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Genetic Testing

Drug Development

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Drug Development

Personalized pharmaceutical has the promise of improving drug development. Personalized pharmaceuticals can improve the chances of the drug being effective, reduce the risk of serious side effects, reduce the cost of drug development, and shorten the clinical trial.

By testing patients before they enter the clinical trial, pharmaceutical companies can choose drug trial participants who will mostly likely benefit from the drug. At first glance this scheme might seem like the pharmaceutical companies are gaming the clinical trials system, but this approach helps both patients and regulators.  By picking patients based who are most likely to respond to the drug and not have serious side effects, personalized medicine improves the outcomes of patients both in the trail and those who receive the drug after it has been approved. 

Personalized pharmaceuticals also take some of the guess work out of approving drugs for regulators.  The genetic tests limit the target population and better define how the drug interacts with the body, regulators can have higher confidence the drug will be both effective and safe. 

Pharmaceutical companies realize the benefits of testing their patients to see how the drug will affect them. Submissions with genetic testing information to the FDA have been increasing dramatically recently. And, the FDA has set up special division to handle joint diagnostic kit and drug systems.

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Pharmaceutical companies see the biggest benefit for personalized pharmaceuticals in reducing drug development cost. Right now, clinical failures and the time to test a drug account for most of a drug’s expense.


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For every one hundred drugs that start the clinical trials process, only 9 will be commercialized. And, the process takes 10-12 years. A substantial investment could be worth nothing in 12 years.

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By being able to choose those patients who will most likely respond to the drug, pharmaceutical companies can reduce the size of their clinical trials. In a typical clinical trial, only 40 to 60 percent of the patients respond to drug.  So the clinical trials must be made extremely large in order to find a significant number of patients who respond to the drug. These large patient pools with only a slight majority of responders means that the clinical trials must last a very long time. By shrinking the patient pool by only choosing patient who are likely to respond, the clinical trial’s duration can be greatly reduced. These benefits all add up to huge cost savings for the pharmaceutical companies and safer, more effective drugs for patients.

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