Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G. Strauss; Gary Gintant; Zhihua Li; Wendy Wu; Ksenia Blinova; Jose Vicente; J. Rick Turner; Philip T. Sager

doi:10.1177/2168479018795117

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G. Strauss, Gary Gintant, Zhihua Li, Wendy Wu, Ksenia Blinova, Jose Vicente, J. Rick Turner, Philip T. Sager

Obstetrics and Gynecology

Research output: Contribution to journal › Article › peer-review

71 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	519-525
Number of pages	7
Journal	Therapeutic Innovation and Regulatory Science
Volume	53
Issue number	4
DOIs	https://doi.org/10.1177/2168479018795117
State	Published - Jul 1 2019

Keywords

CiPA
J-Tpeakc
balanced ion channel-blocking drugs
human induced pluripotent stem cell-derived ventricular cardiomyocytes
torsade de pointes
torsade metric score

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

Access to Document

10.1177/2168479018795117

Cite this

Strauss, D. G., Gintant, G., Li, Z., Wu, W., Blinova, K., Vicente, J., Turner, J. R., & Sager, P. T. (2019). Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Therapeutic Innovation and Regulatory Science, 53(4), 519-525. https://doi.org/10.1177/2168479018795117

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. / Strauss, David G.; Gintant, Gary; Li, Zhihua et al.
In: Therapeutic Innovation and Regulatory Science, Vol. 53, No. 4, 01.07.2019, p. 519-525.

Research output: Contribution to journal › Article › peer-review

Strauss, DG, Gintant, G, Li, Z, Wu, W, Blinova, K, Vicente, J, Turner, JR & Sager, PT 2019, 'Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting', Therapeutic Innovation and Regulatory Science, vol. 53, no. 4, pp. 519-525. https://doi.org/10.1177/2168479018795117

@article{9371254c2cd14e2496cd73892a396129,

title = "Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting",

abstract = "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.",

keywords = "CiPA, J-Tpeakc, balanced ion channel-blocking drugs, human induced pluripotent stem cell-derived ventricular cardiomyocytes, torsade de pointes, torsade metric score",

author = "Strauss, {David G.} and Gary Gintant and Zhihua Li and Wendy Wu and Ksenia Blinova and Jose Vicente and Turner, {J. Rick} and Sager, {Philip T.}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2018.",

year = "2019",

month = jul,

day = "1",

doi = "10.1177/2168479018795117",

language = "English (US)",

volume = "53",

pages = "519--525",

journal = "Therapeutic Innovation and Regulatory Science",

issn = "2168-4790",

publisher = "SAGE Publications Inc.",

number = "4",

}

TY - JOUR

T1 - Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

AU - Strauss, David G.

AU - Gintant, Gary

AU - Li, Zhihua

AU - Wu, Wendy

AU - Blinova, Ksenia

AU - Vicente, Jose

AU - Turner, J. Rick

AU - Sager, Philip T.

N1 - Publisher Copyright: © The Author(s) 2018.

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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.

AB - 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.

KW - CiPA

KW - J-Tpeakc

KW - balanced ion channel-blocking drugs

KW - human induced pluripotent stem cell-derived ventricular cardiomyocytes

KW - torsade de pointes

KW - torsade metric score

UR - http://www.scopus.com/inward/record.url?scp=85053422768&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85053422768&partnerID=8YFLogxK

U2 - 10.1177/2168479018795117

DO - 10.1177/2168479018795117

M3 - Article

AN - SCOPUS:85053422768

SN - 2168-4790

VL - 53

SP - 519

EP - 525

JO - Therapeutic Innovation and Regulatory Science

JF - Therapeutic Innovation and Regulatory Science

IS - 4

ER -

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this