Subventions et des contributions :

Titre :
Development of mathematical modelling tools for comparison of biosimilars
Numéro de l’entente :
EGP
Valeur d'entente :
25 000,00 $
Date d'entente :
18 oct. 2017 -
Organisation :
Conseil de recherches en sciences naturelles et en génie du Canada
Location :
Ontario, Autre, CA
Numéro de référence :
GC-2017-Q3-00572
Type d'entente :
subvention
Type de rapport :
Subventions et des contributions
Renseignements supplémentaires :

Subvention ou bourse octroyée s'appliquant à plus d'un exercice financier (2017-2018 à 2018-2019).

Nom légal du bénéficiaire :
Ingalls, Brian (University of Waterloo)
Programme :
Subventions d'engagement partenarial pour les universités
But du programme :

Subsequent entry pharmaceutical (also known as off-patent or generic) drug manufacturing can providex000D
significant savings to patients and healthcare systems. To enter the market, a subsequent entry pharmaceuticalx000D
drug must be demonstrated to be as therapeutically effective as the original patented version. Demonstrationsx000D
of equivalence are relatively straightforward for most traditional small-molecule drugs, as molecular replicas ofx000D
the original can be readily generated by chemical synthesis. In contrast, demonstration of equivalence of thex000D
new class of biologic drugs (such as therapeutic antibodies) is not possible because these drugs are producedx000D
from diverse biological sources (such as living cells) which results in considerable variability in their structurex000D
(and hence chemistry) during manufacturing, even between production batches. As a consequence, subsequentx000D
entry biologics cannot be compared to the original patented biologic solely on the basis of structural andx000D
chemical features; and are therefore, often referred to as biosimilars rather than generics. The Canadianx000D
pharmaceutical company Apobiologix (Division of ApoPharma USA, Inc; a member of the Apotex Group ofx000D
Companies) is exploring new approaches for verifying the similarity of its new subsequent entry biosimilar tox000D
a an the clinically approved breast-cancer biologic known as trastuzamab (marketed as Herceptin). They arex000D
seeking to characterize cellular responses of trastuzumab and their biosimilar to identify similarities andx000D
differences in drug action. As part of that characterization, the proposed research involves development of ax000D
computational modelling framework to interpret data from experiments comparingthe effects of these drugs onx000D
biochemical response networks in breast cancer cells. Insights from these modeling analyses are expected tox000D
reduce the time for development efforts of Apobiologix's trastuzamab biosimilar to reach the market, bringingx000D
cost-savings to breast cancer patients and healthcare systems earlier rather than later.