Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting.
David G StraussGary GintantZhihua LiWendy WuKsenia BlinovaJosé VicenteJ Rick TurnerPhilip T SagerPublished in: Therapeutic innovation & regulatory science (2018)
A Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA-sponsored Think Tank Meeting was convened in Washington, DC, on May 21, 2018, to bring together scientists, clinicians, and regulators from multiple geographic regions to evaluate progress to date in the Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative, a new paradigm to evaluate proarrhythmic risk. Study reports from the 4 different components of the CiPA paradigm (ionic current studies, in silico modeling to generate a Torsade Metric Score, human induced pluripotent stem cell-derived ventricular cardiomyocytes, and clinical ECG assessments including J-Tpeakc) were presented and discussed. This paper provides a high-level summary of the CiPA data presented at the meeting.
Keyphrases
- left ventricular
- human health
- public health
- healthcare
- high glucose
- endothelial cells
- high throughput
- mental health
- health information
- heart failure
- dendritic cells
- palliative care
- risk assessment
- health promotion
- quality improvement
- heart rate variability
- emergency department
- molecular docking
- electronic health record
- immune response
- oxidative stress
- big data
- ionic liquid
- drug induced
- social media
- atrial fibrillation
- molecular dynamics simulations
- deep learning
- catheter ablation
- solid state