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Innovation Processes in Life Science Industries

James Mittra

Principal investigator(s):   Joyce Tait

February 1 2003 – January 31 2007

Theoretical contributions

Our empirical research into the changing nature, direction and management of life science-based innovations in the pharmaceutical industry are leading us to question the true impact of the life sciences on drug R&D and strategic alliance behaviour; the commitment of big pharma to pursue radically new approaches to healthcare; the sustainability of the ‘blockbuster’ syndrome; and the potential success of small and medium sized firms striving to become product providers.

Theoretically, this research addresses some of the core concerns of innovation studies and science and technology studies (STS); particularly recent work in networked/distributed innovation systems. Our research is beginning to challenge many of the assumptions and priorities within STS and innovation studies, in relation to the ways in which innovation models are conceived. The post War pharmaceutical industry has perhaps been one of the paradigmatic cases of linear, science-driven innovation models. Different models are apparent in other sectors and historical eras. STS needs greater reflexivity about how paradigms may reflect the choice of exemplary cases.

A key methodological challenge for both qualitative and quantitative studies in this area is how to identify what changes in drug discovery, development and delivery, as well as co-evolution of different types of firm - have been ‘determined’ by the emergence of particular types of ‘novel’ technologies.

Background

Life science innovations are having a significant impact on a variety of public sector organisations and commercial industries. In pharmaceuticals, new and complex re-alignments of companies and networks (through mergers, acquisitions, strategic alliances & licensing activities) have evolved as companies attempt to extract value from new life science technologies relevant to drug discovery, and respond to a variety of internal and external commercial pressures. This has the potential - in the pharmaceutical and health sectors - to fundamentally affect the existing processes of drug discovery, development and marketing. The promise of `genomics' is that drug discovery and approval processes will be expedited and that drugs will become more efficacious, cost effective and of greater therapeutic benefit to patients.

Focusing on the science and industry side of these issues, this Economic and Social Research Council funded project investigated the changing nature, direction and management of life science-based innovations in the pharmaceutical and health sectors. We are attempting to improve understanding of the complex and diverse strategies employed by different types of firm, and assess their impact on the scientific, technological and industrial landscape.

Aims and objectives

1) What impact are specific life science technologies and approaches to drug discovery having on both early and late stage R&D, and what are the principal scientific, technological and commercial challenges for industry?

2) How are companies' R&D models/strategies changing in response to the emergence of radically new technologies?

3) What has been driving the general trend towards merger, acquisition and strategic alliance behaviour in the pharmaceutical sector, and how do individual companies decide how best to balance in-house R&D with outsourcing, strategic alliances and licensing?

4) How is the relationship between traditional pharma companies and the SME biotech sector evolving and what will determine the future success of the SME?

5) What aspects of policy and regulation (nationally and internationally) do companies see as enabling and constraining innovation and commercial success?

6) How do general public and political perceptions of the industry - particularly expectations of safety and efficacy - affect company strategies?

Research methods

  • Case studies and interviews, with representatives of `big' and `medium' sized pharmaceutical companies, small and medium sized biotech companies, public sector research organisations and trade bodies
  • Document analysis of company websites, annual reports, press releases etc
  • Analysis of patent data and data from consultancy reports

Key findings

  • New Technologies have radically changed aspects of early-stage R&D, but not yet revolutionised downstream drug development.
  • Failure of Big Pharma to fully exploit the life sciences reflect current strategic/commercial priorities and uncertainties in the operating environment.
  • Strategies to extract value from new technologies dependent on internal firm-specific factors.
  • Diverse organisational models and strategies for improving the health innovation cycle have emerged; challenging the notion of a single Big Pharma model.
  • Despite emphasis on distributed innovation systems and new therapeutic foci, the traditional ‘blockbuster’ approach persists.
  • Uncertainties of the external regulatory/policy environment, and growth of the biotech sector, continues to challenge traditional strategies.

Publications

Mittra, J. (2007) The Impact of Life Science Innovations on the Organisation and Strategic Management of Pharmaceutical R&D (Submitted to Industry and Innovation)

Mittra, J., and Williams, R. (2007) Editorial: Evolution of the Life Science Industries, Technology Analysis and Strategic Management, Special Issue, 19 (3), pp. 251-255

Mittra, J. (2007) Life Science Innovation and the Re-structuring of the Pharmaceutical Sector: Mergers, Acquisitions and Strategic Alliances, Technology Analysis and Strategic Management, 19 (3), pp. 279-301

Tait, J. (2007) Systemic Interactions in Life Science Innovation, Technology Analysis and Strategic Management, 19 (3), pp.257-277

Mittra, J. (2006) The Socio-Political Economy of Pharmaceutical Mergers: A Case study of Sanofi and Aventis, Technology Analysis and Strategic Management, 18 (5), pp. 473-496

Mittra, J. and Tait, J. (2006) Public-Private Partnerships in Translational Medicine: Scotland’s Translational Medicine Research Collaboration, Case study prepared for OECD Expert workshop on Emerging Research Models for the Delivery of Health Innovation (this case study will soon be published in an OECD report)

Tait, J., and Mittra, J. (2006) ‘Singing from the same Hymn Sheet: Can Genomics Harmonise with Chemistry?’ CHEManager, August, 2006, p.14

Tait, J. & Mittra. J. (2005) Big Pharma: Coping with Complexity, ESRC Genomics Network Newsletter, Issue 2, June 2005

Mittra, J. (2005) Pharmaceutical Industries: Do They Prefer Treatment to Cure? The Biochemist 27 (3): pp. 32-34

Tait, J. & Mittra, J. (2004) Industry Challenges, Chemistry and Industry, 6 December, 2004, No. 23, pp. 24

Mittra, J., Suk, J & Tait, J. (2007) Risk Governance of Stem Cells as Therapeutic Products, RiskBridge essay, May 2007

Mittra, J. (2007) Changing Strategies of Big Pharma, Innogen Policy Brief

Tait, J. (2007) Creative Disruption in Life Science Industries, Innogen Policy Brief

Further information

For further information contact James Mittra, james.mittra@ed.ac.uk