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Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

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Název: Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics
Autoři: J. Javier Hernandez, Michael Pryszlak, Lindsay Smith, Connor Yanchus, Naheed Kurji, Vijay M. Shahani, Steven V. Molinski
Zdroj: Frontiers in Oncology, Vol 7 (2017)
Informace o vydavateli: Frontiers Media S.A., 2017.
Rok vydání: 2017
Sbírka: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Témata: drug repurposing, funding opportunities, in silico predictions, in vitro validation, intellectual property laws, oncology indications, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Popis: 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.
Druh dokumentu: article
Popis souboru: electronic resource
Jazyk: English
ISSN: 2234-943X
Relation: http://journal.frontiersin.org/article/10.3389/fonc.2017.00273/full; https://doaj.org/toc/2234-943X
DOI: 10.3389/fonc.2017.00273
Přístupová URL adresa: https://doaj.org/article/d0fd9d77c9ce4c72a6ca6c16b6a7145f
Přístupové číslo: edsdoj.0fd9d77c9ce4c72a6ca6c16b6a7145f
Databáze: Directory of Open Access Journals
Popis
Abstrakt: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.
ISSN:2234943X
DOI:10.3389/fonc.2017.00273