Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)
ArchivedFood and Drug Administration
Description
Cardiovascular toxicity is a leading cause of drug attritionin drug development. Proarrhythmia, QT prolongation and Torsade de Point (TdP)contribute the most to this attrition and these outcomes drive the effortsspent to eliminate them from the drug discovery pipeline. Currently, theseendpoints are evaluated through invivo preclinical studies followed by a thorough-QT (TQT) study inthe clinical phase. T FDA seeks new assays to replace non-clinical cardiotoxicity assessments.Specific interest is in assays based on human cells or materials, collectivelycovering the spectrum of cardiotoxic drug effects.
Who can apply
- State governments
- City or township governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Private institutions of higher education
- Small businesses
- Others
Contact
Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov
- PostedJan 31, 2019
- ClosesApr 4, 2019
- Award floor$500,000
- Award ceiling$1,500,000
- Program funding$1,500,000
- Expected awards1
- CFDA93.103
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