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NIH Awards Cellular Dynamics International SBIR Grant to Develop Human Cardiomyocytes for Drug Screening
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Cellular Dynamics International (CDI) announced that it has received a Small Business Innovation Research (SBIR) grant from the NIH worth $499,796 to develop pluripotent stem-cell derived human cardiomyocytes (CMs), or heart cells. Human CMs will provide a predictive model to determine cardiotoxicity in the early stages of drug development.
Cardiac safety concerns have become one of the leading causes of drug failure in the pharmaceutical industry. Currently the FDA mandates both preclinical and clinical cardiac safety studies for all new drugs in development. The purpose of these studies is to predict if a drug will cause dangerous, possibly lethal, side-effects in humans.
Current methods of cardiotoxicity prediction rely on multiple models with limited utility due to their animal (non-human) or non-cardiac origin, hurdles that add to the uncertainty and already high costs of drug development.
With this SBIR grant, CDI will use human pluripotent stem cells to derive pure populations of cardiomyocytes (atrial, ventricular, and nodal) for development of preclinical models to predict cardiac toxicity in humans during the early stages of drug discovery. These models will allow for early detection of drug toxicity and significantly reduce the chances of a cardiotoxic compound from ever reaching a clinical population, thus improving the overall efficiency and safety of the drug development process.
“A clear priority for the pharmaceutical industry is to be able to detect the potential toxicity of a compound long before evaluating it in patients,” said CDI founder Craig January, a leading international authority in the field of cardiac arrhythmias and a practicing cardiologist and professor at the University of Wisconsin-Madison, School of Medicine and Public Health.
Chris Kendrick-Parker, CDI Chief Commercial Officer, concurs, “We believe that cardiac safety testing can best be accomplished using human cardiomyocytes, and this NIH grant enables CDI to build on our innovative pluripotent stem cell technology to create these cells in quantities required for drug development.”
This is the second SBIR grant awarded CDI this year, with a combined total of approximately $1 million.
