Why do pharmaceutical drugs cost so much? Because pharmaceutical companies waste so much money and time developing them.
But these companies can be excused for wasting hundreds of millions of dollars and years of work developing drugs that won't be approved for use. The conventional method for initially testing the effectiveness and toxicity of these drugs - testing on animals - is terribly ineffective.
While scientific models like animals can provide a clue of how a drug might affect a human, they can never truly replicate the effects of giving the drug to people. Drugs that might not work in animal models - or even cause harmful effects - could produce an entirely different outcome when given to humans. But before government regulators will allow a drug to be tested on humans, it has to be proven safe in costly clinical trials with animal models or in vitro cell culture testing systems.
Drugs are scrapped every year by pharmaceutical companies after toxicity issues are discovered. The drugs are soon forgotten as the companies move on to find the next "wonder drug." If scientists had a more accurate scientific model to perform initial tests on, they would be able to better predict which drugs are safe and which aren't long before large investments are made.
A San Francisco-based biotechnology company, VistaGen Therapeutics, is focused on changing all of this through its novel platform Human Clinical Trials in a Test Tube™. The platform uses proprietary and exclusively-licensed stem cell technologies, some co-developed by Dr. Gordon Keller, a world renowned stem cell scientist.
In addition to providing toxicity predations for new drugs, the platform is designed to "rescue" once-promising small molecule drug candidates that were shelved because they exhibited negative effects in studies using conventional scientific models. Development of these drug candidates are often halted due to signs of heart or liver toxicity or metabolism issues during tests using scientific models like animals or in vitro cell culture testing systems.
The Human Clinical Trials in a Test Tube platform enables controlled differentiation of pluripotent stem cells into mature human cells, which are a more accurate model for clinical trials. The platform helps scientists determine if the negative effects experienced in previous trials with conventional models apply to humans. It can also be used to help generate new, safer variants in combination with modern medicinal chemistry.
By developing scientific models which more closely approximate human biology, VistaGen is helping pharmaceutical companies more accurately assess how new drug therapies will perform in clinical trials. The Human Clinical Trials in a Test Tube platform also provides useful clinical data earlier in the drug development process - so drug companies will know sooner which drugs might work … and which drugs won't. Having this information much sooner in the development cycle will help increase the efficiency of clinical trials and eliminate the waste of valuable resources.
For more information, visit VistaGen at VistaGen.com
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