Personalized medicine (syn.: individualized medicine, stratified medicine, or precision medicine) strives at consideration of individual molecular and genetic features beyond the mere diagnosis with the aim of a tailored treatment.
Molecular characteristics of the disease become determined based on biomarkers and use of dedicated molecular diagnostic tests, so-called companion diagnostics. This allows assignment of patients into subgroups for which a targeted therapy is available. In addition, the patient´s genetic make-up (genome) plays a role with regard to how drugs are metabolized and therefore with efficacy and safety of these drugs.
Consideration of these aspects in clinical research and development but also in clinical routine has the potential to increase efficacy and safety of treatment and therefore clearly serves the benefit of patients. This provides opportunities for better allocation of resources and avoidance of additional therapy due to adverse events.
On the one hand personalized medicine adds complexity to drug development. On the other hand, however, it also offers the opportunity to speed up the lengthy, expensive, and high risk drug development process, to make it more promising and to realize cost savings through a more targeted approach. And the safer and the more effective a drug appears to be, the less complicated it is to achieve premium price.
Finally, there are also opportunities for the diagnostics industry since targeted therapies are tailored to the respective diagnostic test, which needs to be developed and approved in a concurrent manner.
Personalized medicine has picked up in recent years but still goes along with highly complex and new requirements for strategic development and commercialization of such therapeutic concepts.