FDA Inks Research Collaboration with AnaBios

AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function.
 
Under the RCA, the FDA Center for Drug Evaluation and Research (CDER) and AnaBios will evaluate functional human primary cardiomyocytes as standards for reference of gene expression, localization of functional proteins and sensitivity of their functional properties to inotropic drugs, i.e. those that affect the strength of cardiomyocyte contractility.  
 
"AnaBios is pleased to collaborate with the FDA at a time when the importance of human translational research in preclinical drug discovery remains high," said Najah Abi-Gerges, vice president of research and development, AnaBios. "AnaBios routinely conducts physiology studies employing adult human primary cardiomyocytes. This project will provide new information about the biology of cells that play a critical role in normal and pathological human heart function. We anticipate the results of this collaboration will significantly advance drug discovery strategies and safety pharmacology."
 
The outcome of this collaboration will contribute to the FDA's ongoing effort to evaluate new drug development tools based on in vitro cellular systems. Currently, it is difficult to confidently evaluate drug-induced variations in cardiomyocyte function and biological properties due to lack of baseline and human-specific information. 
 
AnaBios isolates viable cardiac muscle tissue and cardiomyocytes from ethically consenting human donors. The evaluation developed under this FDA collaboration will define baseline parameters for the expression of cardiac genes, originate image-based training sets for healthy localization and organization of functional proteins, and provide information on the ranges of inotrope concentrations that affect human cardiac muscle contraction. These results will help support future evaluations of cellular systems for predicting cardiac effects of pharmaceutical drugs.

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