STTR Phase I: Developing a platform for superior predictive analysis of HERG Ion Channel-Drug Interactions for the Comprehensive In-vitro Proarrhythmia Assay (CiPA)

STTR 第一阶段:开发一个平台,对 HERG 离子通道-药物相互作用进行高级预测分析,用于综合体外致心律失常测定 (CiPA)

基本信息

  • 批准号:
    1913793
  • 负责人:
  • 金额:
    $ 22.5万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
    Standard Grant
  • 财政年份:
    2019
  • 资助国家:
    美国
  • 起止时间:
    2019-07-01 至 2021-09-30
  • 项目状态:
    已结题

项目摘要

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) project will be to improve the safety testing of new drugs for approval by the FDA. By decreasing the time and costs associated with safety testing, the product will make all classes of new drugs safer, less expensive and available to patients sooner. All new drugs must demonstrate that they are safe. One common and critical point at which new candidate treatments fail is because they have the serious side effect of promoting sudden cardiac death through lethal arrhythmias. This product combines advanced biological techniques with advanced computing to develop a system that will enable pharma and biotech companies to more rapidly and accurately identify pro-arrhythmic drugs earlier in the development process, thus saving drug companies significant costs associated with drug development. Drugs that ultimately fail cardiac safety screening need to be eliminated as soon as possible from the development pipeline, and certainly pre-clinically. A drug that makes it to clinical trials before cardiac side effects are identified can result in significant wasted costs, in addition to the human cost. Conversely, a drug incorrectly eliminated also can be costly, both in terms of lost revenue and benefit to society.This STTR Phase I is a proposal to improve the extraction of key data from experiments on the HERG ion channel and its interpretation through computational modeling in the new FDA CiPA initiative. Preclinical safety testing currently focuses on two interdependent questions: 1) Does the drug block the HERG channel? and 2) Does the drug prolong the action potential? The CiPA initiative proposes to integrate this process systematically, through screening of a defined set of cloned ion channels in high throughput systems and combing this with action potential modelling through the qNet index. The HERG channel is handled separately using a complex state-dependent block model that due to its complexity requires very difficult and time consuming manual measurements. This proposal will automate this process by using a real-time interface to computer model block and evaluate the information coming from voltage clamp experiments as they occur. As such it will be an artificial intelligence that will substitute for the judgement of a human experimenter by focusing only on protocols and exposure times that define the kinetics of a particular drug.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
该小企业技术转让 (STTR) 项目更广泛的影响/商业潜力将是改善 FDA 批准的新药的安全性测试。 通过减少与安全测试相关的时间和成本,该产品将使所有类别的新药更安全、更便宜并更快地提供给患者。 所有新药都必须证明它们是安全的。 新候选疗法失败的一个常见且关键的一点是,它们具有通过致命性心律失常促进心源性猝死的严重副作用。该产品将先进的生物技术与先进的计算相结合,开发出一种系统,使制药和生物技术公司能够在开发过程的早期更快速、更准确地识别促心律失常药物,从而为制药公司节省与药物开发相关的大量成本。最终未能通过心脏安全性筛选的药物需要尽快从开发渠道中淘汰,当然是在临床前淘汰。在确定心脏副作用之前进入临床试验的药物除了人力成本之外,还可能导致大量成本浪费。相反,错误消除的药物也可能代价高昂,无论是收入损失还是社会效益。STTR 第一阶段是一项提议,旨在改进从 HERG 离子通道实验中提取关键数据,并通过计算模型对其进行解释。 FDA 新的 CiPA 计划。临床前安全性测试目前主要关注两个相互依赖的问题:1)该药物是否会阻断 HERG 通道? 2) 该药物是否会延长动作电位? CiPA 倡议建议通过筛选高通量系统中一组定义的克隆离子通道,并通过 qNet 指数将其与动作电位建模相结合,系统地集成该过程。 HEG 通道使用复杂的状态相关模块模型单独处理,由于其复杂性,需要非常困难且耗时的手动测量。该提案将通过使用计算机模型块的实时接口来自动化该过程,并在电压钳实验发生时评估来自电压钳实验的信息。 因此,它将成为一种人工智能,通过仅关注定义特定药物动力学的方案和暴露时间来取代人类实验者的判断。该奖项反映了 NSF 的法定使命,并被认为值得通过评估获得支持利用基金会的智力优势和更广泛的影响审查标准。

项目成果

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Leigh Korbel其他文献

Leigh Korbel的其他文献

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{{ truncateString('Leigh Korbel', 18)}}的其他基金

SBIR Phase II: Developing a platform for superior predictive analysis of HERG Ion Channel-Drug Interactions for the Comprehensive In-vitro Proarrhythmia Assay (CiPA)
SBIR II 期:开发一个平台,对 HERG 离子通道-药物相互作用进行高级预测分析,用于综合体外致心律失常测定 (CiPA)
  • 批准号:
    2151522
  • 财政年份:
    2022
  • 资助金额:
    $ 22.5万
  • 项目类别:
    Cooperative Agreement

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