Personalized Medicine

The term personalized medicine means the use of molecular analysis methods to better manage a patient's disease or disease predisposition. These methods include testing for variations in genes, gene expression, proteins, and metabolites. Test results are correlated with clinical factors-such as drug response, disease state, and treatment prognosis-and help physicians prescribe the most appropriate treatment for each patient.

Personalized medicines are anticipated to be a significant growth driver of the pharmaceutical market going forward, supported by a number of factors:

* More effective treatments for patients
By using personalized medicine to identify the right drug for a given patient, time wasted with ineffective or poorly tolerated therapies may be minimized. Also, it is more likely that patients' compliance to a drug will increase as they are more likely to experience the beneficial effects of a given therapeutic agent.

* Reduced drug development costs
Over $50 billion per year is devoted to biopharmaceutical research, a large proportion of which is spent on drugs that fail to ever reach the market. Often these drugs fail during the clinical trials as they may treat only a part of the patient population leading to clinical trials missing their statistical endpoints of the studies. Through a personalized, targeted approach to drug development molecular biological or pharmagenomic data can be used to pre-select patients for studies using only those likely to respond or less likely to suffer side effects. Although initially this approach may add some more cost to clinical development, it is likely to create greater rates of success in clinical trials with resulting savings in the costs of getting a drug to the market.

* Increased benefits to healthcare payers
The Genomics and Personalized Medicine Act in the United States refers to the fact that commonly used drugs are typically only effective in 40 - 60% of patients and up to 15% of hospitalized patients experience a serious adverse drug reaction. Using pharmacogenomics to prescribe only medicines that are likely to be effective in patients has the potential to increase efficacy and safety of drugs and therefore dramatically reduce the cost of healthcare. These savings can come from reduced spending on pharmaceutical therapies but also by avoiding poor healthcare outcomes due to ineffective treatments.

* Favorable regulatory environments
US and European regulators (FDA and EMEA) continue to support personalized medicine by implementing a series of guidelines that encourage the pharmaceutical industry to adopt these methods because of the benefits to patients.