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This paper focuses on business models and value chains to analyse sectoral innovation systems involving synthetic biology and gene editing, as potentially disruptive platform technologies in the life sciences. In the context of industrial biotechnology, we propose that the extent to which an innovation is expected to be disruptive, and the location of that disruption in existing value chains, are relevant to policy decision making on how to govern innovative technologies. Policy decisions on how to regulate or support an innovative technology will be among the most important factors determining the extent to which it is able to deliver its disruptive potential, leading to sectoral transformations through new business models and value chains. This mode of thinking about disruption and innovation could be incorporated in standard procedures for policy makers to guide decisions designed to support translation from basic scientific research to societally useful products and processes. [ABSTRACT FROM AUTHOR]

The paper aims to build understanding of the recent growth of interest in engineering for international development as an emerging focus of new knowledge, practice, and community development. In the paper, we create a borderlands approach to studying the activities referred to as engineering for development and development engineering. These activities take place in 'borderland' spaces where new approaches are being tried out through creative engagement of networks and communities willing to integrate social as well as technical knowledge and practice. We analyze four cases, selected as exemplars of engineering for development, from a large data set of case studies to demonstrate the socio-economic impact of research. We found evidence of important and original engineering, which showed paradigmatic shifts in engineering knowledge and practice. There was ambivalence inside the engineering community about engineering quality, mixing pride in the building of new paradigms with modesty about whether new knowledge and practices were 'real' engineering. These findings provide evidence that engineering aimed at global development offers an exciting new 'borderlands' approach to engineering that warrants further study. [ABSTRACT FROM AUTHOR]

Some emerging countries have made significant progress in developing local pharmaceutical and biotechnology but had less success in building medical device industries (MDIs). This paper explores the weak development of local MDIs by analysing the contrasting evolutionary trajectories of Indian healthcare technology sectors. The Indian pharmaceutical and biotechnological industries have emerged as leading global suppliers of generic drugs and vaccines, in marked contrast to the medical devices industry. This paper reveals that existence of a weak collaborative linkage between medical device manufacturers and the Indian health system, which largely lacks a systemic and cross-sectoral linkages, and weak communication between industry and government policy-makers have become a huge barrier to the development of the Indian MDI in the contemporary neo-liberal environment. The weak connection between technology and industrial policy and healthcare policy objectives has severely hampered both development of national technological capabilities and the creation of affordable health care. [ABSTRACT FROM AUTHOR]

In this paper, we investigate the implementation challenge of Smart Specialisation Strategies (S3) in catch-up regional environments, through the lens of capacity building. We analyse capacity building at two levels: micro-level (individual organisations) and meso-level (regional inter-organisational networks). We use empirical evidence from 50 interviews conducted in the period 2015-2017 from two Greek regions dramatically hit by the economic crisis (Crete and Central Macedonia). We argue that in the Cretan and Central Macedonian context, the difficulty of implementing S3 is directly linked with firms' lack of adsorptive capability to exploit university-generated knowledge, university knowledge that is too abstract for firm's to easily acquire, as well as to the capability of regional actors to build inter-organisational networking that fits their strategic needs. [ABSTRACT FROM AUTHOR]

The importance of science in development has been increasingly recognised in development discourses and policy since 2000. Engineering is less visible though engineering and engineers are important for the building and maintenance of transport, water, energy, industrial, informatics, urban and health systems. This article aims to investigate why engineering has not received more emphasis, including why development engineering has not been institutionalised like tropical medicine. It explores the nature of engineering in development, highlights recent efforts to headline engineering for development and, using analyses of what engineers know and do inside international development, suggests that its profile and effectiveness is emerging. [ABSTRACT FROM AUTHOR]

The decades since the 1950s have witnessed major growth in the bioeconomy. Emergence of the bioeconomy as a broad, creative and rapidly expanding part of the global economy coincides with the maturation of the established drug discovery system. This paper presents research evidence focused on the relationships between changes in the bioeconomy and changes in the global economy. It argues that new forms of governance and regulation are key to strengthen industrial policies needed for emerging and developing countries to take account of the complex interactions in life science innovation between technology, markets, regulation and civil society, which could significantly impact on global distribution of the industry. [ABSTRACT FROM PUBLISHER]

The intellectual property regime forms an important part of any government's economic and industrial policies. It is an important regulatory instrument not only affecting industry and market structure but also influencing firm-level learning strategies, especially in knowledge-based industries like pharmaceuticals. Given its crucial role, the strengthening of patent laws as a result of the Trade Related Intellectual Property Rights (TRIPS) agreement presents a significant institutional change for developing country industry. This paper analyses Indian pharmaceutical firms' strategic response to the strengthening of patent law. The research in this paper shows that Indian pharmaceutical firms responded to anticipated disruptive regulatory change by developing competencies incrementally as well as radically. Ambidextrous capability development involved explorative investment in R&D to develop innovative product R&D competencies and in parallel also involved exploitative use of existing process R&D capabilities. This ambidextrous capability development has enabled Indian pharmaceutical firms to survive and compete with multinational corporation (MNC) pharmaceutical firms, showing other catch-up firms a different path of capability development. [ABSTRACT FROM AUTHOR]

This paper analyses how firms organize for industrial innovation where they are significantly below being globally competitive. It investigates the dynamics by which catch-up firms in developing countries (DCs) go beyond the boundaries assigned to them by their national environments and by the world's leading technology-driven firms. The paper analyses cases of how a range of successful firms managed to break these boundaries to increase competitiveness through innovation. Our key argument concerns the innovation dynamics of catch-up firms. We argue that aspirant firms approach the frontier differently to leaders. We construct and use a tool, based on resource-based theory, to map the alternative approaches taken by firms to develop new capabilities. It focuses on the relationship between process and product innovation and the nature of proprietary competencies. This allows the development of approaches to build strategies for innovation in DC catch-up firms and thereby transform development dynamics. [ABSTRACT FROM AUTHOR]

Some industrially advanced developing countries have, in the last decades, built substantial pharmaceutical scientific and industrial capabilities. The more advanced of these countries have built chemical and biological R&D, generic and reverse engineering, and drug discovery capabilities. There have been tremendous barriers to entry but nevertheless a range of imitative approaches have evolved, with some significant scientific, health and industrial advances. Opportunities in India are in part created by the problems of maturity being faced by big pharmaceutical firms in developed countries. Big pharmaceutical firms are searching for novel approaches to retain a high value-added model of innovation for drug development. These difficulties provide opportunities for innovative companies in developing countries. This paper explores the challenges faced under these circumstances by Indian pharmaceutical companies. Are they attempting to 'catch-up' by chasing a failing model of innovation? Do they have an alternative model? Or can they become an important part of a transformed new global model of pharmaceutical innovation? [ABSTRACT FROM AUTHOR]

This paper addresses the question of how Indian pharmaceutical firms have transformed themselves from reverse-engineering firms focused on the domestic market to research-driven firms with global presence. It analyses the crucial and changing role of national, then international, innovation and regulatory policies and their impact on growth, performance and technology evolution of Indian pharmaceutical firms. The paper argues that although public policy increased market turbulence, it also provided new opportunities for firms to expand and build new technology, knowledge and market capabilities. From the 1950s Indian firms have pursued a variety of research, marketing and internationalization strategies to tackle changes prompted by policy, markets and knowledge complexities. The paper traces firm strategies that vary both in time and by firm, and argues that the successful firms have evolved substantively towards knowledge-based strategies. The paper then attempts to identify future directions for strategy, knowledge and markets. [ABSTRACT FROM AUTHOR]

The authors reflect on the development of pharmaceutical industry before and after the implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in India. They cite that between 1950s to 1960s the industry has a weak growth due to multinational company subsidiaries while in 1970s it has massive changes because of the government policy. The TRIPS legislation has driven transformations in the industry that lead to global competitiveness.

Multinational companies in the life science sector are heavily influenced by government policies and regulations and in turn attempt to influence these actors nationally and internationally. This paper focuses on recent and on-going research, principally on the agro-biotechnology and, to a lesser extent, on the pharmaceutical industries, covering the evolution of policy and regulation in Europe, how policies are influenced by stakeholder pressures and how policy in turn influences company strategies for product development. We focus particularly on new ‘governance’ agendas in Europe and consider the relative impacts of enabling, constraining, discriminating and indiscriminate policies on company strategies as part of our development of an integrated approach to policy and governance. We also consider changes in external operating environments for multinational companies and compare past histories and present pressures on agro-biotechnology and pharmaceutical companies. The paper argues, with evidence, that a more enabling and discriminating policy and regulatory environment can achieve public goals more efficiently and effectively, taking account of impacts on innovation, than more blunt policy instruments. This type of environment takes into account the resources and capabilities available to firms and research laboratories rather than relying on broad brush carrot and stick approaches. [ABSTRACT FROM AUTHOR]

The first genetically modified crops and foods to be approved for commercial use in the European Union have prompted intense controversy. Food retailers and processors have been forced to take up the concerns voiced by their customers. New networks of groups have formed to oppose the technology. In response to these pressures, regulators who approved the products have had to reconsider questions they had previously dismissed or officially resolved. Governments have devised more precautionary measures of various kinds. For example, they have increased the burden of evidence for demonstrating safety, have broadened the practical definition of the ‘adverse effects’ which must be prevented, and have devised marketstage precautions for such effects. These extra measures manage the risk debate as well as any risks. In such ways, the technocratic model of European harmonization is being challenged and superseded. This may allow differences in national practices to be viewed as valuable expert resources for a different harmonization model, rather than as deviations from a universal rational norm. Regulatory conflicts offer precautionary opportunities, which could lead to more flexible and democratic procedures. Theoretical perspectives – on risk, uncertainty, precaution, European integration, expertise and the internal market – help illuminate these possibilities. [ABSTRACT FROM AUTHOR]

This paper focuses on the contradictory relationship between tools, always open to criticism as technocratic and mechanistic, and processes of development. It focuses on the tools often known as Logical Framework Approach (LFA) which are increasingly used as process tools by many different agencies, including those who espouse values of participation and empowerment. We assess the tools from the perspective of their use in public action-based approaches, as a means to improve clarity and focus in multi-actor interventions. No one tool can fulfil the range of tasks required in complex situations and LFA is useful as one of various options. We consider two of its limitations. First, it can be used in many different styles, including as a means to analyse public interest as contested terrain, or as a technocratic tool. Second, the focus on viewing assumptions as immutable can limit the effectiveness of interventions. [ABSTRACT FROM AUTHOR]

Public controversy has intensifed over the environmental effects of genetically modified organisms (GMOs) amid contending accounts of sustainable agriculture. In regulating these products, the UK has extended its 'consultative' style, seeking to maintain the appearance of expert neutrality. To anticipate and incorporate potential dissent, the government adopted precautionary legislation and established a broadly-based advisory committee. Although the UK regulation is officially 'risk-based', in practice it involves a qualitative assessment of the acceptability and plausibility of potential effects. In this way, the risk debate has become scientized: some uncertainties are translated into technical criteria, while others are downplayed or deferred. These official judgements have been seriously challenged, especially at the commercial stage of herbicide-tolerant crops. Pressure groups hold regulators publicly accountable for controlling risks which the government had excluded from GMO regulation. In all those ways, the UK consultative style has come under strain. The regulatory procedure faces dilemmas- between setting narrow regulatory boundaries versus gaining legitimacy for products; between enabling commercial use versus extending precautionary controls; and between providing some public access versus limiting participation. These strains are illuminated here by two theoretical perspectives- 'reflexive scientization' and 'national regulatory styles'. [ABSTRACT FROM AUTHOR]

Examines the importance of regulation for social control of technology. Effects of regulatory policies on the development of technology; Controversy over the control of technology; Components of technology policy.

Examines the problems associated with work on environment product development projects experienced by engineers in Great Britain. Legislation for environmental protection; Development of innovative products and processes generated by environmental concerns; Problems affecting innovative product development in business organizations.

Examines the material composition of generic technology of revolutionary significance. Changes in materials science and technology; Corporate and public policy on material innovation; Factors attributing to the impact of material technology on industrial operation.