Conducting Drug Treatment Trials in Children: Opportunities and Challenges.

The high level of regulation of innovative drugs on the market, which is necessary to protect consumers, produces important effects on drug availability and innovation. In public healthcare systems, the need to curb prices comes from expenditure considerations. The aim of price regulation is to obtain a more equitable allocation of the value of an innovative drug between industries and patients (by reducing prices to make drugs more affordable), but it may also reduce access. (In the listing process, the industry may find it more convenient to limit commercialisation to profitable subgroups of patients.) Furthermore, with the advent of personalised medicine, there is another important dimension that has to be considered, namely, incentives to invest in drug personalisation. In this paper, we review and discuss the impact of different pricing rules on the expenditure and availability of new drugs.

Timely, Cheap, or Risk-Free? The Effect of Regulation on the Price and Availability of New Drugs.

Digital transformation (DT) is a critical area of focus as it disruptively transforms organizational business models, processes, and products. Despite being a prominent topic among information system scholars, the research has mostly centered around technological aspects, and there is a need to broaden the research approach to increase the understanding of DT's intricate dynamics, interdisciplinary nature, and cross-level perspectives, with practical guidance, while providing actionable insights for organizations. Through action design research, we elaborate a practical Digital-by-Design (DbD) framework grounded in theoretical foundations, to emphasize the interconnected dimensions of people, process and technology for enhancing DT feasibility and viability. This research contributes to a deeper understanding of DT initiatives by recognizing the significance of: 1) diverse organizational, process, and industry needs; 2) individual uniqueness concerning DT; 3) technology integration and scale-up patterns; 4) cross-level empirical perspectives; and 5) an interdisciplinary approach by supporting organizations when navigating DT complexities and dynamics. Recognizing the practical managerial challenges, the study offers a comprehensive guidance for designing and implementing a DT into the business processes.

Triad of Digital Transformation: Holistic Orchestration for People, Process, and Technology

Role of innovation in pharmaceutical regulation: a proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.

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Role of innovation in pharmaceutical regulation: a proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.