The European Regimen Accelerator for Tuberculosis (ERA4TB) has the explicit goal of developing a new combination therapy to treat all forms of TB starting from ~20 leads and drug candidates provided by EFPIA. Since details of these are as yet unavailable, we will implement an agile drug development algorithm that entails profiling and portfolio construction. Profiling involves characterisation and ranking molecules in preclinical studies comprising in vitro drug combination assays, hollow fiber and single cell analysis, innovative murine and non-human primate models, PK/PD studies, combined with biomarker discovery and non-invasive NIR or PET/CT imaging to monitor disease progression and response to treatment. Modelling, simulation and artificial intelligence tools will help progress compounds from early preclinical to clinical development and to predict drug exposure, human doses and the best combinations. After extensive preclinical profiling, selected compounds will enter portfolio development for first time in human tests and phase I clinical trials in order to ensure that they are safe, well-tolerated and bioavailable with negligible drug-drug interactions. If needed, formulation studies will be conducted to improve pharmacological properties. ERA4TB has assembled the best expertise and resources available in Europe, to build a highly effective and sustainable drug development consortium with a flexible and dynamic management system to execute the profiling and portfolio strategy, aided by clearly defined go/no-go decision points. The expected outcome of ERA4TB is a series of highly active, bactericidal, orally available drugs to constitute two or more new combination regimens with treatment-shortening potential ready for Phase II clinical evaluation. These regimens will be compatible with drugs used to treat common comorbidities, such as HIV-AIDS and diabetes, and should impact UN Sustainable Development Goal 3, namely, ending TB by 2030.

With ever-increasing complexity of novel health technologies, Health Technology Assessment (HTA) methodologies have been evolving rapidly. However, there is now a lack of harmonization on the methodological needs of HTA bodies against the varied methodologies and tools. There is a need for a solution that allows for continuous dialogue between HTA bodies and academia, a solid, unified base for implementation of fit-for-purpose methodologies and long-term upskilling on HTA expertise. SUSTAIN-HTA aims to upskill the pan-European HTA body workforce and harmonise HTA expertise via a robust education and training framework that ensures continuous uptake of novel, need-based HTA methodologies. Aligned to the methodological developments as part of the new EU HTA regulation, the project will set up a mechanism for dialogues and interaction between HTA bodies and academia to regularly assess HTA-bodies’ needs in parallel with a methods observatory that ensures up-to-date knowledge of latest HTA methods. Prioritized methods will be piloted within HTA bodies and, after endorsement, implementation will be supported by a harmonized training and education framework that will be established to upskill the HTA experts. A long-term dissemination and communication structure among all stakeholders will be established to guarantee a feedback loop between HTA needs, methods assessment and associated training needs. Via the collaboration of 5 universities, 7 HTA bodies, 2 SMEs and one non-profit organization, SUSTAIN-HTA brings together extensive experience in (coordinating) previous European funded HTA-related projects including HTx, EHDEN, COMED and GetReEal. With this, SUSTAIN-HTA has the background for establishing sustainable business models that ensures continuity of project outcomes and activities in years beyond the project. SUSTAIN-HTA will support European leadership in the HTA field reach HTA bodies across at least 15 European countries with hundreds of people upskilled.

Influenza is a major public health problem. In a conservative estimate, influenza infects annually 60 of the 500 million inhabitants of the EU. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others. The single most important challenge in achieving VE studies for the various influenza vaccines put every year on the European market is the ability of the different stakeholders to work in collaboration. To enable a sustainable network of influenza vaccine VE studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities. This model will ensure scientific independence in the studies and full transparency, allowing different stakeholders to fulfill their needs taking into account their respective obligations and statutes. A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable. Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.

The public-private partnership, READI, seeks to help clinical studies (CS) to finally serve the complete general population, and therefore more patients. To date CS have struggled to recruit and retain participants from diverse backgrounds and communities, such as marginalized or disadvantaged groups (e.g., sexual, gender, age, cultural, and socioeconomic cohorts). The resulting knowledge gaps entrench or increase health disparities. The READI consortium strives to tackle these challenges by fostering a more cohesive and integrated CS ecosystem for underserved (US) and underrepresented (UR) communities. It will actively connect all key stakeholders who can facilitate access to a wide range of patient populations. It will provide these stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of US/UR patients in CS. In addition, it will design, build and implement a digital platform which is patient-centred, sustainable, open and innovative. This will foster improved access to CS information and READI tools, while also supporting patient connections with the created communities. Finally, at least 4 CS will be used for testing the effectiveness of the developed tools and approaches. READI has a three-fold objective: to help US/UR communities overcome CS participation barriers (e.g., lack of information/awareness, mistrust, poor communication, geographic limitations, prejudice), which in turn will improve research of many diseases and conditions, preventative care and treatment effectiveness in different demographic groups, and better serve society. READI’s success will draw from its interdisciplinary, multi-stakeholder, consortium composition of 73 organizations from 18 countries, with key expertise in drug development and CS (design and operations), engagement strategies for US/UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs.