Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics
The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restricti...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2017-11-01
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| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | http://journal.frontiersin.org/article/10.3389/fonc.2017.00273/full |
| _version_ | 1811325796597366784 |
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| author | J. Javier Hernandez J. Javier Hernandez Michael Pryszlak Michael Pryszlak Lindsay Smith Lindsay Smith Connor Yanchus Connor Yanchus Naheed Kurji Vijay M. Shahani Steven V. Molinski |
| author_facet | J. Javier Hernandez J. Javier Hernandez Michael Pryszlak Michael Pryszlak Lindsay Smith Lindsay Smith Connor Yanchus Connor Yanchus Naheed Kurji Vijay M. Shahani Steven V. Molinski |
| author_sort | J. Javier Hernandez |
| collection | DOAJ |
| description | The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike. |
| first_indexed | 2024-04-13T14:39:59Z |
| format | Article |
| id | doaj.art-d0fd9d77c9ce4c72a6ca6c16b6a7145f |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-13T14:39:59Z |
| publishDate | 2017-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-d0fd9d77c9ce4c72a6ca6c16b6a7145f2022-12-22T02:42:56ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2017-11-01710.3389/fonc.2017.00273291479Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer TherapeuticsJ. Javier Hernandez0J. Javier Hernandez1Michael Pryszlak2Michael Pryszlak3Lindsay Smith4Lindsay Smith5Connor Yanchus6Connor Yanchus7Naheed Kurji8Vijay M. Shahani9Steven V. Molinski10Department of Molecular Genetics, Faculty of Medicine, University of Toronto, Toronto, ON, CanadaLunenfeld-Tanenbaum Research Institute, Toronto, ON, CanadaDepartment of Molecular Genetics, Faculty of Medicine, University of Toronto, Toronto, ON, CanadaThe Hospital for Sick Children, Toronto, ON, CanadaDepartment of Molecular Genetics, Faculty of Medicine, University of Toronto, Toronto, ON, CanadaThe Hospital for Sick Children, Toronto, ON, CanadaDepartment of Molecular Genetics, Faculty of Medicine, University of Toronto, Toronto, ON, CanadaLunenfeld-Tanenbaum Research Institute, Toronto, ON, CanadaCyclica Inc., Toronto, ON, CanadaCyclica Inc., Toronto, ON, CanadaCyclica Inc., Toronto, ON, CanadaThe repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.http://journal.frontiersin.org/article/10.3389/fonc.2017.00273/fulldrug repurposingfunding opportunitiesin silico predictionsin vitro validationintellectual property lawsoncology indications |
| spellingShingle | J. Javier Hernandez J. Javier Hernandez Michael Pryszlak Michael Pryszlak Lindsay Smith Lindsay Smith Connor Yanchus Connor Yanchus Naheed Kurji Vijay M. Shahani Steven V. Molinski Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics Frontiers in Oncology drug repurposing funding opportunities in silico predictions in vitro validation intellectual property laws oncology indications |
| title | Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics |
| title_full | Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics |
| title_fullStr | Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics |
| title_full_unstemmed | Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics |
| title_short | Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics |
| title_sort | giving drugs a second chance overcoming regulatory and financial hurdles in repurposing approved drugs as cancer therapeutics |
| topic | drug repurposing funding opportunities in silico predictions in vitro validation intellectual property laws oncology indications |
| url | http://journal.frontiersin.org/article/10.3389/fonc.2017.00273/full |
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