The dream of tailor-made medication is not a new one, but the prospective cost of such treatments has always been a barrier to growth. Simply put, the return on compounds that only treat small populations cannot justify the investment. With life expectancy increasing and the cost of health care rising, however, an economic imperative is driving the change from managing sickness to managing wellness. A wellness-management approach detects conditions early, and hence the level of reversibility is high; the current reactive model has lower reversibility. With drugs targeted toward specific populations, the importance and acceptance of in silico modeling would increase. The author presumes that drug development programs will run more quickly, and that regulatory bodies would be able to approve drugs much earlier once a response in the target population has been proven. This is anticipated to reduce the clinical development time line and lead to cheaper drugs and prolonged exclusivity.
With the trend towards a lower acceptance of risk and thus bigger and more expensive clinical trials, do you agree with the author’s assumptions, especially given a smaller target population?
Source: Drug Discovery and Development