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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 .

Introduction It is commonly accepted that technological innovations in sports have dramatically improved athletic abilities and are crucial for maximizing performance for both individuals and organizations. Although innovations have improved performance in a number of sports, they also play a controversial role. To better understand these controversies this research looks into the process of legitimization of performance enhancing equipment innovations from an institutional perspective by combining concepts of Strategic Action Field theory and innovation processes. Theory Strategic Action Field (SAF) theory describes three phases fields go through in resolving controversies and define actor roles present in the field; dominant actors, challengers and governance units. Innovation theory adds to this by distinguishing, users, producers and institutional actors. Within a field actors act strategically to maintain or strengthen their position in the field. During contentions these actors engage in strategic action to influence the legitimacy of new technologies. To better understand these processes this research distinguishes between three types of legitimacy and describes five strategies actors use to influence this legitimacy. Methods This research used a comparative multiple case study design looking into skinsuit usage in Skeleton, Cycling and Swimming. News articles and internet data were used as primary data sources for analysis. For each case the analysis consisted of five consecutive steps; open coding of the data, drafting a timeline, actor role analysis, legitimacy analysis, and a strategy analysis Lastly, all cases were compared based on the preceding analytical steps. These steps are further elaborated on below. Results All three cases followed different timelines. In all cases new technologies were introduces by a dominant actors through a user-producer interaction while opposition came from both dominant as challenger actors. Furthermore, in all cases the

Greenwashing is an increasing problem in our society as it is hard to detect due to increasingly sophisticated greenwashing techniques and an asymmetry of information between firms and the general public. Firms make claims regarding their corporate sustainability in their CSR reports, which might be genuine or could be greenwashed. When firms engage in greenwashing their symbolic actions (“the green talk”) do not align with their substantive actions on environmental issues (“the green walk”). These substantive actions are measured by examining patents which are an indicator of technological innovations. We examine 134 firms in the European energy sector to determine if they are “walking the talk”. To get a better understanding of which firms are more likely to engage in greenwashing this master thesis investigates which firm characteristics influence the extent of greenwashing in CSR reports. We obtain this objective using three steps. First, we define the extent of greenwashing as a discrepancy between symbolic and substantive actions. Second, we find three theoretically informed firm characteristics, which were described as important determinants of greenwashing and we formulate corresponding hypotheses for them. Third, we propose a new measurement approach to test these hypotheses based on the discrepancy between symbolic and substantive actions using state-of-the-art machine learning techniques. This thesis demonstrates that the measurement approach manages to detect discrepancies between the symbolic and substantive actions for firms operating in the European energy sector. We find that neither of the three formulated firm characteristics directly relate to the extent of greenwashing, indicating that greenwashing does not seem to be a systematic phenomenon for our dataset. We also find that firms mainly engage in technological innovation with regards to solar energy, wind energy, and the reduction of emissions and toxic gasses. Moreover, we discover that the ma

01 juli 2020, Contains fulltext : 220591.pdf (Publisher’s version ) (Open Access), BACKGROUND AIMS: Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies. METHODS: We conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€). RESULTS: The framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to he

Contains fulltext : 203007.pdf (publisher's version ) (Open Access), BACKGROUND: To help people with intellectual disabilities lead a more independent life, it is important to promote their self-management. This study evaluated the effectiveness of a self-management training for people with intellectual disabilities directed at independent functioning in daily life. METHOD: In the training, 17 people with intellectual disabilities worked on personal self-management goals covering a wide range of everyday affairs. Primary outcome measures focused on goal attainment, independence and support needs. Moreover, outcomes regarding psychopathological behaviour and quality of life were explored. Data were collected before and at the start of the training, and 3, 6, 9 and 12 months later. RESULTS: The training contributed to the attainment of self-management goals and to the reduction in support needs (p < 0.01). There were no changes in independence, psychopathological behaviour and quality of life. CONCLUSIONS: Results indicate that the training supports people with intellectual disabilities to self-manage their daily affairs.

The theory of social judgements of organizations received considerable attention in organizational literature during the last decade. Studies focused on demarcating organizational legitimacy, reputation and status and how these affect decision-making. Judgements about organizational reputation are used as heuristic to estimate future product quality based on previous interactions with the organization holding the reputation. In management literature, organizational reputation is threefold, divided into familiarity (being known), expectations about future outcomes based on prior performance (being known for something) and general impressions about the organization (generalized favorability). Studies proved that when uncertainty exists about product outcome, judgements about the organizational reputation are used to aid decision-making. This is especially relevant for industries were product quality cannot be assessed before large-scale usage. The pharmaceutical industry matches these conditions and is researched extensively, primarily focusing on the case of the US Food and Drug Administration (FDA). These studies proved that being known and generalized favorability facilitate decision-making, but largely neglected the effects of being known for something. This study aims to provide insights in the relationship between three types of organizational reputation and drug review times, by empirically testing them in the context of new drug approvals in Europe. This allowed replication of the variables used in research on the FDA, while extending to newly introduced indicators that measured the applicants prior performance regarding quality issues and product discontinuities. Hence, a dataset was composed with 488 marketing authorization application review procedures and reputational indicators of the applicants. All procedures received approval by the EMA between 1995 and 2017 and had comparable levels of product uncertainty. Using negative binomial and cox proportional

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management.

Item does not contain fulltext, BACKGROUND: People with intellectual disabilities have increasing difficulties managing their daily affairs. This study examined the effectiveness of a staff training, which teaches staff to promote self-management in people with intellectual disabilities. METHOD: Effectiveness was assessed with questionnaires addressing clients' (n = 26) independence and self-reliance, support needs and challenging behaviour, using a pre-posttest control group design. Additionally, focus groups were conducted with trained staff members 6 months after the training. RESULTS: In the long term, the intervention group showed a significant increase in independence and self-reliance, in contrast to the comparison group. No effect was found on support needs and challenging behaviour. Trained staff members reported limited benefits of the training, but had noticed changes in their attitude and method of working afterwards. CONCLUSIONS: Further self-management research is required to investigate how independence and self-reliance can be promoted more effectively in this population. Future trainings should carefully consider their content, format, and implementation.

Type 2 diabetes is a growing problem worldwide, and is driven by preventable risk factors such as obesity, unhealthy diets and sedentary life-styles. In light of recognition of these risk factors, prevention-based and life-style based interventions are being developed, directly competing with the incumbent technological trajectory of pharmacological treatment. Controversy on the value of each of the technological trajectories exists, however, which prompted this research. Previous research has analyzed technological trajectories, and other studied also analyzed technological assessment frames of actors, but a knowledge gap remains on how these actors and their frames influence technological trajectories in their development. This thesis combined theory on technological trajectories, technological assessment frames and different actor group relations to technologies to create an overview of the competing landscape of technological trajectories for type 2 diabetes. This was done by gathering publicly available publication data from journals, newswires and publications by actors themselves. Speech-acts were then found in the publication data, based on which technological assessment frames were constructed on each of the four technological trajectories for each actor group. This study confirmed the roles of actor groups as proposed in previous theory, with producers driving technological trajectories, institutions promoting challengers and users filling in a more neutral role. Results also showed that the incumbent trajectory of pharmacological treatment evolves and adapts to novel technologies, while challenging trajectories hardly focus on the incumbent trajectory at all. These challenging trajectories remain more heterogeneous, and seem to experience their own era of ferment, which may serve as an indicator for technological discontinuity in the field. This should be investigated further, however.

This study aims to explore the connection between institutional logics and technological frames to understand the literature gap why different actor groups within a social system make sense of technologies differently. These differences in sensemaking induce different beliefs among actor groups, which results in different perceptions about the legitimacy of a technology. This can cause social contestation where actor groups with opposite beliefs engage in collective sensemaking to predominate a common understanding. This phenomenon is researched in the context of the debate surrounding the adoption of artificial turf in Dutch football. This adoption shows dissimilar rates between amateur and professional adopters and contains quantum jumps of adoption at the professional level. This led to various kinds of speech acts in media by different groups of actors to show or convince others of their beliefs regarding artificial turf at the amateur or professional level in football. A media content analysis was done to study these speech acts in Dutch regional and national newspapers by retrieving these newspapers from the LexisNexis database. By using qualitative and quantitative methods, the concepts of actor groups, evaluation criteria, institutional logics, and beliefs were defined and linked to each other to identify how actor groups differ in terms of the institutional logics and evaluation criteria they connect that determine their beliefs. The findings of this thesis show that the concepts of institutional logics, evaluation criteria, and actor groups were multilayered and that different actor groups articulated a different set of speech acts. These speech acts could be classified by using institutional logics and evaluation criteria. Over time, six different periods were identified that could be characterized by different speech acts of different actor groups and different developments. From the results of this analysis, a model was created that identifies the proce

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management.

This study analyses the difference in hurdle experience and system building activities by Dutch CDSS developers and how they influence the innovation system. By making use of a priori argument, this study addressed if public and private developers carrying out different activities, aiming for products with different socio-characteristics and therefore striving for a different institutional set-up. Theoretically, this study combined several analytical perspectives from the innovation literature to formulate a comprehensive view for researching the expected interactions. Using real-life insights of eighteen semi-structured with developers and institutional actors, this study found that both developers produce a mix of CDSS and carry out overlapping system building activities. The results showed that public developers only experience substantially less market-economic related hurdles and are better able to influence the system with successful activities. Yet, activities aimed at strengthening the guidance of the search and legitimacy creation were rather unsuccessful, explaining the formative phase of the innovation system. Given this and the aim for a mix of product types, explains the absence of the expected distinction between public and private developers strive. Overall, the findings of the study are framed within theoretical implications for similar analysis and managerial implications for the Dutch CDSS innovation system.

Firms need to implement major changes to reduce their CO₂ footprint. One method to incentivise them, is with the CO₂-Performance Ladder. The CO₂-Performance Ladder is a voluntary instrument indirectly empowered by financial benefits in tenders. To get a certificate on the CO₂-Performance Ladder, firms need to comply with requirements, of which requirements 4D and 5D demand companies to take initiative in reducing CO₂ emissions in their sector. The SKAO has little insight in how firms respond to these requirements, and what kind of initiatives are taken. However, the SKAO does suspect that some firms comply with minimal effort, and that some firms go beyond requirements. Furthermore, in literature little is known about how firms respond to unique policy such as the CO2PL. To provide insight in this knowledge gap, we pose the following research question: how do firms respond to meet the requirements 4D and 5D of the CO₂-Performance Ladder in the Netherlands? To research this, we used and extended the framework of Wesseling et al. (2015) on firm response to public innovation policy. Furthermore, sixteen semi structured interviews were conducted and we were able to categorize all companies in the framework. However, we had to extend the framework to fully comprehend all empirical findings. We argue that firms use a combination of compliance and influence strategies, in which we discern between value maintaining or value creating activities. From the comparative case study, we found that in line with theory most firms use either a combination of value maintaining strategies; non-innovation combined with defensive influence strategies and start an initiative for legislation or relabel a client order, or use a combination of value creating strategies; incremental or radical innovation strategies combined with a proactive influence strategy and are intrinsically motivated or start an initiative for the business model. However, we found some firms do not follow what theory s