PDF(Pubmed)
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：
健康与环境科学研究所（HESI）是一个非营利性组织，致力于通过学术界的合作科学努力解决全球健康挑战。监管机构和私营部门。跨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的基石。HESI致力于通过利用各个部门的不同主题专业知识来解决复杂的挑战，从而提供对资源的访问，数据和共享知识。2008年，HESI心脏安全技术委员会（CSTC）成立，旨在通过减少药品或化学品引起的意外心血管（CV）相关不良反应来改善公众健康。该委员会通过汇集来自各个部门的专家来解决检测和预测不良心脏结果的挑战，继续对CV安全性领域产生重大影响。委员会成员在该组织上进行了合作，前瞻性研究的管理和出版，回顾性分析，工作坊,和专题讨论会产生38份同行评审的手稿。没有这种合作，这些手稿就不会出版。通过他们的工作,CSTC正在积极应对体内检测潜在心力衰竭模式的挑战和机遇，体外和计算机模型，目的是促进药物开发和改进研究设计。通过研究CSTC的过去成功和未来前景，该手稿阐明了该联盟的多面性方法不仅解决了当前在检测潜在心力衰竭模式方面的挑战,而且为增强药物开发和研究设计方法铺平了道路.Further,探索未来的机遇和挑战将集中在提高非临床评估的转化可预测性和减少CV安全性评估中对动物研究的依赖.
