James Mittra

Life Science Innovation and the Restructuring of the Pharmaceutical Industry: Merger, Acquisition and Strategic Alliance Behaviour of Large Firms

Abstract This article explores the transformative nature of the life sciences in the context of pharmaceutical mergers, acquisitions and strategic alliances. Drawing on interviews with senior scientists and managers from large pharmaceutical firms, and secondary data on general industry trends, it identifies diverse company strategies for capturing and exploiting new technologies/knowledge and explores their implications for innovation. The article suggests that mergers, acquisitions and strategic alliances represent a cluster of related activities that provide various strategic options for managing innovation and productivity deficit. However, because the preferred balance between in-house R&D and externally sourced knowledge depends on a number of firm-specific factors, as well as challenges posed by the external operating environment, there is increasing variation between large companies in how these activities are exploited and strategically managed.

Identifying viable regulatory and innovation pathways for regenerative medicine: a case study of cultured red blood cells.

The creation of red blood cells for the blood transfusion markets represents a highly innovative application of regenerative medicine with a medium term (5-10 year) prospect for first clinical studies. This article describes a case study analysis of a project to derive red blood cells from human embryonic stem cells, including the systemic challenges arising from (i) the selection of appropriate and viable regulatory protocols and (ii) technological constraints related to stem cell manufacture and scale up to clinical Good Manufacturing Practice (GMP) standard. The method used for case study analysis (Analysis of Life Science Innovation Systems (ALSIS)) is also innovative, demonstrating a new approach to social and natural science collaboration to foresight product development pathways. Issues arising along the development pathway include cell manufacture and scale-up challenges, affected by regulatory demands emerging from the innovation ecosystem (preclinical testing and clinical trials). Our discussion reflects on the efforts being made by regulators to adapt the current pharmaceuticals-based regulatory model to an allogeneic regenerative medicine product and the broader lessons from this case study for successful innovation and translation of regenerative medicine therapies, including the role of methodological and regulatory innovation in future development in the field.

From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries

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.

Predictive Genetic Information and Access to Life Assurance: The Poverty of ‘Genetic Exceptionalism’

Concern that advances in predictive genetic testing might result in increased numbers of individuals being denied access to life assurance has led many countries to restrict insurers’ historic ‘right to underwrite’. Critics of the insurance industry present genetic discrimination as a threat to the social values of equality and inclusion. However, by unpacking the foundational principles of private insurance, and adopting a more critical approach to genetic information, discrimination, fairness and inclusion, this article suggests that the normative values underpinning life assurance in Britain are unlikely to engender widespread exclusion in an age of increased genetic knowledge, but over-regulation of industry might itself create unacceptable inequity within the market. This suggests that we ought to link the legitimacy of regulatory constraint to the type of social good particular forms of insurance exemplify, and instead of focusing narrowly on genetic information consider the broader implications of risk assessment for the privatization of welfare.

The Socio-Political Economy of Pharmaceutical Mergers: A Case Study of Sanofi and Aventis

Abstract 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.

Evolution of the life science industries

The life sciences have had a transformative impact on a range of innovation-driven industries. The pharmaceutical sector, in particular, has undergone significant organisational change as promissory life science-based technologies and approaches to R&D have begun to challenge the sustainability of small-molecule, blockbuster drug development and the conventional strategic management processes associated with it. The complexity of the biomedical paradigm, and the significant but diverse implications biotechnology and genomics have for various parts of the research and development pathway, has created what appears to be highly distributed innovation systems and networks1 that involve an increasingly diverse range of firms, public sector organisations and technological regimes. Large, traditional pharmaceutical companies are now increasingly reliant on the knowledge, products and expertise of external innovators, such as small dedicated biotechnology firms, as their traditional capabilities in small-molecule drug development no longer appears sufficient to sustain profitable growth. Similarly, the growth of the small-firm sector has engendered new opportunities and challenges for both global therapeutic innovation and regional economic development. National governments have been captured by the promise of biotechnology and sought to cultivate regional biotechnology industries to spur innovation and economic growth. However, the emergence of new technologies and therapeutic options has also posed significant challenges for regulators. New and evolving regulatory standards and protocols, which continue to be developed in a context of much uncertainty, have both directly and indirectly shaped industry’s innovation processes and development strategies, and also affected the relationships and interactions between different types of firm within the sector. Large and small pharmaceutical companies, with both traditional chemical-based strategies and those based on new biotechnology, are therefore facing increasingly turbulent operating environments2 as overall competitiveness in the sector increases; the basic science and emerging technologies become ever more complex, and regulators and downstream stakeholders place greater demands on industry to ensure new therapies are safe, efficacious and cost-effective.

The ‘Entrepreneurial State’ and the leveraging of life in the field of regenerative medicine

Governments are attempting to create a ‘health and wealth’-generating Regenerative Medicine industry in a manner that aligns with the Entrepreneurial State by supporting innovation -facilitating initiatives. This chapter explores such initiatives in the UK and the values invoked within them. The chapter argues that the power of the Entrepreneurial State in reconfiguring the bioeconomy derives from its capacity to appeal to diverse values, and consequently, mobilize and orientate a range of actors (industry , scientists, clinicians and patients ) into a common project aimed at generating ‘health and wealth’. The chapter reflects on the State’s role in attempting to serve as a broker between public and private good, and in doing so it also highlight some of the tensions and countervailing processes at play within the new health bioeconomy .

Prospects for Harmonizing Regulatory Science Programs in Europe, Japan, and the United States to Advance Regenerative Medicine

Background: Regenerative medicine (RM) is a game-changing technology with the potential to repair damaged tissues and organs, but its introduction into the clinic is complicated by the fact that Europe, Japan, and the United States are struggling to make appropriate regulatory decisions about advanced technologies that are highly promising but also uncertain and potentially risky. They have adopted the new approach of regulatory science (RS), applying science-based approaches and standards to support regulatory decision making, to address the challenge. Methods: Is RS the right approach for harmonizing the regulatory mechanisms needed to integrate RM into the mainstream of the development continuum for medical products? If so, what are the prospects for harmonization? We examine the current state of the art for RM and RS in the 3 major drug development regions to answer these questions. Results: Among the practical obstacles to harmonization is the fact that the 3 regions represent different legal jurisdictions and health care systems, with disparate regulatory and reimbursement requirements. However, the regulatory regimes are not without commonalities. Thus, it is not the practical differences that should be debated but rather how best to enhance collaboration. Conclusions: Just as consistent and predictable regulatory support founded on common principles in regulatory science provide the confidence and certainty required to bolster investment in regenerative medicine, harmonization is essential to building that framework on a global scale.

Marginalising ‘eugenic anxiety’ through a rhetoric of ‘liberal choice’: a critique of the House of Commons Select Committee Report on reproductive technologies

In light of a recent House of Commons Select Committee investigation into the regulation of human reproductive technologies, this article critically evaluates the Committees 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.

Evolution of Business Models in Regenerative Medicine: Effects of a Disruptive Innovation on the Innovation Ecosystem

PURPOSE This article focuses on 10 case studies of companies/organizations that are part of the current innovation ecosystem of regenerative medicine (RM) in the United Kingdom. It analyzes the actors, linkages, and influences that will determine the future shape of the RM industry sector and its capacity to live up to its initial expectations. METHODS Using the case study approach, purposive sampling was used to get 18 interview respondents from 10 RM companies/organizations in the United Kingdom. We used semistructured interviews for data gathering and thematic analysis for identifying gaps in the RM value chain (ie, the range of activities required for bringing a product from conception to market and end-use) and the influences of the innovation ecosystem on the evolving RM business models. FINDINGS RM promises to address currently unmet health care needs by restoring the normal form and function of cells, tissues, and organs. The innovations emerging to support the progress of RM to satisfy these important health care markets will disrupt the business models of incumbent industry sectors, particularly pharmaceuticals. Companies involved in this area must develop innovative business models and value chains and negotiate the complex influences of the innovation ecosystem, including regulatory systems and standards, financial support systems, and new market dynamics. IMPLICATIONS This article highlights the needs for more systemic analyses of the needs of potentially disruptive innovations, in RM and more widely, and for policymakers to give greater attention to these insights in planning regulatory and other supporting initiatives, with the promotion of innovation in mind.