A recent article by Ryan McBride in biotech industry newsletter FierceBiotech (http://dtg.fm/i12W) highlights a major transition that needs to occur in the pharmaceutical industry.
The article points to a speech by Ken Kaitin, director of the Tufts Center for the Study of Drug Development, suggesting that drug development companies need to fix broken areas of development that are costing them billions of dollars from unnecessary procedures in clinical trials. Kaitin’s group expects pharma to replace traditional trial-and-error testing methods with newer approaches, such as biomarkers, modeling, and simulation, all in an effort to reduce failures and associated costs, costs which payers are increasingly reluctant to accept.
It’s exactly the issue that is being addressed by VistaGen Therapeutics’ proprietary stem cell technologies. VistaGen is a California-based biotechnology company applying its human pluripotent stem cell technology for drug rescue applications, including predictive toxicology and drug metabolism screening. The company intends to use its proprietary technology to discover, rescue, and develop novel drug candidates for a wide range of diseases.
The company’s platform, Human Clinical Trials in a Test Tube, is based on the differentiation of human pluripotent stem cells into multiple types of mature human heart and liver cells which can then be used to provide clinically relevant predictions of potential toxicity. Determination of toxicity at these early stages, far earlier than standard clinical trials, means that drug candidates have a chance of being modified for a successful outcome, saving tremendous amounts of money.
Many otherwise promising drug candidates have been shelved due to toxicity issues that surfaced well into the development and introduction process, representing major losses for drug companies. It suggests a growing recognition of the incredible value offered by technologies such as those VistaGen represents.
For additional information, visit www.VistaGen.com
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