Innovative Medicines Initiative

The recent advancements in artificial intelligence (AI), and data science more broadly, have led to a proliferation of new methods and tools, such as machine learning (ML), that are used in all kinds of scientific research, from biomedical research through to environmental and education research. Research ethics review bodies are increasingly required to review AI research protocols that cover these different fields of enquiry. Questions have been raised regarding the appropriateness of existing ethics governance principles, practices, and processes to deal with the ethical challenges that AI and data science are introducing to research. Universities and research institutions across the world are trying to understand how to translate and practically implement broad AI ethical principles into research ethics governance guidelines and processes. In this article, we report on an expert stakeholders’ workshop organised at the University of Oxford as part of the process of reviewing its ethics governance for AI research. We describe the workshop and present the reflections and recommendations that emerged from it. The aim of the article is to share the approach taken by the University of Oxford CUREC in reviewing its ethics governance processes, and the insights gained with the broader research community, as a way of contributing to this scarce body of literature, facilitating further dialogue, promoting debate and collaboration on this important issue.

Children deserve health solutions, including medicines, medical devices and diagnostics, that are adapted to their needs. They should not be left behind when it comes to benefitting from innovations. The introduction of paediatric legislation in the EU and US in the 2000s dramatically changed the regulatory environment by fostering the development of medicines for children. However, the development of paediatric medicines remains challenging, and many needs remain unmet. When it comes to medical devices and in vitro diagnostics (IVDs), very few are designed and intended specifically for use in children, leading doctors to use adult devices and adapt them to fit children. To address the scientific, technical, and operational challenges related to paediatric development, multi-stakeholder collaboration is key. The European public-private partnerships the Innovative Health Initiative (IHI), and its predecessor the Innovative Medicines Initiative (IMI), contribute to advancing paediatric research by bringing together the private health industry sectors and public partners including academia, healthcare providers, patients and carers, regulators, and health technology assessment bodies. Several of their large collaborative research projects have already produced significant results that are optimising the development of paediatric medicines. This article looks at these achievements and discusses opportunities for further public-private collaborative research to boost the development of innovative health solutions that address specifically all children's needs.

"Welcome to 'Makanuna', our place … home of our inner spirit A trove of things crafted by our hands … is waiting for you to find inside this space." Malak Alaa Eldeen, 2023 Makanuna Al-Khalifa was a participatory placemaking project empowering adolescents in al-Khalifa neighbourhood in historic Cairo to redesign their local public spaces. Through 2021-2022 workshops, around 20 youth aged 13-18, including Malak Alaa Aldeen, upcycled solid and organic waste into outdoor furniture, games, and compost for al-Khalifa Park. A key output was Malak’s poem “The Story of Makanuna” with illustrations by her sister Fatma Alaa Eldeen, also a workshop participant. In vivid verses, the 17-year-old welcomes readers to “Makanuna” - Arabic for “Our Space” - home to their creativity and handcrafted items. She describes making a gazebo “formed from three triangles” of repurposed plastic bottles and rope, illuminated to resemble “a rainbow”, delighting all who see it. Inspired, they crafted five more lighting units “with bold colours and innocent hands.”The poem conveys their determined spirit driving this unique space’s creation through hard work “from our plans.” Malak radiates pride in resourceful designs like a recycling bin filled with bottles containing natural materials from the park. Her closing words capture their ownership: “Here is our place and our story. So, what do you think of our idea in all its glory?”Empowering youth to transform underutilized areas fostered creativity, environmental stewardship and belonging. Building on this, Malak, Fatma and other core team members launched “Makanuna Initiative” to pursue placemaking further. Malak now voices this youth-led initiative’s junior team, aiming to inspire wider involvement. Malak’s poem and Fatma’s illustrations powerfully capture their sustainable accomplishments. This highlights the initiative’s origins in the Al-Khalifa workshops through adolescent participants who helped catalyse Makanuna’s growth from a local project into a youth-led movement.

This study was conducted to determine the levels of Patients' spiritual well-being (SWB) and self-care agency (SCA) of patients receiving chemotherapy with a port catheter. It was a correlational and observational study. Data were collected between December 2021 and March 2022. The sample was 88 people. Of the participants; 59.1% were women, 88.6% were married, 38.6% were primary school graduates, 47.7% were unemployed, and 51.1% had income equal to their expenses. Furthermore, 38.6% patients had breast cancer diagnosis and 52.3% did not have any chronic diseases. Both scale scores were affected by different variables and there was a positive correlation between SCA and SWB. Better SWB positively affected SCA. Patient age and duration after cancer diagnosis affected SCA and SWB. Notably, SCA and SWB levels of the patients may change with age and disease progression, and patients should also be monitored in this respect.

ObjectiveTo investigate vaccine hesitancy leading to underimmunization and a measles outbreak in Rwanda and to develop a conceptual, community-level model of behavioural factors.MethodsLocal immunization systems in two Rwandan communities (one recently experienced a measles outbreak) were explored using systems thinking, human-centred design and behavioural frameworks. Data were collected between 2018 and 2020 from: discussions with 11 vaccination service providers (i.e. hospital and health centre staff); interviews with 161 children’s caregivers at health centres; and nine validation interviews with health centre staff. Factors influencing vaccine hesitancy were categorized using the 3Cs framework: confidence, complacency and convenience. A conceptual model of vaccine hesitancy mechanisms with feedback loops was developed.FindingsA comparison of service providers’ and caregivers’ perspectives in both rural and peri-urban settings showed that similar factors strengthened vaccine uptake: (i) high trust in vaccines and service providers based on personal relationships with health centre staff; (ii) the connecting role of community health workers; and (iii) a strong sense of community. Factors identified as increasing vaccine hesitancy (e.g. service accessibility and inadequate follow-up) differed between service providers and caregivers and between settings. The conceptual model could be used to explain drivers of the recent measles outbreak and to guide interventions designed to increase vaccine uptake.ConclusionThe application of behavioural frameworks and systems thinking revealed vaccine hesitancy mechanisms in Rwandan communities that demonstrate the interrelationship between immunization services and caregivers’ vaccination behaviour. Confidence-building social structures and context-dependent challenges that affect vaccine uptake were also identified.

A scholarly article by authors David Coley, Noorullah Kuchai, and Jie Wang, Francis Moran, Kemi Adeyeye, Tonja Klanšek, Shahidul Islam, Sam Woodbridge published in The International Journal of Architectonic, Spatial, and Environmental Design

The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Union and the European pharmaceutical industry. Born of the necessity to foster collaboration between different stakeholders in order to address growing challenges in bringing new medicines to market and the rapidly evolving healthcare landscape, IMI has successfully delivered the radical collaboration needed to address these challenges. In this article we reflect on some of the major achievements of the programme by highlighting a few of the key projects funded and the progress they have made, as well as some of the lessons learnt in delivering such an ambitious partnership. Those that drove the foundation of IMI recognized that to address these challenges required not just ambitious scientific approaches, but also an awareness of societal needs. Therefore, actors from beyond the traditional pharmaceutical research communities would be needed. One of the key successes of IMI has been to foster radical collaboration between diverse public and private partners of all types, including large pharmaceutical companies, SMEs, regulators, patient organizations and public research institutions. It has achieved this by being a neutral platform where all partners are bound by the same rights and responsibilities. Since it began there has been an evolution in the understanding of what is considered “pre-competitive,” resulting in IMI projects now addressing all of the steps within the pharmaceutical development value chain. With this expansion in the types of projects supported by IMI, different actors from beyond the traditional pharmaceutical research family have been attracted to participate, enriching further the collaboration at the heart of the programme. Finally, such a complex programme brings with it challenges, and we reflect on some of the important learnings that should be applied to future collaborative models to ensure that they are as successful as possible and deliver the expected impact.