Transdisciplinary research (TDR) projects are increasingly designed and funded with the expectation that they contribute to tackling societal challenges and, consequently, generate societal impact. Yet, the relationship between TDR and societal impact remains complex and insufficiently understood. This study uses the concept of impact practices to offer a processual perspective on how societal impact creation processes unfold within TDR projects. Drawing on insights from practice theory, impact scholarship, and the TDR literature, we conceptualise impact practices as comprising three interrelated building blocks of values, strategies, and networks. Based on a real-time process study, we then identify three interrelated processes in TDR projects through which these impact practices develop: (1) emergence of proto-practices, (2) aligning of values, strategies and networks within these proto-impact practices, and (3) orienting the alignments towards transforming or reproducing societal impact. We show how project participants actively engage in these processes and align and orient a heterogeneity of impact practices within a single project, and how some become collective ways of doing for societal impact, or not. This study contributes to societal impact and TDR scholarship by providing a process model and identifying the key dynamics through which new ways of doing for societal impact creation develop in TDR projects. This is relevant for formative evaluation and management, as it makes the heterogeneous ways through which impact creation processes unfold more visible. In turn, this can contribute to stimulating reflections on impact creation in TDR projects and help make these processes more democratic.

The lack of treatments for patients with a rare disease calls for innovative approaches in drug development. A potential solution to accelerate therapy development is to find new therapeutic uses for existing drugs, i.e. drug repurposing. One way of advancing drug repurposing is to focus on similarities in the molecular and clinical manifestations across multiple rare diseases, by studying drug repurposing candidates in induced pluripotent stem cell (iPSC) models and subsequently grouping diseases in basket trials composed of multiple sub-studies. However, the absence of a single route to navigate the regulatory process, in combination with limited regulatory experience in academia poses a challenge for this approach. To provide more insight into the perceived regulatory challenges and opportunities for basket trials in drug repurposing for rare diseases, a multi-stakeholder dialogue was organised in March 2025. The aim of this dialogue was to contribute to a better alignment of stakeholder perspectives to accelerate therapy development for rare diseases, by identifying and mapping challenges and opportunities in three regulatory scenarios for basket trials in drug repurposing for rare diseases. In total, 28 experts (regulatory, preclinical, clinical, patient, industry, HTA, and other) from eight European countries participated in an interactive online meeting. Thematic analysis of the meeting content showed the most important challenges and opportunities in navigating the regulatory scenarios, covering themes such as preclinical evidence in iPSC models, design of basket trials, involvement of patient organisations, regulatory roles and responsibilities, pharmaceutical product development, HTA and reimbursement, and societal views on repurposed drugs. This multi-stakeholder dialogue highlights the continued need for 1) early regulatory guidance for academic innovators, 2) a (re)calibration of regulatory roles and responsibilities, and 3) early creation of collaborative spaces involving patient organisations, HTA bodies and marketing authorisation holders in the development process to optimize the potential of innovative methods. This multi-stakeholder alignment is essential for the compliant adoption of iPSC models and clinical basket trial designs as promising accelerators for drug repurposing in rare diseases. Not applicable.

Induced pluripotent stem cells (iPSCs) are increasingly used as disease models to accelerate drug repurposing, especially for rare diseases. While ethical and regulatory issues in iPSC research have been widely discussed, little is known about how these challenges are addressed in practice. To provide insights into the current practice, challenges, and opportunities in the governance of research on iPSC-based drug repurposing for rare neurological disorders, semi-structured interviews were conducted with various experts from eight countries in the context of the SIMPATHIC project. The results indicate that this research context requires improved information provision for minors and individuals with cognitive impairment and more clarity regarding commercial use and reporting of findings. Uncertainty in governance procedures hinders collaboration, validation, and clinical translation in iPSC-based drug repurposing. Responsible (re)use of iPSCs requires dynamic, transparent, and participatory governance structures based on shared decision-making with all stakeholders involved.

Medical technologies (MedTech) drive healthcare innovation, yet MedTech companies often struggle to scale up due to institutional barriers. This study identifies these barriers in the Netherlands, examines strategies MedTech scale-ups use to overcome them, and provides recommendations for regulators to lower these barriers. Analyzing 15 companies, we found that entrepreneurs primarily rely on institutional maintenance strategies, such as complying with strict regulations, contextualizing innovations to minimize disruption, and hiring personnel familiar with healthcare norms. They also engage in early forms of institutional creation, including organizing stakeholder alignment meetings and persuading insurers to adjust reimbursement systems. Entrepreneurs also build support by leveraging pioneers, mobilizing social capital, and using evidence-based demonstrations to foster trust and drive normative changes. We observed no strategies aimed at institutional disruption, reflecting the highly regulated nature of healthcare and the critical role of regulations in safeguarding public health. However, we found that building legitimacy through institutional maintenance can create opportunities to influence institutional frameworks over time. Our findings highlight the importance of regulatory flexibility to encourage innovation and collaboration between MedTech entrepreneurs, insurers, and regulators. These insights offer actionable steps to address systemic barriers and foster a supportive environment for scaling MedTech innovations.

This editorial focuses on the diverse studies and frameworks related to the diffusion of innovations, building beyond Everett Rogers' seminal work from 1962. Despite a renewed interest in diffusion research, fragmentation exists as different academic communities work independently with limited cross-referencing. Seeing great advantage in building bridges and exchanging insights across these conceptual and empirical expansions of Rogers, this editorial explores the heterogeneous nature of diffusion, embracing more variety, in terms of innovations types, systems, geographies and pathways. Using “generalisation” as a broad umbrella term that captures the essence of these expansions on diffusion theory, eight building blocks were identified from the literature, offering new research avenues to study diffusion. The special issue encompasses nine articles in which a broader understanding of diffusion is explored. Key lessons include: recognising diffusion as a set of heterogeneous activities involving different innovations, actors, and institutional logics; considering temporal aspects, anticipating repercussions on user groups; and envisioning ethical, legal, and societal impacts for responsible diffusion. These lessons are relevant for policymakers who are increasingly interested in understanding diffusion to address grand challenges. Innovation policy to address challenges calls for new frameworks incorporating transformative diffusion policy measures, which should be built on insights and conceptual frameworks offered by scholars and strategic intelligence provided by decision-makers.

Organizations across the globe are progressively investing in artificial intelligence (AI) innovations to meet today’s healthcare challenges. Meanwhile, public policy increasingly emphasizes the need for these innovations to be ‘scaled’. As scholars emphasize, scaling innovations is never just ‘more of the same’, but requires adapting innovations to local contexts. In this perspective paper, we aim to explore and draw attention to the tensions and possible alignments between standardization and customization that should lead to a responsible scaling of AI in healthcare. We approach responsible scaling building on the notion of socio-technical configurations. Configurations are unique assemblies of technological and non-technological components, including human factors, integrated in different ways to meet particular local requirements. We explore how conceptualizing AI tools and the broader socio-technical ecosystems in which they are integrated as configurations can offer a framework for envisioning possible pathways for responsibly scaling AI. We contend that standardization and customization can be employed synergistically within AI configurations. Standardization can be an important driver of innovation at the level of configurational components of healthcare AI, as well as the interoperability between these components. Thereby, standardization can expand the configurational options that local AI implementations can draw from and lay a foundation for local customization of healthcare AI ecosystems at the architectural level. Accordingly, we propose key considerations for innovators and policymakers to boost the configurability of healthcare AI, and discuss the need for, and challenges of shaping of healthcare AI configurations at the local scale.

New Approach Methodologies (NAMs) for risk assessment of chemicals and pharmaceuticals are widely regarded as essential for phasing out animal testing and advancing next-generation risk assessment. However, despite substantial public investments in research and development (R&D) to develop these NAMs, concerns persist about the limited societal impact of these projects. This study addresses this concern by examining how societal impact is pursued in sixteen large-scale, publicly-funded European R&D projects focused on developing NAMs that integrate in silico and in vitro methods. Drawing on an in-depth analysis of 197 publicly available documents and seven semi-structured interviews, we identify 25 impact activities typically pursued in these projects, which vary in the stakeholders targeted as well as levels of engagement ranging from one-way communication to more interactive approaches such as deliberation and co-production. From these findings, we derive five routes to impact focused on community and capacity building, changing policy and regulation, advancing scientific developments, commercialization and industrial partnerships, and mobilizing civil society. We then analyze how these routes function within projects with a focus on perceived barriers and trade-offs between them. Based on this we offer practical and strategic recommendations for pursuing impact in NAM R&D projects. In particular, we recommend that project coordinators and partners be more reflexive on the pursuit of multiple impact routes in a single project and adopt more co-productionist approaches to stakeholder engagement, beyond those already used in case-study development. We also recommend a stronger focus on engaging civil society, which remains underrepresented in NAM R&D projects.

Social innovation initiatives in the pharmaceutical field seek alternative, collaborative ways to address problems with availability and affordability of medicines. However, these experimental initiatives require legitimacy. Formulating goals is a way of creating and contesting legitimacy, also for social innovation initiatives, yet has not been studied in this context. Based on document analysis (policy reports, news articles and websites) and semi-structured interviews, we investigate what form and role goal formulations take in constructing and contesting the legitimacy of two Dutch social innovation initiatives: one novel coverage arrangement for a rare disease drug and one new manufacturing process for a personalised cancer treatment. We find that actors formulate goals to manage consensus with powerful, independent governance bodies and with those who reserve their judgement concerning the initiative. They also manage differences, highlighting role differentiation within collaborations and emphasising contrasts with outsiders. These findings show the importance of professional identities and the experimental nature of social innovation initiatives. We conclude that formulating goals is used to probe for and attempt to ensure the longevity of social innovation. Working together in diverse partnerships for 'the greater goods' (plural) is thus essential for organising durable social innovation in the European pharmaceutical field .

Background: Emerging technologies such as artificial intelligence (AI) require an early-stage assessment of potential societal and ethical implications to increase their acceptability, desirability, and sustainability. This paper explores and compares 2 of these assessment approaches: the responsible innovation (RI) framework originating from technology studies and the co-design approach originating from design studies. While the RI framework has been introduced to guide early-stage technology assessment through anticipation, inclusion, reflexivity, and responsiveness, co-design is a commonly accepted approach in the development of technologies to support the care for older adults with frailty. However, there is limited understanding about how co-design contributes to the anticipation of implications. Objective: This paper empirically explores how the co-design process of an AI-based decision support system (DSS) for dementia caregivers is complemented by explicit anticipation of implications. Methods: This case study investigated an international collaborative project that focused on the co-design, development, testing, and commercialization of a DSS that is intended to provide actionable information to formal caregivers of people with dementia. In parallel to the co-design process, an RI exploration took place, which involved examining project members'viewpoints on both positive and negative implications of using the DSS, along with strategies to address these implications. Results from theco-design process and RI exploration were analyzed and compared. In addition, retrospective interviews were held with projectmembers to reflect on the co-design process and RI exploration. Results: Our results indicate that, when involved in exploring requirements for the DSS, co-design participants naturally raisedvarious implications and conditions for responsible design and deployment: protecting privacy, preventing cognitive overload,providing transparency, empowering caregivers to be in control, safeguarding accuracy, and training users. However, whencomparing the co-design results with insights from the RI exploration, we found limitations to the co-design results, for instance,regarding the specification, interrelatedness, and context dependency of implications and strategies to address implications. Conclusions: This case study shows that a co-design process that focuses on opportunities for innovation rather than balancingattention for both positive and negative implications may result in knowledge gaps related to social and ethical implications andhow they can be addressed. In the pursuit of responsible outcomes, co-design facilitators could broaden their scope and reconsiderthe specific implementation of the process-oriented RI principles of anticipationand inclusion

BACKGROUND:Although the use of artificial intelligence (AI)-based technologies, such as AI-based decision support systems (AI-DSSs), can help sustain and improve the quality and efficiency of care, their deployment creates ethical and social challenges. In recent years, a growing prevalence of high-level guidelines and frameworks for responsible AI innovation has been observed. However, few studies have specified the responsible embedding of AI-based technologies, such as AI-DSSs, in specific contexts, such as the nursing process in long-term care (LTC) for older adults. OBJECTIVE:Prerequisites for responsible AI-assisted decision-making in nursing practice were explored from the perspectives of nurses and other professional stakeholders in LTC. METHODS:Semistructured interviews were conducted with 24 care professionals in Dutch LTC, including nurses, care coordinators, data specialists, and care centralists. A total of 2 imaginary scenarios about AI-DSSs were developed beforehand and used to enable participants articulate their expectations regarding the opportunities and risks of AI-assisted decision-making. In addition, 6 high-level principles for responsible AI were used as probing themes to evoke further consideration of the risks associated with using AI-DSSs in LTC. Furthermore, the participants were asked to brainstorm possible strategies and actions in the design, implementation, and use of AI-DSSs to address or mitigate these risks. A thematic analysis was performed to identify the opportunities and risks of AI-assisted decision-making in nursing practice and the associated prerequisites for responsible innovation in this area. RESULTS:The stance of care professionals on the use of AI-DSSs is not a matter of purely positive or negative expectations but rather a nuanced interplay of positive and negative elements that lead to a weighed perception of the prerequisites for responsible AI-assisted decision-making. Both opportunities and risks were identified in relation to the early identification of care needs, guidance in devising care strategies, shared decision-making, and the workload of and work experience of caregivers. To optimally balance the opportunities and risks of AI-assisted decision-making, seven categories of prerequisites for responsible AI-assisted decision-making in nursing practice were identified: (1) regular deliberation on data collection; (2) a balanced proactive nature of AI-DSSs; (3) incremental advancements aligned with trust and experience; (4) customization for all user groups, including clients and caregivers; (5) measures to counteract bias and narrow perspectives; (6) human-centric learning loops; and (7) the routinization of using AI-DSSs. CONCLUSIONS:The opportunities of AI-assisted decision-making in nursing practice could turn into drawbacks depending on the specific shaping of the design and deployment of AI-DSSs. Therefore, we recommend considering the responsible use of AI-DSSs as a balancing act. Moreover, considering the interrelatedness of the identified prerequisites, we call for various actors, including developers and users of AI-DSSs, to cohesively address the different factors important to the responsible embedding of AI-DSSs in practice.

The Responsible Innovation (RI) approach aims to transform research and development (R&D) into being more anticipatory, inclusive, reflective, and responsive. This study highlights the challenges of embedding RI in R&D practices. We fostered collective learning on RI in a socially assistive robot development project through applying participatory action research (PAR). In the PAR, we employed a mixed-methods approach, combining interviews, workshops, and online questionnaires, to collectively explore opportunities for RI, and elicit team member perceptions, opinions, and beliefs about RI. Our PAR led to some modest yet purposeful, deliberate efforts to address particular concerns regarding, for instance, privacy, control, and energy consumption. However, we also found that the embedding of RI in R&D practices can be hampered by four partly interrelated barriers: lack of an action perspective, the noncommittal nature of RI, the misconception that co-design equals RI, and limited integration between different R&D task groups. In this paper, we discuss the implications of these barriers for R&D teams and funding bodies, and we recommend PAR as a solution to address these barriers.

Background Emerging technologies such as artificial intelligence (AI) require an early-stage assessment of potential societal and ethical implications to increase their acceptability, desirability, and sustainability. This paper explores and compares 2 of these assessment approaches: the responsible innovation (RI) framework originating from technology studies and the co-design approach originating from design studies. While the RI framework has been introduced to guide early-stage technology assessment through anticipation, inclusion, reflexivity, and responsiveness, co-design is a commonly accepted approach in the development of technologies to support the care for older adults with frailty. However, there is limited understanding about how co-design contributes to the anticipation of implications. Objective This paper empirically explores how the co-design process of an AI-based decision support system (DSS) for dementia caregivers is complemented by explicit anticipation of implications. Methods This case study investigated an international collaborative project that focused on the co-design, development, testing, and commercialization of a DSS that is intended to provide actionable information to formal caregivers of people with dementia. In parallel to the co-design process, an RI exploration took place, which involved examining project members’ viewpoints on both positive and negative implications of using the DSS, along with strategies to address these implications. Results from the co-design process and RI exploration were analyzed and compared. In addition, retrospective interviews were held with project members to reflect on the co-design process and RI exploration. Results Our results indicate that, when involved in exploring requirements for the DSS, co-design participants naturally raised various implications and conditions for responsible design and deployment: protecting privacy, preventing cognitive overload, providing transparency, empowering caregivers to be in control, safeguarding accuracy, and training users. However, when comparing the co-design results with insights from the RI exploration, we found limitations to the co-design results, for instance, regarding the specification, interrelatedness, and context dependency of implications and strategies to address implications. Conclusions This case study shows that a co-design process that focuses on opportunities for innovation rather than balancing attention for both positive and negative implications may result in knowledge gaps related to social and ethical implications and how they can be addressed. In the pursuit of responsible outcomes, co-design facilitators could broaden their scope and reconsider the specific implementation of the process-oriented RI principles of anticipation and inclusion.

To arrive at viable eHealth applications, it is important that future users are involved in research projects. In practice, however, it is difficult to involve potential users and keep them involved. In a multiple-case study, we investigate ten eHealth projects in which design researchers and healthcare researchers worked together. We focus on how they involved potential users and kept them involved. Both domains have a rich tradition of involving potential users and see their involvement of potential (future) users in the early stages of innovation as essential. Therefore it is interesting to investigate projects in which design researchers and healthcare researchers intensively work together. We discovered seven strategies to promote the involvement of potential users in eHealth research projects: (1) use research methods based on building personal relationships; (2) build trust before introducing research methods; (3) facilitate the preconditions around the moments of involvement; (4) facilitate by introducing a prototype as a boundary object; (5) choose the method that fits the research context; (6) integrate the values behind the eHealth tool into the research method; (7) involve proxies instead of the potential users. These strategies may guide future projects where design researchers and healthcare researchers work together with potential users.Keywords: User involvementresearchdesignhealthcareeHealth AcknowledgementsThe authors would like to thank all interviewees and the project team of the overarching project of the ‘Create Health’ program.Authors’ contributionsW.v.B, W.B., and D.A. conceptualized the study. W.v.B. and M.Z. interviewed the respondents. W.v.B. analysed the data. All authors (W.v.B., E.H.M.M., D.A., W.B., G.v.d.V., and M.Z.) contributed to the final version and read and approved the final manuscript.Disclosure statementNo potential conflict of interest was reported by the author(s).Data availability statementThe dataset analysed and data extraction tools used during the current study are available from the corresponding author on reasonable request.Additional informationFundingThis work was supported by the Netherlands Organization for Health Research and Development (ZonMW) under Grant [443002001].Notes on contributorsWilke van BeestWilke van Beest works as a researcher at the Research group Research Competence at the University of Applied Sciences Utrecht. Her research focuses on the impact of practice-based research. Since 2018, she conducts her PhD project at Copernicus Institute of Sustainable Development at Utrecht University. Her PhD work focuses on the implementation of self-management health innovations.Wouter P. C. BoonWouter P.C. Boon is an associate professor in Innovation and life sciences at Copernicus Institute of Sustainable Development at Utrecht University. His research in the field of innovation studies focuses on the dynamics and governance of emerging technologies in science-based sectors, such as life sciences and healthcare. The theoretical focus of his work is on the role of user innovations, demand-side innovation policy, and markets in the context of transitions.Daan AndriessenDaan Andriessen is professor of Research Competence at University of Applied Sciences Utrecht. He specializes in optimizing the impact of practice-based research and the competence development of researchers at universities of applied sciences. His mission is to support researchers in doing research that matters; practice-based research that contributes to the development of knowledge, people, products, and organizations. He has a special interest in the dilemma between rigour and relevance.Marieke ZielhuisMarieke Zielhuis works as a researcher at the Research group Research Competence at the University of Applied Sciences Utrecht. She is especially interested in the collaboration between research and practice partners. Since 2019, she conducts her PhD project at Delft University of Technology. This PhD work focuses on the challenges that arise when developing knowledge for design practice within academic design research projects.Gerrita van der VeenGerrita van der Veen is professor Marketing & Customer Experience at the Research Institute Digital Business & Media of the Utrecht University of Applied Sciences. Her mission is to give direction and elaboration to important issues of innovation in a digital economy together with professional practice and education. Her research focuses on Brand- & Innovation Management and Marketing Technology.Ellen H. M. MoorsEllen H.M. Moors is professor of Innovation and Sustainability at the Copernicus Institute of Sustainable Development of Utrecht University. Her research focuses on the dynamics and governance of health and life sciences innovations, the role of users and institutions in emerging technologies and sustainable or responsible health innovation models.

BACKGROUND:Widespread artemisinin resistance in Africa could be catastrophic when drawing parallels with the failure of chloroquine in the 1970s and 1980s. This article explores the role of anti-malarial market characteristics in the emergence and spread of arteminisin resistance in African countries, drawing on perspectives from Burkina Faso. METHODS:Data were collected through in-depth interviews and focus group discussions. A representative sample of national policy makers, regulators, public and private sector wholesalers, retailers, clinicians, nurses, and community members were purposively sampled. Additional information was also sought via review of policy publications and grey literature on anti-malarial policies and deployment practices in Burkina Faso. RESULTS:Thirty seven in-depth interviews and 6 focus group discussions were conducted. The study reveals that the current operational mode of anti-malarial drug markets in Burkina Faso promotes arteminisin resistance emergence and spread. The factors are mainly related to the artemisinin-based combination therapy (ACT) supply chain, to ACT quality, ACT prescription monitoring and to ACT access and misuse by patients. CONCLUSION:Study findings highlight the urgent requirement to reform current characteristics of the anti-malarial drug market in order to delay the emergence and spread of artemisinin resistance in Burkina Faso. Four recommendations for public policy emerged during data analysis: (1) Address the suboptimal prescription of anti-malarial drugs, (2) Apply laws that prohibit the sale of anti-malarials without prescription, (3) Restrict the availability of street drugs, (4) Sensitize the population on the value of compliance regarding correct acquisition and intake of anti-malarials. Funding systems for anti-malarial drugs in terms of availability and accessibility must also be stabilized.

This study investigates categories and categorization strategies in the transition towards sus-tainable diets. We look at the rise of meat substitutes and understand the meat substitute category as a hybrid one, covering products that are to replace meat while implicitly appealing to vege-tarian/vegan diets. The category is negatively defined, solely and explicitly indicating the product to be substituted. The category's fuzzy nature presents an innovation challenge for producers. We investigate the strategies of nine Dutch meat substitute producers that seek to resemble meat along five dimensions. We conclude that by privileging meat resemblance innovation strategies, most producers tend to 'fit and conform' to the meat regime, largely copying dominant pro-duction and consumption practices. However, we also show that, as a hybrid category that is negatively defined, the meat substitute category provides opportunities for more radical in-novations that have the potential to 'stretch and transform' the regime in the longer run.

BACKGROUND:This study investigates the processes regarding changing malaria treatment policies in Vietnam. Moreover, it explores the feasibility of introducing triple artemisinin-based combination therapy (TACT) in Vietnam to support the national malaria control and elimination plan.METHODS:Data were collected via 12 in-depth interviews with key stakeholders, combined with a review of policy documents.RESULTS:TACT is considered as a useful backup strategy in case future treatment failures with current artemisinin-based combination therapy (ACT) would occur. Moreover, TACT is also considered as a promising strategy to prevent the re-establishment of malaria. However, regulatory procedures and implementation timelines for TACT were expected to be lengthy. Therefore, strategies to engage national decision-makers, regulators, and suppliers should be initiated soon, stipulating the benefits of TACT deployment. In Vietnam, a procedure to apply for an import permit without registration that has previously been applied to the introduction of artesunate-pyronaridine was proposed to accelerate the introduction of TACT. Global-level support through the World Health Organization recommendations and prequalification were considered critical for supporting the introduction of TACT in Vietnam.CONCLUSIONS:Appropriate approach strategies and early stakeholder engagement will be needed to accelerate the introduction of TACT in Vietnam.

The primary purpose of this study was to assess the translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system (CNS) active drugs. As a part of this, IBs were reviewed on reporting quality. Investigator's Brochures (IBs) of studies performed at the Centre for Human Drug Research (CHDR) reporting statistically significant results of CNS activity related to the drug's mechanism of action were included. The quality of IBs was assessed based on the presence of a rationale for the chosen animal model, completeness of pharmacokinetic (PK) results in reporting and internal validity information of the preclinical evidence. The IB-derisk tool was used to generate preclinical and early clinical data overviews data. For each compound, the overlap between pharmacologically active dose ranges and well-tolerated levels was calculated for three pharmacokinetic (PK) parameters: human equivalent dose (HED), maximum plasma concentration (Cmax) and area under the curve (AUC). Twenty-five IBs were included. In general, the quality of reporting in IBs was assessed as poor. About a third of studies did not explore the entire concentration-effect curve (pre)clinically. Single dose tolerability ranges were most accurately predicted by Cmax. Human equivalent dose and AUC were the best predictors of pharmacologically active ranges. Tolerable and pharmacologically active dose ranges in healthy volunteers can be reasonably well predicted from preclinical data with the IB-derisk tool. The translatability of preclinical studies can be improved by applying a higher reporting standard in IBs including comparable PK measurements across all preclinical and clinical studies.

BACKGROUND:This is a qualitative study to identify implementation challenges for deploying triple artemisinin-based combination therapy (TACT) in the Greater Mekong Subregion (GMS) of Southeast Asia and to explore strategies to overcome these challenges.METHODS:In-depth interviews were conducted in three countries that have repeatedly been confronted with ACT failures: Cambodia, Vietnam, and Lao PDR. Thirty-nine key stakeholders in the healthcare systems in these countries were interviewed. One participatory workshop was conducted in Cambodia, where scenarios for potential TACT deployment were discussed.RESULTS:The results section is organized around four strategic themes that emerged from the data: policy support, data and evidence, logistics and operation, and downstream engagement. The study revealed that countries in the GMS currently rely on ACT to eliminate Plasmodium falciparum malaria by 2025. TACT is, however, considered to be a useful backup strategy in case of future treatment failures and to prevent the re-establishment of malaria. The study showed that a major challenge ahead is to engage decision makers and healthcare providers into deploying TACT, given the low case incidence of falciparum malaria in the GMS. Interview respondents were also skeptical whether healthcare providers would be willing to engage in new therapies for a disease they hardly encounter anymore. Hence, elaborate information dissemination strategies were considered appropriate and these strategies should especially target village malaria workers. Respondents proposed several regulatory and programmatic strategies to anticipate the formation of TACT markets in the GMS. These strategies include early dossier submission to streamline regulatory procedures, early stakeholder engagement strategies to shorten implementation timelines, and inclusion of TACT as second-line therapy to accelerate their introduction in case they are urgently needed.CONCLUSIONS:This paper presents a qualitative study to identify implementation challenges for deploying TACT in the GMS and to explore strategies to overcome these challenges. The findings could benefit researchers and decision makers in strategizing towards potential future deployment of TACT in the GMS to combat artemisinin and partner drug resistance.

New magnetic resonance imaging (MRI) techniques that offer faster scanning and potential artificial intelligence-assisted interpretation and diagnosis can significantly impact existing workflows in radiology. In a qualitative study embedded within a responsible research and innovation design, we investigate the development and potential implementation of quantitative MRI. We aim to investigate postdigital MRI futures, covered by scenarios of potential workflows, as well as the resulting implications for professions and related education involved in the MRI process. Furthermore, we examine the related and changing responsibilities, more specifically reflecting on ‘forward-looking responsibilities’. Through expert interviews ( n = 20) and a focus group, stakeholder perspectives on the future of quantitative imaging techniques were explored. During a subsequent co-creation workshop and another focus group, stakeholders reflected on future scenarios in quantitative MRI. Our study shows that a proactive and future-oriented investigation of the influence of emerging technologies on potential workflows and subsequent changes in expertise and roles help in gaining or increasing awareness about the wider impact of a technology developed to contribute to faster and quantitative MRI exams. We argue that anticipating postdigital worlds by reflecting on future responsibilities through the co-creation of imaginaries can help making uncertain futures tangible in other ways.

Against the backdrop of a failing vaccine innovation system, innovation policy aimed at creating a COVID-19 vaccine was surprisingly fast and effective. This paper analyzes the influence of the COVID-19 landscape shock and corresponding innovation policy responses on the existing vaccine innovation system. We use document analysis and expert interviews, performed during vaccine development. We find that the sharing of responsibility between public and private actors on various geographical levels, and the focus on accelerating changes in the innovation system were instrumental in achieving fast results. Simultaneously, the acceleration exacerbated existing societal innovation barriers, such as vaccine hesitancy, health inequity, and contested privatization of earnings. Going forward, these innovation barriers may limit the legitimacy of the vaccine innovation system and reduce pandemic preparedness. Next to a focus on acceleration, transformative innovation policies for achieving sustainable pandemic preparedness are still urgently needed. Implications for mission-oriented innovation policy are discussed.