Development of mathematical modelling tools for comparison of biosimilars

开发用于生物仿制药比较的数学建模工具

基本信息

  • 批准号:
    515369-2017
  • 负责人:
  • 金额:
    $ 1.82万
  • 依托单位:
  • 依托单位国家:
    加拿大
  • 项目类别:
    Engage Grants Program
  • 财政年份:
    2017
  • 资助国家:
    加拿大
  • 起止时间:
    2017-01-01 至 2018-12-31
  • 项目状态:
    已结题

项目摘要

Subsequent entry pharmaceutical (also known as off-patent or generic) drug manufacturing can providesignificant savings to patients and healthcare systems. To enter the market, a subsequent entry pharmaceuticaldrug must be demonstrated to be as therapeutically effective as the original patented version. Demonstrationsof equivalence are relatively straightforward for most traditional small-molecule drugs, as molecular replicas ofthe original can be readily generated by chemical synthesis. In contrast, demonstration of equivalence of thenew class of biologic drugs (such as therapeutic antibodies) is not possible because these drugs are producedfrom diverse biological sources (such as living cells) which results in considerable variability in their structure(and hence chemistry) during manufacturing, even between production batches. As a consequence, subsequententry biologics cannot be compared to the original patented biologic solely on the basis of structural andchemical features; and are therefore, often referred to as biosimilars rather than generics. The Canadianpharmaceutical company Apobiologix (Division of ApoPharma USA, Inc; a member of the Apotex Group ofCompanies) is exploring new approaches for verifying the similarity of its new subsequent entry biosimilar toa an the clinically approved breast-cancer biologic known as trastuzamab (marketed as Herceptin). They areseeking to characterize cellular responses of trastuzumab and their biosimilar to identify similarities anddifferences in drug action. As part of that characterization, the proposed research involves development of acomputational modelling framework to interpret data from experiments comparingthe effects of these drugs onbiochemical response networks in breast cancer cells. Insights from these modeling analyses are expected toreduce the time for development efforts of Apobiologix's trastuzamab biosimilar to reach the market, bringingcost-savings to breast cancer patients and healthcare systems earlier rather than later.
后续进入制药(也称为非专利或仿制药)药品生产可以为患者和医疗保健系统节省大量成本。为了进入市场,后续进入的药品必须被证明具有与原始专利版本一样的治疗效果。对于大多数传统小分子药物来说,等效性的证明相对简单,因为可以通过化学合成轻松生成原始小分子药物的分子复制品。相比之下,证明新型生物药物(例如治疗性抗体)的等效性是不可能的,因为这些药物是由不同的生物来源(例如活细胞)生产的,这导致其结构(以及化学成分)在制造过程中(甚至在生产批次之间)存在相当大的变异性。因此,后续进入的生物制剂不能仅根据结构和化学特征与原始专利生物制剂进行比较;因此,通常被称为生物仿制药而不是仿制药。加拿大制药公司 Apobiologix(ApoPharma USA, Inc 的分部;Apotex 集团公司的成员)正在探索新方法,以验证其新的后续进入生物仿制药与临床批准的乳腺癌生物制剂曲妥珠单抗(商品名赫赛汀)的相似性。他们正在寻求表征曲妥珠单抗及其生物仿制药的细胞反应,以确定药物作用的相似性和差异。作为该表征的一部分,拟议的研究涉及开发计算模型框架,以解释比较这些药物对乳腺癌细胞生化反应网络影响的实验数据。这些模型分析的见解预计将缩短 Apobiologix 的曲妥珠单抗生物仿制药上市的开发时间,尽早为乳腺癌患者和医疗保健系统节省成本。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Ingalls, Brian其他文献

Component Characterization in a Growth-Dependent Physiological Context: Optimal Experimental Design
  • DOI:
    10.3390/pr7010052
  • 发表时间:
    2019-01-01
  • 期刊:
  • 影响因子:
    3.5
  • 作者:
    Braniff, Nathan;Scott, Matthew;Ingalls, Brian
  • 通讯作者:
    Ingalls, Brian
Estimations of intrinsic and extrinsic noise in models of nonlinear genetic networks
  • DOI:
    10.1063/1.2211787
  • 发表时间:
    2006-06-01
  • 期刊:
  • 影响因子:
    2.9
  • 作者:
    Scott, Matthew;Ingalls, Brian;Kaern, Mads
  • 通讯作者:
    Kaern, Mads
Advancing undergraduate synthetic biology education: insights from a Canadian iGEM student perspective
  • DOI:
    10.1139/cjm-2020-0549
  • 发表时间:
    2021-10-01
  • 期刊:
  • 影响因子:
    2.8
  • 作者:
    Diep, Patrick;Boucinha, Austin;Ingalls, Brian
  • 通讯作者:
    Ingalls, Brian
NLoed: A Python Package for Nonlinear Optimal Experimental Design in Systems Biology.
  • DOI:
    10.1021/acssynbio.2c00131
  • 发表时间:
    2022-12-16
  • 期刊:
  • 影响因子:
    4.7
  • 作者:
    Braniff, Nathan;Pearce, Taylor;Lu, Zixuan;Astwood, Michael;Forrest, William S. R.;Receno, Cody;Ingalls, Brian
  • 通讯作者:
    Ingalls, Brian
Transient dynamic phenotypes as criteria for model discrimination: fold-change detection in Rhodobacter sphaeroides chemotaxis
  • DOI:
    10.1098/rsif.2012.0935
  • 发表时间:
    2013-03-06
  • 期刊:
  • 影响因子:
    3.9
  • 作者:
    Hamadeh, Abdullah;Ingalls, Brian;Sontag, Eduardo
  • 通讯作者:
    Sontag, Eduardo

Ingalls, Brian的其他文献

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{{ truncateString('Ingalls, Brian', 18)}}的其他基金

Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    RGPIN-2018-03826
  • 财政年份:
    2022
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    RGPIN-2018-03826
  • 财政年份:
    2021
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    RGPIN-2018-03826
  • 财政年份:
    2020
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    522660-2018
  • 财政年份:
    2019
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Accelerator Supplements
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    RGPIN-2018-03826
  • 财政年份:
    2019
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    522660-2018
  • 财政年份:
    2018
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Accelerator Supplements
Model-based design for synthetic (micro)biology
基于模型的合成(微)生物学设计
  • 批准号:
    RGPIN-2018-03826
  • 财政年份:
    2018
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Control-Theoretic Approaches in Systems Biology: sensitivity conservations as performance constraints
系统生物学中的控制理论方法:作为性能约束的灵敏度守恒
  • 批准号:
    261734-2012
  • 财政年份:
    2017
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Control-Theoretic Approaches in Systems Biology: sensitivity conservations as performance constraints
系统生物学中的控制理论方法:作为性能约束的灵敏度守恒
  • 批准号:
    261734-2012
  • 财政年份:
    2016
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual
Control-Theoretic Approaches in Systems Biology: sensitivity conservations as performance constraints
系统生物学中的控制理论方法:作为性能约束的灵敏度守恒
  • 批准号:
    261734-2012
  • 财政年份:
    2015
  • 资助金额:
    $ 1.82万
  • 项目类别:
    Discovery Grants Program - Individual

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