Bioinfogate与FDA达成合作,旨在提供关键的临床前毒性数据及临床不良事件情报

科睿唯安
生命科学与制药

这项协议旨在评估OFF-X作为药物及相关分子靶标安全性评估的新方法,帮助FDA履行保护公众健康的使命。

 

2019年5月21日,巴塞罗那

根据材料转让协议,FDA在整个机构范围内均可访问由Bioinfogate公司开发的转化安全情报数据库OFF-X™。本协议的主要目标是评估OFF-X作为研究工具的潜在用途,包括预测与分子靶标相关的不良事件及其在监管审评过程中的应用。根据最近的补充协议,FDA将持续对OFF-X数据库的实用性、功能和使用过程中的相关问题提供反馈。

预料之外的安全性事件历来都是临床研究中最棘手的问题之一。整合了临床前和临床研究安全性数据的解决方案可以显著减轻患者的负担并避免代价高昂的失败。基于上述考虑,在药物研发过程中尽早地识别与新靶标和药物相关的潜在安全性风险是十分必要的。

关于FDA药品评价与研究中心

FDA的药品评价与研究中心(CDER)履行着至关重要的公共健康任务,确保在美国提供安全有效的药物,改善人类健康。作为FDA的一部分,CDER监管着非处方药和处方药,包括生物制品和仿制药。CDER的使命是保护和促进公共健康,保证人用药品的安全性、有效性,并确保药品符合既定的质量标准和患者用药的可及性。

关于Bioinfogate的OFF-XTM

Bioinfogate是一家领先的数据科学公司,OFF-XTM是该公司开发的药物转化安全情报数据库(https://www.targetsafety.info/)。通过提供关键的临床前毒性数据和临床不良事件情报并加以整合与分析,OFF-X能够对药物研发的全阶段进行安全性监测。该数据库每天对药品安全警戒事件进行专业的编撰和更新,截至2019年6月,OFF-X已经收录了约7600种靶标和近10000种药物和生物制剂,包含超过31.5万个经过专业编撰的安全警戒事件,涉及5000余种不良反应。OFF-X覆盖了药物及其靶标研发的所有阶段,从新靶标的首次发现直至药品进入市场。OFF-X的目标是尽早识别毒理和安全性信号,降低项目的研发风险。

如需了解更多信息,请联系info@bioinfogate.com或访问www.bioinfogate.com

 

FDA and BIOINFOGATE agree to extend the material transfer agreement (MTA) to access the Off-X translational safety intelligence portal

The agreement aims to evaluate new approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets, supporting the FDAs mission of protecting public health.

Barcelona, May 21, 2019

Under this MTA, the FDA has agency-wide access to Bioinfogate’s translational safety intelligence portal, OFF-X. The primary objective of the agreement is to evaluate the potential use of Bioinfogate OFF-X™ as a research tool to anticipate adverse events associated with molecular targets and evaluate its utility in the regulatory review process. Under the recently extended agreement, the FDA will continue to provide feedback on the utility of the OFF-X database and/or any aspects related to its functioning and use.

Unexpected safety issues constitute one of the most disruptive events in clinical research. A translational approach to drug safety that integrates preclinical and clinical data can significantly reduce patient burden and avoid costly failures. In this context, it is essential to detect as early as possible in the drug R&D process the potential safety liabilities associated to both new targets and drugs under development.

About FDA CDER

FDA/CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. FDA/CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients.

About Bioinfogate OFF-XTM

Bioinfogate, a leading data science organization, is the producer of the OFF-X translational safety intelligence portal (https://www.targetsafety.info/). By delivering critical integrated preclinical toxicity and clinical adverse event intelligence coupled to advanced analytics, OFF-X allows safety liabilities to be monitored and anticipated across all phases of drug R&D. Updated daily with expertly curated safety alerts, as of June 2019, the portal covers a range of 7,600 targets, close to 10,000 drugs & biologics, and is populated with more than 315,000 expertly curated safety alerts associated to 5,000 adverse effects. OFF-X covers targets and drugs in all stages of drug R&D from emerging and first-in-class targets to drugs that have reached the market place. OFF-X aims to promptly identify toxicology and safety signals and de-risk R&D programs.

For more information please contact us at info@bioinfogate.com or visit www.bioinfogate.com

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