ESRC Innogen Centre, Old Surgeons' Hall, High School Yards, University of Edinburgh, EH1LZ, UK.
Trends Biotechnol. 2011 Mar;29(3):105-9. doi: 10.1016/j.tibtech.2010.11.004. Epub 2010 Dec 14.
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.
制药和农业生物技术行业面临着产品管线萎缩和生命科学快速发展的挑战,因此需要对传统的研发进行战略思考。尽管生命科学为这两个行业提供了解决产品管线问题的方案,但也给企业带来了复杂的监管挑战。本文在成熟的传统小分子产品管线和进入市场的途径的背景下,对这些行业对生命科学轨迹的反应进行了评论。讨论了从成熟到新的高附加值创新模式管理转型的挑战。此外,我们认为监管在塑造这两个行业的创新体系方面发挥着至关重要的作用,因此,我们建议对现行监管制度进行可能有用的改革。