Challenges for the development of new treatments for severe asthma: a pharmaceutical perspective.

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.