The pharmaceutical industry’s current drug development paradigm is supposed to assess whether a drug candidate is both safe and effective for use in the treatment of a given disease. It’s an approach that has been used for many years, involving animal and in vitro testing. However, the extremely high cost involved in developing today’s complex and potent drugs has exposed a serious problem. The conventional testing approach only approximates human biology. As a result, millions and even billions of dollars can be spent to get a drug to market, only to see it fail, sometimes after it has already been on the market, due to unanticipated heart or liver toxicity or sometimes adverse drug-drug interactions.
When a drug fails, the pharmaceutical company is often forced to simply discontinue the development program since the evaluation process has been shown to be ineffective. The drug is shelved, and the enormous sums of money spent on developing the drug are largely lost. It’s a horrible blow to the company, but also to the pharmaceutical industry and the public that it is meant to serve. The lost money must ultimately be made up, contributing to higher costs. In addition, a potentially life-saving drug is no longer available. And it’s a problem that is not uncommon. It has been estimated that fully one-third of all potential new drug candidates end up failing in preclinical or clinical trials due to safety concerns.
VistaGen, developers of a proprietary stem cell based drug assay system, is focused on addressing the growing problem of drug testing. Their Human Clinical Trials in a Test Tube platform offers superior testing that is based upon a closer approximation of human biology. Their system has the potential to identify human heart and liver toxicity issues in new drug candidates early in the development process, so that resources can be directed toward those candidates with the highest probability of success. It’s a technology designed to substantially reduce development costs, improving the economics of the current healthcare system, and enabling the creation of more effective and safer drugs.
For additional information, visit www.VistaGen.com
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