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Clinical Development of Gene Therapies: The First Three Decades and Counting
In the past three decades the field of gene therapy has made remarkable progress, surging from mere laboratory experiments to Food and Drug Administration (FDA)-approved products that bring significant reduction in disease burden to patients who previously had no therapeutic options for their seriou...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society of Gene & Cell Therapy
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658574/ https://www.ncbi.nlm.nih.gov/pubmed/33209964 http://dx.doi.org/10.1016/j.omtm.2020.10.004 |
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author | Lapteva, Larissa Purohit-Sheth, Tejashri Serabian, Mercedes Puri, Raj K. |
author_facet | Lapteva, Larissa Purohit-Sheth, Tejashri Serabian, Mercedes Puri, Raj K. |
author_sort | Lapteva, Larissa |
collection | PubMed |
description | In the past three decades the field of gene therapy has made remarkable progress, surging from mere laboratory experiments to Food and Drug Administration (FDA)-approved products that bring significant reduction in disease burden to patients who previously had no therapeutic options for their serious conditions. Herein, we review the evolution of the gene therapy clinical research landscape and describe the gene therapy product development programs evaluated by the FDA in Investigational New Drug applications received in 1988–2019. We also discuss the clinical development programs of the first six oncolytic and gene therapy products approved in the United States. |
format | Online Article Text |
id | pubmed-7658574 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | American Society of Gene & Cell Therapy |
record_format | MEDLINE/PubMed |
spelling | pubmed-76585742020-11-17 Clinical Development of Gene Therapies: The First Three Decades and Counting Lapteva, Larissa Purohit-Sheth, Tejashri Serabian, Mercedes Puri, Raj K. Mol Ther Methods Clin Dev Review In the past three decades the field of gene therapy has made remarkable progress, surging from mere laboratory experiments to Food and Drug Administration (FDA)-approved products that bring significant reduction in disease burden to patients who previously had no therapeutic options for their serious conditions. Herein, we review the evolution of the gene therapy clinical research landscape and describe the gene therapy product development programs evaluated by the FDA in Investigational New Drug applications received in 1988–2019. We also discuss the clinical development programs of the first six oncolytic and gene therapy products approved in the United States. American Society of Gene & Cell Therapy 2020-10-10 /pmc/articles/PMC7658574/ /pubmed/33209964 http://dx.doi.org/10.1016/j.omtm.2020.10.004 Text en http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Review Lapteva, Larissa Purohit-Sheth, Tejashri Serabian, Mercedes Puri, Raj K. Clinical Development of Gene Therapies: The First Three Decades and Counting |
title | Clinical Development of Gene Therapies: The First Three Decades and Counting |
title_full | Clinical Development of Gene Therapies: The First Three Decades and Counting |
title_fullStr | Clinical Development of Gene Therapies: The First Three Decades and Counting |
title_full_unstemmed | Clinical Development of Gene Therapies: The First Three Decades and Counting |
title_short | Clinical Development of Gene Therapies: The First Three Decades and Counting |
title_sort | clinical development of gene therapies: the first three decades and counting |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658574/ https://www.ncbi.nlm.nih.gov/pubmed/33209964 http://dx.doi.org/10.1016/j.omtm.2020.10.004 |
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