Assessing switchability for biosimilar products: modelling approaches applied to children's growth

The present paper describes two statistical modelling approaches that have been developed to demonstrate switchability from the original recombinant human growth hormone (rhGH) formulation (Genotropin^®) to a biosimilar product (Omnitrope^®) in children suffering from growth hormone deficiency. Demonstrating switchability between rhGH products is challenging because the process of growth varies with the age of the child and across children. The first modelling approach aims at predicting individual height measured at several time‐points after switching to the biosimilar. The second modelling approach provides an estimate of the deviation from the overall growth rate after switching to the biosimilar, which can be regarded as an estimate of switchability. The results after applying these approaches to data from a randomized clinical trial are presented. The accuracy and precision of the predictions made using the first approach and the small deviation from switchability estimated with the second approach provide sufficient evidence to conclude that switching from Genotropin^® to Omnitrope^® has a very small effect on growth, which is neither statistically significant nor clinically relevant. Copyright © 2015 John Wiley & Sons, Ltd.     

Hidden Agendas in Beratungs-und Veränderungsprozessen

Consulting and organization development claim to boost the client organization’s efficiency — this official goal is frequently foiled by hidden agendas which are not officially communicated. Hidden functions of consulting are to prove to the management’s legitimacy, to explain the failure of change processes, to strengthen the initator’s position in internal power struggles or to relieve the system from conflict. On the consultants’ side there is a tension between professionalism on one side and the necessity to secure follow-up projects and to sell standard products on the other side. The authors present possible interpretations for such hidden agendas and illustrate them with case studies from their practical experience as consultants.     

Missing in Action: Strategic Human Resource Management in German Nonprofits

Human resource (HR) management is important for human service nonprofits because they rely on the quality of their employees for the provision of their services. Using a typology of nonprofit HR architecture developed by Ridder and McCandless (Nonprofit Volunt Sect Q 29(1):124–141, 2010), we attempt to unpack the black box between performance and HR practices. To this end, we conducted semi-structured interviews with HR managers and young employees to investigate their perceptions of HR practices in their nonprofit organizations. Based on the findings, we extend the research on HR management in nonprofit organizations and caution that success or failure of implementing HR practices may be directly influenced by the external environment.     

Schade,es war mal wieder keine Zeit zur Diskussion. Persönliche Eindrücke vom Kongress

Ohne Zusammenfassung     

Black Caribbean Empowerment and Early Eighteenth-Century Moravian Missions Documents

The article suggests a new reading of the documents related to the early period of eighteenth-century Moravians' missionary activities in the Danish West Indies that started in 1732. The early period of Moravian missionary presence – between the 1730s and 1760s – differed from subsequent periods because later periods lost the original attempts to establish spiritual equality. A close reading of the various documents allows one to detect forms of active protest and creative agency on the part of enslaved people that were fostered, wittingly or unwittingly, by the Moravian missionaries. The article claims that the early Moravian missionaries to the Danish West Indies laid a spiritual foundation that provided a great deal more encouragement and secular empowerment to the thousands of slaves with whom they came into contact than has been considered so far in the scholarship.