Reference number : GC-2017-Q3-00572, amendment number : , agreement type : G, recipient legal name : Ingalls, Brian (University of Waterloo), recipient country : CA, recipient province : nan, recipient city : Ontario, recipient postal code : nan, program name english : Engage Grants for universities, program name french : Subventions d'engagement partenarial pour les universités, program purpose english : Subsequent entry pharmaceutical (also known as off-patent or generic) drug manufacturing can provide_x000D_
significant savings to patients and healthcare systems. To enter the market, a subsequent entry pharmaceutical_x000D_
drug must be demonstrated to be as therapeutically effective as the original patented version. Demonstrations_x000D_
of equivalence are relatively straightforward for most traditional small-molecule drugs, as molecular replicas of_x000D_
the original can be readily generated by chemical synthesis. In contrast, demonstration of equivalence of the_x000D_
new class of biologic drugs (such as therapeutic antibodies) is not possible because these drugs are produced_x000D_
from diverse biological sources (such as living cells) which results in considerable variability in their structure_x000D_
(and hence chemistry) during manufacturing, even between production batches. As a consequence, subsequent_x000D_
entry biologics cannot be compared to the original patented biologic solely on the basis of structural and_x000D_
chemical features; and are therefore, often referred to as biosimilars rather than generics. The Canadian_x000D_
pharmaceutical company Apobiologix (Division of ApoPharma USA, Inc; a member of the Apotex Group of_x000D_
Companies) is exploring new approaches for verifying the similarity of its new subsequent entry biosimilar to_x000D_
a an the clinically approved breast-cancer biologic known as trastuzamab (marketed as Herceptin). They are_x000D_
seeking to characterize cellular responses of trastuzumab and their biosimilar to identify similarities and_x000D_
differences in drug action. As part of that characterization, the proposed research involves development of a_x000D_
computational modelling framework to interpret data from experiments comparingthe effects of these drugs on_x000D_
biochemical response networks in breast cancer cells. Insights from these modeling analyses are expected to_x000D_
reduce the time for development efforts of Apobiologix's trastuzamab biosimilar to reach the market, bringing_x000D_
cost-savings to breast cancer patients and healthcare systems earlier rather than later., program purpose french : Subsequent entry pharmaceutical (also known as off-patent or generic) drug manufacturing can provide_x000D_
significant savings to patients and healthcare systems. To enter the market, a subsequent entry pharmaceutical_x000D_
drug must be demonstrated to be as therapeutically effective as the original patented version. Demonstrations_x000D_
of equivalence are relatively straightforward for most traditional small-molecule drugs, as molecular replicas of_x000D_
the original can be readily generated by chemical synthesis. In contrast, demonstration of equivalence of the_x000D_
new class of biologic drugs (such as therapeutic antibodies) is not possible because these drugs are produced_x000D_
from diverse biological sources (such as living cells) which results in considerable variability in their structure_x000D_
(and hence chemistry) during manufacturing, even between production batches. As a consequence, subsequent_x000D_
entry biologics cannot be compared to the original patented biologic solely on the basis of structural and_x000D_
chemical features; and are therefore, often referred to as biosimilars rather than generics. The Canadian_x000D_
pharmaceutical company Apobiologix (Division of ApoPharma USA, Inc; a member of the Apotex Group of_x000D_
Companies) is exploring new approaches for verifying the similarity of its new subsequent entry biosimilar to_x000D_
a an the clinically approved breast-cancer biologic known as trastuzamab (marketed as Herceptin). They are_x000D_
seeking to characterize cellular responses of trastuzumab and their biosimilar to identify similarities and_x000D_
differences in drug action. As part of that characterization, the proposed research involves development of a_x000D_
computational modelling framework to interpret data from experiments comparingthe effects of these drugs on_x000D_
biochemical response networks in breast cancer cells. Insights from these modeling analyses are expected to_x000D_
reduce the time for development efforts of Apobiologix's trastuzamab biosimilar to reach the market, bringing_x000D_
cost-savings to breast cancer patients and healthcare systems earlier rather than later., agreement title english : Development of mathematical modelling tools for comparison of biosimilars, agreement title french : Development of mathematical modelling tools for comparison of biosimilars, agreement number : EGP, agreement value : 25000.0, agreement start date : 2017-10-18, agreement end date : nan, description english : nan, description french : nan, expected results english : nan, expected results french : nan, additional information english : Grant or Award spanning more than one fiscal year (2017-2018 to 2018-2019)., additional information french : Subvention ou bourse octroyée s'appliquant à plus d'un exercice financier (2017-2018 à 2018-2019)., owner organization : nserc-crsng, owner organization title : Natural Sciences and Engineering Research Council of Canada | Conseil de recherches en sciences naturelles et en génie du Canada