Ixekizumab Citrate-Free Formulation : Results from Two Clinical Trials

Introduction: Subcutaneous (SC) injection is a common route of drug administration; however, injection site pain (ISP) might create a negative patient experience. We evaluated ISP, bioequivalence, and overall safety of the citrate-free (CF) formulation of ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A. Methods: Two phase 1, single-blind studies were conducted in healthy participants. The crossover study A (NCT03848403) evaluated pain intensity on injection as measured by visual analog scale of pain (VAS) scores. Subjects (N = 70) were randomized 1:1:1 at the beginning to three possible treatment sequences and received a 1 mL SC injection of the three formulations sequentially in the abdomen on days 1, 8, and 15, respectively. A mixed-effects repeated measures analysis model was used to analyze VAS score by time post-injection. Study B (NCT04259346) evaluated the bioequivalence of a single 80 mg dose of CF formulation compared to the original commercial formulation. Subjects (N = 245) were randomized 1:1 to either commercial or CF formulation and received a single SC injection into the abdomen, arm, or thigh. Results: Primary endpoint was achieved in both studies. In study A, least-squares mean (LSM) difference of VAS scores immediately post injection between commercial (n = 61) and CF formulation (n = 63) was − 21.7 (p < 0.0001), indicating a lower degree of pain associated with CF formulation. In study B, bioequivalence of the CF formulation was established as 90% CIs for the ratio of geometric LSM AUC, AUC, and C between treatments were contained within the prespecified limits of 0.8 and 1.25. Except for less ISP in the CF formulation, overall safety profile was comparable. Conclusion: Ixekizumab CF formulation proved to be bioequivalent, was associated with less ISP, and had no other notable differences in the safety profile compared to the original commercial formulation. Trail Registration: ClinicalTrials.gov identifier NCT03848403, NCT04259346

Research and Innovation As a Catalyst For Food System Transformation

Background Food systems are associated with severe and persistent problems worldwide. Governance approaches aiming to foster sustainable transformation of food systems face several challenges due to the complex nature of food systems. Scope and approach In this commentary we argue that addressing these governance challenges requires the development and adoption of novel research and innovation (R&I) approaches that will provide evidence to inform food system transformation and will serve as catalysts for change. We first elaborate on the complexity of food systems (transformation) and stress the need to move beyond traditional linear R&I approaches to be able to respond to persistent problems that affect food systems. Though integrated transdisciplinary approaches are promising, current R&I systems do not sufficiently support such endeavors. As such, we argue, we need strategies that trigger a double transformation – of food systems and of their R&I systems. Key Findings and Conclusions Seizing the opportunities to transform R&I systems has implications for how research is done – pointing to the need for competence development among researchers, policy makers and society in general – and requires specific governance interventions that stimulate a systemic approach. Such interventions should foster transdisciplinary and transformative research agendas that stimulate portfolios of projects that will reinforce one another, and stimulate innovative experiments to shape conditions for systemic change. In short, a thorough rethinking of the role of R&I as well as how it is funded is a crucial step towards the development of the integrative policies that are necessary to engender systemic change – in the food system and beyond

A Systems Approach to Research and Innovation for Food System Transformation

This policy brief of the European Union (EU) Think Tank – part of the FIT4FOOD2030 Coordination and Support Action (CSA) of the FOOD 2030 initiative – is a response and contribution to growing pleas for a ‘systems approach’ to transform food systems for Food and Nutrition Security (FNS) for present and future generations. This policy brief specifically focusses on the necessity of the adoption of a systems approach to Research and Innovation (R&I) in order to foster the transformation of food systems

Research and Innovation Supporting the Farm to Fork Strategy of the European Commission

The EU Think Tank (as part of the FIT4FOOD2030 Coordination andSupport Action) strongly supports the development of the Farm toFork Strategy as a key component of the European Green Deal,recognising the need to transform the food system as a whole

Key Research and Innovation Questions on Engaging Consumers in the Delivery of FOOD 2030

Food system transformation requires major changes in food consumption practices. Consumers could play central roles to stimulate these changes, which needs to be fully recognized. Multi-stakeholder R&I efforts should focus more on the interactions between individual, contextual and policy factors influencing consumption patterns, with specific attention to the dynamic character of food environments. Consumers should be empowered and engaged in decision making, through co-design, co-creation, co-implementation and co-assessment

Population size of Oystercatchers Haematopus ostralegus wintering in Iceland

The first ever survey of Oystercatchers wintering in Iceland found around 11 000 individuals. This is an estimated 30% of the Icelandic population, including juveniles, suggesting that approximately 26 000 Icelandic Oystercatchers migrate to western Europe in the autumn. More Oystercatchers winter in Iceland than at similar latitudes elsewhere in Europe, which may reflect the remoteness and milder winter temperatures on this oceanic island

Secondary education reform in Lesotho and Zimbabwe and the needs of rural girls: Pronouncements, policy and practice

Analysis of the educational needs of rural girls in Lesotho and Zimbabwe suggests a number of shortcomings in the current form of secondary education, and ways in which it might be modified so as to serve this sizeable group of students better. Several of the shortcomings, notably in relation to curricular irrelevance and excessive focus on examinations, have long been recognised, including by politicians. Yet political pronouncements are seldom translated into policy, and even where policy is formulated, reforms are seldom implemented in schools. This paper makes use of interviews with educational decision-makers in the two southern African countries and a range of documentary sources to explore why, despite the considerable differences between the two contexts, much needed educational reforms have been implemented in neither