Literature DB >> 23567075

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

Jennifer B Pierson1, Brian R Berridge, Marjory B Brooks, Kevin Dreher, John Koerner, A Eric Schultze, R Dustan Sarazan, Jean-Pierre Valentin, Hugo M Vargas, Syril D Pettit.   

Abstract

INTRODUCTION: The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues are a major cause of attrition and withdrawal due to adverse drug reactions (ADRs) in pharmaceutical drug development.
METHODS: The evolution of the HESI Technical Committee on Cardiac Safety from 2000-2013 is presented as an example of an effective international consortium of academic, government, and industry scientists working to improve cardiac safety. RESULTS AND DISCUSSION: The HESI Technical Committee Working Groups facilitated the development of a variety of platforms for resource sharing and communication among experts that led to innovative strategies for improved drug safety. The positive impacts arising from these Working Groups are described in this article.
Copyright © 2013 Elsevier Inc. All rights reserved.

Keywords:  ADRs; Animal models; CDER; CV; Cardiac biomarkers; Cardiac repolarization; Cardiac safety; Center for Drug Evaluation and Research; ECG; EMA; EWG; European Medicines Agency; Expert Working Group; FDA; HESI; Health and Environmental Sciences Institute; ICH; IKr; ILSI; ILSI/HESI; IND; Integrated risk assessment; International Conference on Harmonization; International Life Sciences Institute; JPMA; Japanese Pharmaceutical Manufacturer Association; NDA; PRODACT; PSTC; Predictive Safety Testing Consortium; QTc; SC-CM; Stem cells; TQT; TdP; US FDA; United States Food and Drug Administration; adverse drug reactions; cTn; cardiac troponin; cardiovascular; corrected QT interval; delayed rectifier potassium current; electrocardiogram; hERG; human ether-á-go-go related gene; investigational new drug; new drug application; project for database construction; stem-cell derived cardiac myocytes; thorough QT study; torsades de pointes

Mesh:

Year:  2013        PMID: 23567075     DOI: 10.1016/j.vascn.2013.03.008

Source DB:  PubMed          Journal:  J Pharmacol Toxicol Methods        ISSN: 1056-8719            Impact factor:   1.950


  6 in total

1.  In vitro cardiotoxicity assessment of environmental chemicals using an organotypic human induced pluripotent stem cell-derived model.

Authors:  Oksana Sirenko; Fabian A Grimm; Kristen R Ryan; Yasuhiro Iwata; Weihsueh A Chiu; Frederick Parham; Jessica A Wignall; Blake Anson; Evan F Cromwell; Mamta Behl; Ivan Rusyn; Raymond R Tice
Journal:  Toxicol Appl Pharmacol       Date:  2017-03-01       Impact factor: 4.219

2.  A Novel Phenylchromane Derivative Increases the Rate of Glucose Uptake in L6 Myotubes and Augments Insulin Secretion from Pancreatic Beta-Cells by Activating AMPK.

Authors:  Naomi Rozentul; Yosef Avrahami; Moran Shubely; Laura Levy; Anna Munder; Guy Cohen; Erol Cerasi; Shlomo Sasson; Arie Gruzman
Journal:  Pharm Res       Date:  2017-10-05       Impact factor: 4.200

Review 3.  Evaluation of drug-induced QT interval prolongation in animal and human studies: a literature review of concordance.

Authors:  Hugo M Vargas; Alan S Bass; John Koerner; Sherri Matis-Mitchell; Michael K Pugsley; Matthew Skinner; Matthew Burnham; Matthew Bridgland-Taylor; Syril Pettit; Jean-Pierre Valentin
Journal:  Br J Pharmacol       Date:  2015-07-14       Impact factor: 8.739

Review 4.  ILSI Health and Environmental Sciences Institute (HESI), global leader in advancing translational science to create science-based solutions for a sustainable, healthier world.

Authors:  Ayako Takei
Journal:  Genes Environ       Date:  2015-06-16

5.  Effects of repeated restraint and blood sampling with needle injection on blood cardiac troponins in rats, dogs, and cynomolgus monkeys.

Authors:  Keisuke Nagata; Kazutoshi Sawada; Hirofumi Minomo; Daisuke Sasaki; Katsuyuki Kazusa; Kazuhiko Takamatsu
Journal:  Comp Clin Path       Date:  2017-08-24

Review 6.  Novel screening techniques for ion channel targeting drugs.

Authors:  Alison Obergrussberger; Sonja Stölzle-Feix; Nadine Becker; Andrea Brüggemann; Niels Fertig; Clemens Möller
Journal:  Channels (Austin)       Date:  2015-11-10       Impact factor: 2.581

  6 in total

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