The making of biotechnology: a case study of radical innovation

This study examines decision making in large and small firms undertaking biotechnology innovation and identifies factors influencing innovation. It also considers aspects of environments external to firms, but relevant to the process of innovation. The study suggests that innovation is best understood as process of change both within the firm and in the external environment. Factors internal to firms influencing key decisions included economic and political evaluations, company culture, organization, and in large firms, previous areas of corporate activity. A scarcity of appropriate knowledge relating to technical and non-technical aspects of innovation acted as severe restraints to Dedicated Biotechnology Firms (DBFs). Factors external to firms shaping decisions about the technology included changes in the socio-economic and political environment, risk regulation and patenting. Lack of funding and difficulties associated with venture capital constituted additional hurdles for DBFs. The findings of the study highlight a series of erroneous assumptions built into the linear model of innovation. The cumulative nature of innovation and the importance of 'learning by doing' constitute elements of the critique of the linear model. For related reasons, some Post Fordist theories of current change in advanced industrialized countries, particularly those which advocate flexible specialization as a new model for industrial growth also prove problematic

Advancing trial design in progressive multiple sclerosis

The failure of a majority of clinical trials in progressive multiple sclerosis (MS) has highlighted the need to reconsider how these trials are designed and conducted, and many areas deserve focus. Basic scientists are reconceptualising the pathophysiology of progressive MS into three broad areas: systemic inflammation, compartmentalized inflammation and non-inflammatory neurodegeneration, with the latter two becoming predominant as the disease progresses. This framework will guide the choice of experimental therapies. Previous clinical trials have highlighted how participant selection can have a significant impact on study outcome. Phase 2 biomarkers which are biologically stable, dynamically changing over time, and easy to assess in multi-centre studies are greatly needed. Shortcomings inherent in the Expanded Disability Status Scale are prompting the development and validation of better clinical measures. The standard two-arm, fixed-duration trial paradigm has been challenged with new, innovative approaches that can test more therapies efficiently. International collaboratives such as the Progressive MS Alliance will support increased dialogue with regulators, industry and other funding agencies. Better engagement with people living with progressive MS will transform them from simply being the recipient of MS therapies to partners in the search for new treatments. Focused, targeted action will drive further development of effective therapies for progressive MS