicotinic α7 agonist AZD0328 in a randomized, placebo-controlled, international multicentre, cross-over study on cognition in people diagnosed with PD-MCI. We will assess the Attention Intensity Index composite score from the CogTrackTM system as primary outcome measure and other clinical aspects (cognition, motor symptoms) as secondary outcomes. In addition, blood, CSF and imaging biomarkers will be assessed as potential predictors of response, and as marker of target involvement. Patients (Public and Patient Involvement) and other stakeholders will be engaged from the start to allow integration of end-user perspectives in the design and execution of the project. PD-MIND will put considerably effort to disseminate and exploit clinical outcome data and biomarker results, and to sustain the partnership for subsequent phase 3 clinical studies. PD-MIND consortium consist of world-leading PD-MCI experts in the area of clinical trials, clinical coordination, project management, data management and analysis, and biomarkers. As such the consortium is well positioned to execute the proposed work and complement the EFPIA members.

Oral diseases and conditions affect more than 3.5 billion people worldwide. They are the 3rd most expensive diseases to treat in the EU and disproportionally affect vulnerable groups. In deviation from the UN and WHO goal of Universal Health Coverage, many EU citizens do not have access to quality oral care without financial hardship. To this end, the DELIVER (DELiberative ImproVEment of oRal care quality) project aims to enhance the quality of oral care through deliberative dialogue and action involving citizens, patients, providers, payers and policymakers. DELIVER will create a synergistic problem-solving ecosystem to convert deliberative dialogues into meaningful improvement of oral care quality. DELIVER brings together top investigators from prestigious universities, civil society and patient organizations, health professionals, policymakers, and SME/industry to achieve a step change in collective problem solving. Given the comprehensiveness of the topic, DELIVER uses a targeted approach that is entirely focused on five major root-causes underlying the current limitations of oral care systems. Using a mixed-methods research approach, DELIVER will co-develop and co-produce new quality improvement approaches in three phases. The 1st phase involves situational analysis, consenting of core quality indicators, and development of a EU-wide monitoring framework. The 2nd phase involves in-depth analysis of select quality improvement approaches: (i) PROMs/PREMs-based quality improvement in dental practices; (ii) community-based quality improvement for vulnerable groups; (iii) quality-oriented commissioning of oral health services. The regulatory determinants of oral care quality improvement will be scrutinized. In the 3rd and final phase, the knowledge gained in the 1st and 2nd phases will be merged into the DELIVER Quality Toolkit with manuals and digital tools for concretely actionable and context-adaptive approaches for oral care quality improvement.

Oral diseases and conditions are the 3rd most expensive diseases to treat in the EU. They affect about half of the EU population. As highlighted in the 2021 WHO Oral Health Resolution, there are major challenges in the financing of oral health care: in deviation from the UN and WHO goal of Universal Health Coverage, many EU citizens do not have access to essential oral health care without financial hardship. This causes detrimental impacts for the individual citizen, while increasing costs and wasting resources on the macro level. Research-policy gaps and research-practice gaps keep triggering inertia and inaction instead of addressing the persistent, albeit largely preventable, burden of oral diseases. To this end, the PRUDENT (Prioritization, incentives and Resource use for sUstainable DENTistry) project aims to develop and implement an innovative and context-adaptive framework for optimized financing of oral care. PRUDENT brings together top investigators from prestigious universities, public authorities and policymakers, civil society and patient organizations, health insurers, and health professionals, to achieve a step change in collective problem solving. Given the comprehensiveness of the topic, PRUDENT uses a targeted approach that is entirely focused on four major root-causes underlying the current limitations of oral care financing. Using a mixed-methods research approach, PRUDENT will: (i) co-develop oral health system performance indicators and implement them in EU-wide monitoring framework; (ii) conduct real-world and lab experiments to identify improved oral care financing mechanisms; (iii) leverage regulatory learning, needs-adaptive resource planning and deliberative priority setting to enhance the improvement of oral care financing. The knowledge gained will be merged into the PRUDENT Financing Companion with policy briefs and decision aid tools for concretely actionable and context-adaptive improvement of oral care financing.