There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these has been assessed. This calls for pragmatic science-based approaches for prioritising existing APIs in terms of their environmental risk. Such approaches could also be used pro-actively, i.e. to identify environmental concerns earlier in the drug development process, thereby contributing to a more sustainable future. The overall aim of PREMIER is to deliver an API information and assessment system for characterising the potential environmental risks of APIs, including relevant human metabolites and environmental transformation products, based on minimal testing. This system will be designed to screen and prioritise legacy APIs for tailored environmental assessment; identify potential environmental hazards associated with APIs in development; and to make the available environmental data more accessible for all stakeholders. The system will be optimized and validated using case studies on approximately 25 APIs. PREMIER will realize its aim by combining world-leading research on the environmental risks of APIs with the principles of co-design and smart knowledge-based IT. Through this combination, we want to be more than a conventional research project. We want to ensure that the results of our ground-breaking research “work” address all the societal concerns about the potential risks posed by the presence of pharmaceuticals in the environment.

RSV causes severe disease in the very young and elderly and results in substantial healthcare costs. In the last 4 years, substantial progress has been made in development of products for active and passive immunization against RSV, with 19 products currently in clinical development. In 2017, we were funded by IMI to set up RESCEU project (Grant Agreement number 116019), which is the single largest consortium currently working on RSV and has addressed several of the key evidence gaps to inform the introduction of an RSV vaccine. However, new gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes (not addressed within RESCEU) remain unmet. PROMISE’s vision is to seamlessly build on, exploit, and add value to the significant achievements of RESCEU to prepare for the imminent introduction of an RSV vaccine. Expanding the existing RESCEU network to include 5 new partners, PROMISE comprises of 5 distinct but inter-connected work packages (WPs). WP 1 will conduct epidemiological and cost-effectiveness analyses marshalling data from systematic reviews; national and regional disease registries; surveillance programmes and linked routine healthcare datasets. WP2 will foster a consensus and develop an operational plan for expanded coordinated RSV surveillance and reporting activities; post-licensure monitoring and evaluation of products for RSV immunization across Europe. WP3 will initiate new prospective studies to address key gaps in existing knowledge (RSV disease severity scores, asthma in school age children) and assemble biobanks for biomarker validation. WP4 will validate temporally and at mucosal level biomarkers that were identified in RESCEU adopting state of the art technologies. WPs 1-4 will develop high-quality, sustainable, robust data collection systems that link closely with public health/regulatory bodies/health care providers for informing policy and regulatory processes.

The European Rare Diseases Research Alliance (ERDERA) aims to improve the health and well-being of the 30 million people living with a rare disease in Europe, by making Europe a world leader in Rare Disease (RD) research and innovation, to support concrete health benefits to rare disease patients, through better prevention, diagnosis and treatment. This Partnership will deliver a RD ecosystem that builds on the successes of previous programmes by supporting robust patient need-led research, developing new diagnostic methods and pathways, spearheading the digital transformational change connecting the dots between care, patient data and research, while ensuring strong alignment of strategies in RD research across countries and regions. Structuring goal-oriented public-private collaborations targeted at interventions all along the R&D value chain will ensure that the journey from knowledge to patient impact is expedited, thereby optimising EU innovation potential in RD. To support its ambition and missions ERDERA has been designed as a comprehensive and integrated ecosystem of which structure can be compared to an institute encompassing three main parts: (i) funding, (ii) internal (in house) Clinical Research Network that implements research activities targeting clinical trial readiness of RDs and accelerating diagnosis and translation of research discovery into improved patient care, and (iii) related supporting services (Data, Expertise, Education and Training) as well as an acceleration hub that serve external and internal RD community, all supported by all-embracing coordination and strategy and foundational (inter)national alignment.

EU-PEARL has the ambition of transforming the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients’ interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing have the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL will improve clinical effectiveness, patients’ satisfaction and societal access to timely and affordable medicines and it will shape the clinical trials of the future. This will change the industry paradigm from competition to cooperation in four disease areas and provide the framework for designing IRPs in other disease areas. The main objectives of EU-PEARL are: (1) To create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross- company IRP in any disease area with unmet needs; (2) To set up the open, dynamic, patient inclusive IRP governance structure that will manage the appropriate regulatory, ethical, legal, statistical and data utilisation requirements of the IRP; (3) To disseminate and exploit the EU-PEARL paradigm through the provision of the necessary common tools, procedures, expertise and operational skills working to the highest scientific, regulatory and ethical standards and best practices, developed jointly by public and industry partners in a consensus-based approach; and (4) To create trial-ready IRP networks in the four disease areas of Major Depressive Disorder (MDD), Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis (NF).

The "Widening Synergies for Novel Enzymes Development" (WIDEnzymes) project aims to foster the creation of a unique cross-border collaborative ecosystem devoted to advancing enzyme technology in the EU. This endeavor follows the well-established Profiling Regional Innovation Ecosystems methodology and centers its efforts on two key domains: joint internationalization and inclusive talent development. Through the implementation of strong synergies within the consortium, beneficiaries will be able to both enhance their potential and increase the impact of their research projects significantly. Sharing competencies and state-of-the-art equipment will allow the beneficiaries to increase their critical mass and scientific excellence, and therefore to compete in Horizon Europe calls with European countries whose R&I potential is traditionally more established. The inclusion of two non-widening partners, one academic and one SME, with strong expertise in innovations' exploitation, large public-private partnerships, and different EU funding applications is a key accelerator factor to elevate the consortium's preparedness and competitiveness. It is envisioned that the vigorous training and student exchange program implemented by WIDEnzymes will attract students and young researchers alike, thus allowing the creation of a highly educated and competitive workforce that can tackle ambitious research projects and secure funding at the European level. The WIDEnzymes project seeks to bridge borders and boundaries in the pursuit of cutting-edge enzyme technology. By fostering collaboration, leveraging funding opportunities, nurturing talent, adopting a multisector approach, and enhancing visibility, we aim to propel enzyme technology to new heights. Through these endeavors, we aspire to make a lasting impact on science, industry, and the society at large.