James Mittra | University of Edinburgh (original) (raw)

Papers by James Mittra

We also thank all those involved in scientific research, product development and product regulati... more We also thank all those involved in scientific research, product development and product regulation who willingly gave their time to enable us to develop the case studies for this analysis.

Investment in biotechnology has yielded relatively disappointing results and illustrates the gap ... more Investment in biotechnology has yielded relatively disappointing results and illustrates the gap between the promise and reality of new science. This begs the question: Does research on 'life' bring different complexities and uncertainties that act as a barrier to the application of new biology in global health and agriculture? There has been high-quality research on the social and ethical impacts of new biology and on the economics of biotechnology but few systematic and integrated attempts to undertake interdisciplinary research and address these constraints. This paper provides an original empirical analysis of contemporary and future understandings of the bioeconomy using a co-evolutionary and interactive approach to examine the extent to which it may be different from other technological transformations. We focus on the Innogen Centre's extensive research results on three important and contemporary themes: food and energy security, life science and healthcare translational medicine, and global health.

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pi... more The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system.

Stratified medicine offers both opportunities and challenges to the conventional business models ... more Stratified medicine offers both opportunities and challenges to the conventional business models that drive pharmaceutical R&D. Given the increasingly unsustainable blockbuster model of drug development, due in part to maturing product pipelines, alongside increasing demands from regulators, healthcare providers and patients for higher standards of safety, efficacy and cost-effectiveness of new therapies, stratified medicine promises a range of benefits to pharmaceutical and diagnostic firms as well as healthcare providers and patients. However, the transition from 'blockbusters' to what might now be termed 'niche-busters' will require the adoption of new, innovative business models, the identification of different and perhaps novel types of value along the R&D pathway, and a smarter approach to regulation to facilitate innovation in this area. In this paper we apply the Innogen Centre's interdisciplinary ALSIS methodology, which we have developed for the analysis of life science innovation systems in contexts where the value creation process is lengthy, expensive and highly uncertain, to this emerging field of stratified medicine. In doing so, we consider the complex collaboration, timing, coordination and regulatory interactions that shape business models, value chains and value systems relevant to stratified medicine. More specifically, we explore in some depth two convergence models for co-development of a therapy and diagnostic before market authorisation, highlighting the regulatory requirements and policy initiatives within the broader value system environment that have a key role in determining the probable success and sustainability of these models.

In light of a recent House of Commons Select Committee investigation into the regulation of human... more In light of a recent House of Commons Select Committee investigation into the regulation of human reproductive technologies, this article critically evaluates the Committee's case for a devolved, libertarian-inspired framework for the regulation of reproductive technologies. In assessing the appropriate balance between legislation, regulation and reproductive freedom, the Committee rightly challenged those who exhibit a myopic history of eugenics to justify restricting reproductive choice. However, by uncritically embracing the tropes of procreative liberty and genetic progress, and defining eugenics in terms of intention rather than consequence, the Committee appeared to ignore or marginalise a number of sociological challenges to the presumptions couched within the doctrine of 'liberal choice'. This article suggests that failure to consider the cultural and political context within which new technologies are shaped and social needs constructed might undermine any ostensible virtues of a devolved system of governance for reproductive medicine.

This article critically analyses the events leading up to the 2004 merger between the pharmaceuti... more This article critically analyses the events leading up to the 2004 merger between the pharmaceutical companies Sanofi-Synthelabo and Aventis. It reveals the social, commercial and political complexities and challenges of a merger process in which the defence of French national interests and regional capabilities competed with traditional 'commercial' narratives before the deal was closed. The merger is analysed within the broader context of contemporary debates, within the strategic management and innovation systems literature, about the process of global innovation in pharmaceuticals, industry consolidation and the discursive socio-political discourses that underlie cross-border merger and acquisition activity. The article critically evaluates the competing criteria adopted by government and industry to justify different merger scenarios and considers the implications for pharmaceutical innovation, industry consolidation and M&A theory.

The life sciences are having a significant impact on the organisation and management of R&D in la... more The life sciences are having a significant impact on the organisation and management of R&D in large pharmaceutical firms, as well as restructuring the markets for new therapeutic products. However, there is continuing scepticism about large firms' ability or inclination to build in-house capacity for biologics and extract value from the life sciences. This paper explores the effect of life science innovation on early and late-stage R&D, and considers the implications for strategic management and the transition of compounds through the middle stages of the R&D pathway. The analysis, which includes two company case studies, reveals that new life science technologies have had a marginal impact on late-stage R&D, but companies are exploring new organisational or translational models to better exploit the science and reduce the phase 2 attrition rates. Findings suggest that firms have the capability to adapt to a new innovation trajectory, but external pressures on strategic and organisational management will continue to determine the level and rate of success.

We also thank all those involved in scientific research, product development and product regulati... more We also thank all those involved in scientific research, product development and product regulation who willingly gave their time to enable us to develop the case studies for this analysis.

Investment in biotechnology has yielded relatively disappointing results and illustrates the gap ... more Investment in biotechnology has yielded relatively disappointing results and illustrates the gap between the promise and reality of new science. This begs the question: Does research on 'life' bring different complexities and uncertainties that act as a barrier to the application of new biology in global health and agriculture? There has been high-quality research on the social and ethical impacts of new biology and on the economics of biotechnology but few systematic and integrated attempts to undertake interdisciplinary research and address these constraints. This paper provides an original empirical analysis of contemporary and future understandings of the bioeconomy using a co-evolutionary and interactive approach to examine the extent to which it may be different from other technological transformations. We focus on the Innogen Centre's extensive research results on three important and contemporary themes: food and energy security, life science and healthcare translational medicine, and global health.

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pi... more The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system.

Stratified medicine offers both opportunities and challenges to the conventional business models ... more Stratified medicine offers both opportunities and challenges to the conventional business models that drive pharmaceutical R&D. Given the increasingly unsustainable blockbuster model of drug development, due in part to maturing product pipelines, alongside increasing demands from regulators, healthcare providers and patients for higher standards of safety, efficacy and cost-effectiveness of new therapies, stratified medicine promises a range of benefits to pharmaceutical and diagnostic firms as well as healthcare providers and patients. However, the transition from 'blockbusters' to what might now be termed 'niche-busters' will require the adoption of new, innovative business models, the identification of different and perhaps novel types of value along the R&D pathway, and a smarter approach to regulation to facilitate innovation in this area. In this paper we apply the Innogen Centre's interdisciplinary ALSIS methodology, which we have developed for the analysis of life science innovation systems in contexts where the value creation process is lengthy, expensive and highly uncertain, to this emerging field of stratified medicine. In doing so, we consider the complex collaboration, timing, coordination and regulatory interactions that shape business models, value chains and value systems relevant to stratified medicine. More specifically, we explore in some depth two convergence models for co-development of a therapy and diagnostic before market authorisation, highlighting the regulatory requirements and policy initiatives within the broader value system environment that have a key role in determining the probable success and sustainability of these models.

In light of a recent House of Commons Select Committee investigation into the regulation of human... more In light of a recent House of Commons Select Committee investigation into the regulation of human reproductive technologies, this article critically evaluates the Committee's case for a devolved, libertarian-inspired framework for the regulation of reproductive technologies. In assessing the appropriate balance between legislation, regulation and reproductive freedom, the Committee rightly challenged those who exhibit a myopic history of eugenics to justify restricting reproductive choice. However, by uncritically embracing the tropes of procreative liberty and genetic progress, and defining eugenics in terms of intention rather than consequence, the Committee appeared to ignore or marginalise a number of sociological challenges to the presumptions couched within the doctrine of 'liberal choice'. This article suggests that failure to consider the cultural and political context within which new technologies are shaped and social needs constructed might undermine any ostensible virtues of a devolved system of governance for reproductive medicine.

This article critically analyses the events leading up to the 2004 merger between the pharmaceuti... more This article critically analyses the events leading up to the 2004 merger between the pharmaceutical companies Sanofi-Synthelabo and Aventis. It reveals the social, commercial and political complexities and challenges of a merger process in which the defence of French national interests and regional capabilities competed with traditional 'commercial' narratives before the deal was closed. The merger is analysed within the broader context of contemporary debates, within the strategic management and innovation systems literature, about the process of global innovation in pharmaceuticals, industry consolidation and the discursive socio-political discourses that underlie cross-border merger and acquisition activity. The article critically evaluates the competing criteria adopted by government and industry to justify different merger scenarios and considers the implications for pharmaceutical innovation, industry consolidation and M&A theory.

The life sciences are having a significant impact on the organisation and management of R&D in la... more The life sciences are having a significant impact on the organisation and management of R&D in large pharmaceutical firms, as well as restructuring the markets for new therapeutic products. However, there is continuing scepticism about large firms' ability or inclination to build in-house capacity for biologics and extract value from the life sciences. This paper explores the effect of life science innovation on early and late-stage R&D, and considers the implications for strategic management and the transition of compounds through the middle stages of the R&D pathway. The analysis, which includes two company case studies, reveals that new life science technologies have had a marginal impact on late-stage R&D, but companies are exploring new organisational or translational models to better exploit the science and reduce the phase 2 attrition rates. Findings suggest that firms have the capability to adapt to a new innovation trajectory, but external pressures on strategic and organisational management will continue to determine the level and rate of success.