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Background:
Anti-TNFα monoclonal antibodies (mAbs) are a well-established treatment for patients with Crohn’s disease (CD). However, subtherapeutic concentrations of mAbs have been related to a loss of response during the first year of therapy1. Therefore, an appropriate dosing strategy is crucial to prevent the underexposure of mAbs for those patients. The aim of our study was to assess the impact of different dosing strategies (fixed dose or body size descriptor adapted) on drug exposure and the target concentration attainment for two different anti-TNFα mAbs: infliximab (IFX, body weight (BW)-based dosing) and certolizumab pegol (CZP, fixed dosing). For this purpose, a comprehensive pharmacokinetic (PK) simulation study was performed.
Methods:
A virtual population of 1000 clinically representative CD patients was generated based on the distribution of CD patient characteristics from an in-house clinical database (n = 116). Seven dosing regimens were investigated: fixed dose and per BW, lean BW (LBW), body surface area, height, body mass index and fat-free mass. The individual body size-adjusted doses were calculated from patient generated body size descriptor values. Then, using published PK models for IFX and CZP in CD patients2,3, for each patient, 1000 concentration–time profiles were simulated to consider the typical profile of a specific patient as well as the range of possible individual profiles due to unexplained PK variability across patients. For each dosing strategy, the variability in maximum and minimum mAb concentrations (Cmax and Cmin, respectively), area under the concentration-time curve (AUC) and the per cent of patients reaching target concentration were assessed during maintenance therapy.
Results:
For IFX and CZP, Cmin showed the highest variability between patients (CV ≈110% and CV ≈80%, respectively) with a similar extent across all dosing strategies. For IFX, the per cent of patients reaching the target (Cmin = 5 µg/ml) was similar across all dosing strategies (~15%). For CZP, the per cent of patients reaching the target average concentration of 17 µg/ml ranged substantially (52–71%), being the highest for LBW-adjusted dosing.
Conclusion:
By using a PK simulation approach, different dosing regimen of IFX and CZP revealed the highest variability for Cmin, the most commonly used PK parameter guiding treatment decisions, independent upon dosing regimen. Our results demonstrate similar target attainment with fixed dosing of IFX compared with currently recommended BW-based dosing. For CZP, the current fixed dosing strategy leads to comparable percentage of patients reaching target as the best performing body size-adjusted dosing (66% vs. 71%, respectively).
From learners to educators
(2020)
The rapid growth of technology and its evolving potential to support the transformation of teaching and learning in post-secondary institutions is a major challenge to the basic understanding of both the university and the communities it serves. In higher education, the standard forms of learning and teaching are increasingly being challenged and a more comprehensive process of differentiation is taking place. Student-centered teaching methods are becoming increasingly important in course design and the role of the lecturer is changing from the knowledge mediator to moderator and learning companion. However, this is accelerating the need for strategically planned faculty support and a reassessment of the role of teaching and learning. Even though the benefits of experience-based learning approaches for the development of life skills are well known, most knowledge transfer is still realized through lectures in higher education. Teachers have the goal to design the curriculum, new assignments, and share insights into evolving pedagogy. Student engagement could be the most important factor in the learning success of university students, regardless of the university program or teaching format. Against this background, this article presents the development, application, and initial findings of an innovative learning concept. In this concept, students are allowed to deal with a scientific topic, but instead of a presentation and a written elaboration, their examination consists of developing an online course in terms of content, didactics, and concept to implement it in a learning environment, which is state of the art. The online courses include both self-created teaching material and interactive tasks. The courses are created to be available to other students as learning material after a review process and are thus incorporated into the curriculum.
While Information Systems (IS) Research on the individual and workgroup level of analysis is omnipresent, research on the enterprise-level IS is less frequent. Even though research on Enterprise Systems and their management is established in academic associations and conference programs, enterprise-level phenomena are underrepresented. This minitrack provides a forum to integrate existing research streams that traditionally needed to be attached to other topics (such as IS management or IS governance). The minitrack received broad attention. The three selected papers address different facets of the future role of enterprise-wide IS including aspects such as carbonization, ecosystem integration, and technology-organization fit.
While Information Systems Research exists at the individual and workgroup levels, research on IS at the enterprise level is less common. The potential synergies between the study of enterprise systems (ES) and related fields have been underexplored and often treated as separate entities. The ongoing challenge is to seamlessly integrate technological advances and align business processes across organizations. While systems integration within an organization is common, changes occur when industry and ecosystem perspectives come into play. The four selected papers address different facets of the future role of enterprise ecosystems, including implementation challenges, ecosystem boundaries, and B2B platform specifics.
Enterprise solutions, specifically enterprise systems, have allowed companies to integrate enterprises’ operations throughout. The integration scope of enterprise solutions has increasingly widened, now often covering customer activities, activities along supply chains, and platform ecosystems. IS research has contributed a wide range of explanatory and design knowledge dealing with this class of IS. During the last two decades, many technological as well as managerial/organizational innovations extended the affordances of enterprise solutions—but this broader scope also challenges traditional approaches to their analysis and design. This position paper presents an enterprise-level (i.e., cross-solution) perspective on IS, discusses the challenges of complexity and coordination for IS design and management, presents selected enterprise-level insights for IS coordination and governance, and explores avenues towards a more comprehensive body of knowledge on this important level of analysis.
Scaling up CSP
(2023)
Concentrating solar power (CSP) is one of the few scalable technologies capable of delivering dispatchable renewable power. Therefore, many expect it to shoulder a significant share of system balancing in a renewable electricity future powered by cheap, intermittent PV and wind power: the IEA, for example, projects 73 GW CSP by 2030 and several hundred GW by 2050 in its Net-Zero by 2050 pathway. In this paper, we assess how fast CSP can be expected to scale up and how long time it would take to get new, high-efficiency CSP technologies to market, based on observed trends and historical patterns. We find that to meaningfully contribute to net-zero pathways the CSP sector needs to reach and exceed the maximum historical annual growth rate of 30%/year last seen between 2010-2014 and maintain it for at least two decades. Any CSP deployment in the 2020s will rely mostly on mature existing technologies, namely parabolic trough and molten-salt towers, but likely with adapted business models such as hybrid CSP-PV stations, combining the advantages of higher-cost dispatchable and low-cost intermittent power. New third-generation CSP designs are unlikely to play a role in markets during the 2020s, as they are still at or before the pilot stage and, judging from past pilot-to-market cycles for CSP, they will likely not be ready for market deployment before 2030. CSP can contribute to low-cost zero-emission energy systems by 2050, but to make that happen, at the scale foreseen in current energy models, ambitious technology-specific policy support is necessary, as soon as possible and in several countries.