Tuesday, November 5, 2024

Tuesday, November 5, 2024

ANABIOS: FDA Awards AnaBios Contract to Obtain Critical Translational Data from Ex Vivo Human Cardiac Platform


AnaBios issued the following announcement on Nov. 5.

The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.

"AnaBios is very honored to receive this contract from the FDA for this important project related to the cardiac safety assessment of drugs," said Dr. Paul E. Miller, co-founder and Chief Corporate Development Officer of AnaBios. "For over a decade, AnaBios has worked diligently to develop a translational ex-vivo human heart platform. We anticipate this collaboration will deliver critical data that could improve future regulatory and pharmaceutical industry decision-making."

The award is a firm-fixed task order under the IDIQ, Electrophysiological and Contractility Assessment of Drugs on Primary Adult Ventricular Tissues. This research is expected to help the FDA characterize adverse drug effects and is consistent with the FDA's mission of protecting public health by ensuring the safety and efficacy of drugs available to patients.

About AnaBios

Located in San Diego, California, AnaBios aims to establish the safety and efficacy of novel compounds through its advanced, human-focused translational technologies. AnaBios primarily focuses on areas of high, unmet medical need, including cardiac disease, pain and itch. In addition to working with Fortune 500 biotech companies, CROs and academia, AnaBios drives an internal drug discovery platform via in-licensed programs from partners in the pharmaceutical industry. For more information about AnaBios, visit http://www.anabios.com.  

Original source can be found here.

More News

FDA Reporter