Genomics personalized medicine

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Personalized medicine, which uses genetic information to tailor treatments to specific individuals, is a revolutionary healthcare option, filled with potential but also containing serious challenges for average patients

1.  Description

2.  Why

3.  How

4.  Future Trends

5.  Related Links

Description

Personalized medicine is use of information and data from a patient's genotype, or level of gene expression to stratify disease, select a medication, provide a therapy, or initiate a preventative measure that is particularly suited to that patient at the time of administration.In addition to genetic information, other factors, including imaging, laboratory, and clinical information about the disease process or the patient play an equally important role. 

Why 

Personalized medicine makes it possible to give:

  • The appropriate drug,
  • At the appropriate dose,
  • To the appropriate patient,
  • At the appropriate time

The benefits of this approach are in its accuracy, efficacy, safety and speed. The term emerged in the late 1990s with progress in the Human Genome Project.A great number of patients suffer adverse side-effects from prescribed medicines. Deaths (as a consequence of adverse side-effects) are statistically very significant. If a product, such as Vioxx, has to be recalled from the market, the consequences are far reaching and enduring.Despite spending in the region of $27 billion and employing the genius of almost 200,000 scientists on research and development, very few new, unique therapeutics have emerged over the past decade.

How

Research findings over the past decade, or so, in biomedical research have unfolded a series of new, predictive sciences that share the appendage -omics (genomics, proteomics, lipidomics, metabolomics, cytomics). These are opening the possibility of a new approach to drug development as well as unleashing the potential of significantly more effective diagnosis, therapeutics, and patient care.Owing to the complexity of drug actions, a broader genomics  approach aims at finding new drug targets and optimizing therapy for the individual patient. However, pharmaco has made only a few inroads into clinical practice to date.Many established branded blockbuster drugs are coming, or have already, come to the end of their patent-protected lives. These products can typically lose up to 40% market share in the year following patent expiry as generic alternatives become available. Consumer knowledge is making the market more cost sensetive.Cancer genetics is a subspecialized field of genetics. This field initially dealt with the relatively small amount of inherited cancers. This amounted to about 5-10% of all cancers as estimated by the National Institutes of Health.Individuals diagnosed with familial breast, ovarian, colon cancer had been counseled in the past that they would receive standardized treatments and had limited options before their "condition" arrived. These options included removal of the organs that may give rise to cancer. Recent medical research indicates that medications, lifestyle changes and increased screening can mitigate some risk.Laboratories that support personalized molecular medicine develop patient-specific tests that monitor the effectiveness of treatment and can identify the recurrence of disease far earlier than was once possible. 

Future Trends

It costs an average of $1 billion and 12 to 15 years to develop a new therapeutic and further $1 billion to successfully market a new product. The failure rate of product development is very high and in many cases failure is not evident until a great proportion of this investment has been committed to large scale clinical trials.New discoveries about genes that are important in drug treatment and also diagnostic tests. The next step now is proof of concept--proving the difference that personalized medicine makes.

Keywords

Personalized medicine, appropriate drug, adverse side-effects, Pharmacogenetics, FDA. 

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