No abstract

No abstract

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision‐making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.

We pursue what it means to be an 'open innovator' and what conditions this choice. Using the UK Innovation Survey Database 2005, we test different measures of 'openness' across a large data set and find that open innovation practices vary across firms and sectors, giving support to the view that openness is not strictly a choice for the firm but an outcome of capabilities, industrial organisation and wider innovation systems. Within the firm, design is revealed as a core capability that shapes open innovation practice, reflecting its role in innovation task partitioning. We confirm this in our robust findings that design is accorded higher importance by firms which have open innovation practices.

No abstract

Increasingly the firm meets limits to its reach over the breadth of technologies and capabilities that are needed to innovate. Empirical study has shown that innovation processes are distributed across a variety of actors. The distribution of innovation processes across actors calls for specific forms of governance which extend across the boundaries of the firm, such as loosely coupled innovative networks. Technological and market drivers determine the location of agents within such networks, reflecting their needs and capabilities to co-ordinate systemic knowledge and power dependencies. The paper discusses the theoretical perspectives on the technological and market dimensions involved in the co-ordination of distributed innovative activities, proposing an interpretative framework for the investigation of R&D collaborations. Exploring these topics through the lens of the upstream petroleum industry, we investigate the relationship between competitive domains, technological profiles and positioning of actors within R&D networks, arguing that technological and market power contribute differently to the evolution of co-ordinating (nexus) functions over time.Collaborative R&D, Distributed innovation processes, R&D networks, Oil and gas,

We consider here the governance of learning and the diffusion of technological knowledge in the civil aircraft industry. We describe a systemic process by which specialization in knowledge encourages depth whilst breadth is captured through the integration of contributions by the lead manufacturer, which acts as systems integrator. We explore the boundaries of the knowledge bases related to airframe structure and systems and aircraft instrumentation by using patents as tracers, considering the range of scientific and technological disciplines related to the industry as well as the sources of that knowledge. We conclude that knowledge base supporting the aeronautics industry is complex and multidisciplinary, and that firms acting as system integrators have to hold the broadest knowledge bases to co-ordinate design and production.

Background Current knowledge is limited about which manufacturers are active in the global field of biopharmaceutical product development and how many unique follow-on biologics are approved in global markets. Objective This study aimed to provide a cross-sectional overview of manufacturers of follow-on biologics approved in 15 large countries from different regions of the world, as well as in five major biosimilar markets with long established biosimilar frameworks. Methods We screened national drug databases to identify follow-on biologics and their manufacturers approved in 15 countries in Asia, Africa, Latin America and the rest of the world, as well as five major biosimilar markets: the European Union (including the UK), USA, Canada, Australia and Japan. Results This study identified a total of 304 follow-on biologics from different manufacturers for 18 active substance classes included in the analysis. Of these, 67 products are approved as biosimilars in at least one of the five major biosimilar markets. A total of 140 (46%) follow-on biologics are manufactured in India or China, of which only eight (seven from India and one from China) are approved as biosimilars in any of the five major biosimilar markets. This study found that the majority of follow-on biologics are only approved in the respective country of manufacturing. A small number of manufacturers, primarily from India and Argentina, supply their products to other regions in the world. As some countries have less stringent regulatory approaches for biosimilars, or have only recently implemented biosimilar guidance in line with World Health Organization standards, follow-on biologics could have been approved that would not be considered biosimilars according to the World Health Organization standards. Conclusions With this study, we try to contribute to discussions on creating more transparency about global approvals of follow-on biologics and promoting access to high-quality biosimilars in countries around the world.