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Increasing FDA Requirements Underline the Importance of VistaGen Therapeutics Inc. (VSTA)

|Includes: VistaGen Therapeutics, Inc. (VTGN)

On Thursday last week, when PPD, Inc., a leading global contract research organization, gave a presentation relating to current issues in cardiac safety, and the impact it has on drug development, it was clearly a hot topic for many listeners involved in bringing new drugs to market. An informal poll taken during the online presentation indicated that over 90% of involved listeners felt that cardiac safety was a clear factor in the drug development process.

PPD is known for providing drug discovery, development, and life cycle management services for pharmaceutical and other companies, as well as for government organizations, and has offices in 44 countries around the world. The presentation was given by Rob Dow, VP of Strategic Product Development at PPD, and Robert Kleiman, MD, Chief Medical Officer and VP of Global Cardiology at ERT, an industry leader in cardiac safety drug research.

One of the points emphasized in the presentation was the fact that the U.S. Food and Drug Administration now requires cardiovascular outcomes evaluation for non-cardiovascular drugs in several therapeutic areas, all of which can significantly impact drug development. Today, so-called blockbuster drugs can lead to the exposure of millions of patients. Previous high-profile market withdrawals of FDA-approved drugs involving cardiovascular safety issues, and the associated public outcry, fueled major changes in what is required by drug developers to ensure cardiovascular safety. Given traditional testing methods, which are used late in the preclinical development process, it adds another layer of complexity and expense for drug developers.

The issue of cardiovascular safety for new drugs underlines the importance of VistaGen’s developments in clinically relevant cardiovascular toxicity testing before new drug candidates are ever tested in humans. Just when it is needed most, VistaGen’s Human Clinical Trials in a Test Tube platform, using advanced stem cell technology, is an important new tool for the pharmaceutical industry, allowing companies to accurately test for potential cardiovascular toxicity in the early preclinical stages of drug development, offering potential far-reaching savings in time and money. Instead of going through the tremendous investments necessary for developing a new drug, only to have it shot down in the last stages by unexpected cardiovascular toxicity issues, the risks can now be identified up front, and steps taken to rescue and re-engineer the drug candidate.

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