Making the Most of Innovation in Personalised Medicine: An EU Strategy for a Faster Bench to Bedside and Beyond Process

摘要

Personalised medicine promises to revolutionise healthcare, with its key goal of providing the right treatment to the right patient at the right time, and thus the potential of improving quality of life and helping to bring down healthcare costs. However, a major problem with broader implementation of personalised medicine is patient access to new drugs, devices and treatments. The fact that a new medicine or innovative product can sometimes take as long as 20 years to get from bench to bedside is not only clearly undesirable but is arguably unacceptable in the 21st century. This paper looks in detail at the issues surrounding development, continued investment, risk factors, testing and approval from both the industry perspective as well as that of the assessor and the decision maker/payer. It becomes clear that there is a lack of working in tandem that results in a double time frame (two times 10 years). This is simply because the key stakeholders, surprisingly, do not synergise their assessments of a new product. As well as causing delays in patient access, this can also affect investment confidence as industry waits too long for approval for its product to reach the market and its subsequent implementation into healthcare. Such a slow process undermines continued investment and contributes to a risk-averse environment, which in turn can have an impact on innovation. The solution appears to be uncomplicated, involving better coordination and collaboration between the different stakeholders working at various stages within the bench-to-bedside timeframe. We take the example of the network of the European Alliance for Personalised Medicine (EAPM) to demonstrate possible solutions using an innovative approach. (C) 2019 S. Karger AG, Basel