Refractory Respiratory Inflammation Biology, Respiratory Therapy Area Unit, GlaxoSmithKline R & D, Stevenage, Hertfordshire, UK.
Curr Pharm Des. 2011;17(7):699-702. doi: 10.2174/138161211795429019.
The pharmaceutical industry is interested in developing new treatments for severe asthma (SA), recognising that there is a substantial unmet clinical need in this area. However, it faces a significant set of barriers in attempting to do so, including a) problems arising from the way SA is defined, b) the heterogeneity of this condition, c) poor understanding of its aetiology, d) the absence of validated animal and tissue or cellular models, e) the need for biomarkers and experimental clinical models of severe asthma and its sub-groups, and f) the length and size of the clinical trials likely to be required to obtain approval and reimbursement. The discovery and validation of novel biomarkers and surrogates is likely to be a crucial part of meeting these challenges, and many academic groups and pharmaceutical companies working in this area are increasingly turning to pre-competitive, highly collaborative ways of working to address them.
制药行业有兴趣开发治疗严重哮喘 (SA) 的新方法，因为认识到这一领域存在着巨大的未满足的临床需求。然而，在尝试这样做时，制药行业面临着一系列重大障碍，包括：a）SA 的定义方式所产生的问题；b）这种疾病的异质性；c）对其病因的理解不足；d）缺乏经过验证的动物和组织或细胞模型；e）需要严重哮喘及其亚组的生物标志物和实验临床模型；f）为获得批准和报销而可能需要进行的临床试验的时长和规模。发现和验证新型生物标志物和替代物可能是应对这些挑战的关键部分，许多在该领域工作的学术团体和制药公司越来越倾向于采用竞争前、高度协作的工作方式来解决这些问题。
