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协作科学的实践:来自健康与环境科学研究所(HESI)心脏安全委员会的 20 年展望。

Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) Cardiac Safety Committee.

机构信息

Health and Environmental Sciences Institute, Washington, DC, USA.

B2 Pathology Solutions LLC, Cary, NC, USA.

出版信息

J Pharmacol Toxicol Methods. 2024 May-Jun;127:107511. doi: 10.1016/j.vascn.2024.107511. Epub 2024 May 6.

Abstract

The Health and Environmental Sciences Institute (HESI) is a nonprofit organization dedicated to resolving global health challenges through collaborative scientific efforts across academia, regulatory authorities and the private sector. Collaborative science across non-clinical disciplines offers an important keystone to accelerate the development of safer and more effective medicines. HESI works to address complex challenges by leveraging diverse subject-matter expertise across sectors offering access to resources, data and shared knowledge. In 2008, the HESI Cardiac Safety Committee (CSC) was established to improve public health by reducing unanticipated cardiovascular (CV)-related adverse effects from pharmaceuticals or chemicals. The committee continues to significantly impact the field of CV safety by bringing together experts from across sectors to address challenges of detecting and predicting adverse cardiac outcomes. Committee members have collaborated on the organization, management and publication of prospective studies, retrospective analyses, workshops, and symposia resulting in 38 peer reviewed manuscripts. Without this collaboration these manuscripts would not have been published. Through their work, the CSC is actively addressing challenges and opportunities in detecting potential cardiac failure modes using in vivo, in vitro and in silico models, with the aim of facilitating drug development and improving study design. By examining past successes and future prospects of the CSC, this manuscript sheds light on how the consortium's multifaceted approach not only addresses current challenges in detecting potential cardiac failure modes but also paves the way for enhanced drug development and study design methodologies. Further, exploring future opportunities and challenges will focus on improving the translational predictability of nonclinical evaluations and reducing reliance on animal research in CV safety assessments.

摘要

健康与环境科学协会(HESI)是一个非营利组织,通过在学术界、监管机构和私营部门之间开展合作科学努力,致力于解决全球健康挑战。非临床学科的合作科学为加速开发更安全、更有效的药物提供了重要基石。HESI 通过利用跨部门的多元化专业知识来解决复杂的挑战,从而获得资源、数据和共享知识。2008 年,成立了 HESI 心脏安全委员会(CSC),通过减少药物或化学品的意外心血管(CV)相关不良影响来改善公共健康。该委员会通过汇集来自各个领域的专家来解决检测和预测不良心脏结果的挑战,继续对 CV 安全领域产生重大影响。委员会成员合作组织、管理和发表前瞻性研究、回顾性分析、研讨会和专题讨论会,共发表了 38 篇同行评审论文。没有这种合作,这些论文就不会发表。通过他们的工作,CSC 正在积极使用体内、体外和计算模型来检测潜在的心脏衰竭模式,以促进药物开发并改进研究设计,从而应对检测潜在心脏衰竭模式的挑战和机遇。通过检查 CSC 的过去成功和未来前景,本文阐明了该联盟的多方面方法不仅解决了当前检测潜在心脏衰竭模式的挑战,而且为增强药物开发和研究设计方法铺平了道路。此外,探索未来的机遇和挑战将侧重于提高非临床评估的转化预测能力,并减少对 CV 安全评估中动物研究的依赖。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a3c7/11318526/89733dc9ab08/nihms-1996448-f0001.jpg

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