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This paper presents an approach developed by the Innogen Centre for the analysis of systems of innovation. The approach, developed through the study of innovation in the life sciences, is unique in that it features a triangular view, alongside consideration of the behaviours and interactions between innovators, regulators and policymakers, and advocacy and public interest groups. Furthermore, while the approach can be characterised as co-evolutionary and system-based, it also allows for the user to shift from the macro to micro — considering the impact of institutions on actors and innovation within an institutional milieu, but also considering the individual behaviours and business plans or actions of the actors involved. This paper presents both the approach itself and how the approach was developed. [ABSTRACT FROM AUTHOR]

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. [Copyright &y& Elsevier]