The Age of Personalized Medicine Is Near

Posted: October 31, 2012 at 10:04 pm

By Chris Wood, Casey Research

Today, personalized medicine seeks to move away from the one-size-fits-all, trial-and-error approach that has defined drug R&D and patient treatment basically since the time of Galen of Pergamon in the 2nd century AD. It increasingly focuses on matching the biological characteristics of each person with the best treatment options available and dosing for them, and in the future even perhaps the development of specific drugs for specific patients.

Truth be told, the idea of personalized medicine is nothing new. Back in the late 1800s, Canadian physician Sir William Osler (who was one of the founding professors at Johns Hopkins Hospital and has been called the "father of modern medicine") said, "Variability is the law of life, and as no two faces are the same, no two bodies are alike, and no two individuals react alike, and behave alike under the abnormal conditions which we know as disease."

Pathologists also often cite George Merck, who was talking about developing pharmaceutical agents directed toward individual patients rather than to groups of patients some sixty years ago, at the dawn of the era of personalized medicine.

Even though the idea has been around for some time, personalized medicine as a practice is quite new. Even just twenty years ago, virtually all drugs being developed attempted to target the entire population of a disease group rather than a subset or segment of it.

But all that is changing. Now, the development of drugs that are specifically linked to diagnostic tests that indicate a subgroup of patients is more likely to respond to treatment is often the goal for a variety of different diseases... particularly cancer.

Biomarkers are the key to this changing landscape in drug development and patient care. Biomarkers have the ability to help drug companies and physicians shrink costs, predict and minimize risk, avoid late-stage attrition, and make better, more informed decisions throughout the process. And they are poised to be the major driver of pharmaceutical research and drug development in the 21st century.

Originally, the term "biomarker" just referred to simple physiological indicators such as body temperature, blood pressure, or heart rate that signaled an imbalance in the body or evidence of disease.

Today, many different types of biomarkers have been identified by scientists. They still include things that are simple to measure and correlate, such as high blood pressure as an indicator for increased risk of stroke. But they also include more complex genetic changes or mutations that can, for instance, help identify a patient's risk for particular type of cancer. For example, mutations in the so-called BRCA genes are known to increase a woman's risk of developing breast or ovarian cancer.

Renowned oncology expert Dr. Jeffrey Ross defines a biomarker as "a series of gene sequences and mutations, messenger RNA expression profiles, tissue proteins, and blood based tests that can be used to detect the predisposition for disease, screen for its presence, confirm its diagnosis, assess its severity, predict its response to available therapies, and monitor its clinical course."

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The Age of Personalized Medicine Is Near

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