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Designer Therapeutics: The Way Forward or an Economic Impossibility? · 28 December 04
The current trend in discussions regarding the future of therapeutics for refractory diseases, with autoimmune disease being very much a case in point, is to identify a need to stratify patients according to factors such as their genetic make-up, biomarker expression or microbial flora. This aim is admirable as regards the prospects for development of targeted, efficacious therapeutics with improved long-term prognosis and decreased risk of side effects.
Nonetheless, it is noticeable that pharmaceutical companies have not embraced this apparent reality with open arms. The initiation of patient subgroup-focused drug development programs, or clinical trials that only explore particular patient subgroups, has shown no signs of being implemented. At best, this has been used in retrospective analyses of clinical trials that did not reach their primary endpoint, or where there was limited or no efficacy of therapeutics that appeared promising in pilot trials; as has been the case after the limited success of natalizumab in phase II clinical trials for Crohn’s disease.
This apparent conundrum has one very clear answer, that of economics. What hope is there in our current pharmaceutical company-controlled drug development paradigm, for example, for an expensive biological therapeutic that will at best be one of several options for 25% of the patient population (the frequency of NOD2, the most common identified genetic abnormality associated with CD). If such translational research is to be the future for drug development, then a serious assessment of the climate required to nurture such development is necessary.