OpportunityTitle: Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Eligible OrganizationsHigher Education Institutions&#8226; Public/State Controlled Institutions of Higher Education &#8226; Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education&#8226; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#8226; Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#8226; Small Businesses&#8226; For-Profit Organizations (Other than Small Businesses)Governments&#8226; State Governments &#8226; County Governments&#8226; City or Township Governments&#8226; Special District Governments&#8226; Indian/Native American Tribal Governments (Federally Recognized) &#8226; Indian/Native American Tribal Governments (Other than Federally Recognized)&#8226; U.S. Territory or PossessionOther&#8226; Independent School Districts&#8226; Public Housing Authorities/Indian Housing Authorities&#8226; Native American Tribal Organizations (other than Federally recognized tribal governments)&#8226; Faith-based or Community-based Organizations&#8226; Regional Organizations
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.
GrantorContactEmailDescription: work email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592