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Automated Contraction Analysis of Human Engineered Heart Tissue for Cardiac Drug Safety Screening
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Automated Contraction Analysis of Human Engineered Heart Tissue for Cardiac Drug Safety Screening

Published on: April 15, 2017

A public-private consortium advances cardiac safety evaluation: achievements of the HESI Cardiac Safety Technical

Jennifer B Pierson1, Brian R Berridge, Marjory B Brooks

  • 1Health and Environmental Sciences Institute, 1156 15th Street, Northwest, Suite 200, Washington, DC 20005, USA.

Journal of Pharmacological and Toxicological Methods
|April 10, 2013
PubMed

Insights

The HESI Technical Committee on Cardiac Safety improved drug development by fostering collaboration. This international consortium enhanced cardiac safety strategies and resource sharing, leading to better pharmaceutical safety.

Area of Science:

  • Pharmacology and Toxicology
  • Drug Development
  • Cardiovascular Safety

Background:

  • Cardiovascular side-effects are critical in drug and chemical development.
  • Cardiac safety issues frequently cause drug attrition and withdrawal due to adverse drug reactions (ADRs).

Purpose of the Study:

  • To present the evolution of the HESI Technical Committee on Cardiac Safety (2000-2013).
  • To highlight the committee's role as an international consortium improving cardiac safety.

Main Methods:

  • Describing the formation and activities of the HESI Technical Committee on Cardiac Safety.
  • Illustrating the collaborative efforts of academic, government, and industry scientists.

Main Results:

  • The HESI Technical Committee Working Groups fostered resource sharing and expert communication.
  • Innovative strategies for improved drug safety were developed through these collaborations.

Conclusions:

  • International collaboration through consortia like HESI is vital for advancing drug safety.
  • The HESI Technical Committee's work exemplifies successful strategies for mitigating cardiac risks in drug development.
Abstract

Keywords:
ADRsAnimal modelsCDERCVCardiac biomarkersCardiac repolarizationCardiac safetyCenter for Drug Evaluation and ResearchECGEMAEWGEuropean Medicines AgencyExpert Working GroupFDAHESIHealth and Environmental Sciences InstituteICHIKrILSIILSI/HESIINDIntegrated risk assessmentInternational Conference on HarmonizationInternational Life Sciences InstituteJPMAJapanese Pharmaceutical Manufacturer AssociationNDAPRODACTPSTCPredictive Safety Testing ConsortiumQTcSC-CMStem cellsTQTTdPUS FDAUnited States Food and Drug Administrationadverse drug reactionscTncardiac troponincardiovascularcorrected QT intervaldelayed rectifier potassium currentelectrocardiogramhERGhuman ether-á-go-go related geneinvestigational new drugnew drug applicationproject for database constructionstem-cell derived cardiac myocytesthorough QT studytorsades de pointes

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