Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly prov...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Cambridge University Press
2023-01-01
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| Series: | Antimicrobial Stewardship & Healthcare Epidemiology |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2732494X23001948/type/journal_article |
| _version_ | 1797792462673018880 |
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| author | Ofole Mgbako Justin Chan Robert A. Pitts Madeline A. DiLorenzo Dorothy Knutsen Dana Mazo |
| author_facet | Ofole Mgbako Justin Chan Robert A. Pitts Madeline A. DiLorenzo Dorothy Knutsen Dana Mazo |
| author_sort | Ofole Mgbako |
| collection | DOAJ |
| description | During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly provide tecovirimat to patients. |
| first_indexed | 2024-03-13T02:34:32Z |
| format | Article |
| id | doaj.art-b0a9d71ddc0640668612838d19a929aa |
| institution | Directory Open Access Journal |
| issn | 2732-494X |
| language | English |
| last_indexed | 2024-03-13T02:34:32Z |
| publishDate | 2023-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Antimicrobial Stewardship & Healthcare Epidemiology |
| spelling | doaj.art-b0a9d71ddc0640668612838d19a929aa2023-06-29T09:17:45ZengCambridge University PressAntimicrobial Stewardship & Healthcare Epidemiology2732-494X2023-01-01310.1017/ash.2023.194Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreakOfole Mgbako0https://orcid.org/0000-0002-8955-4303Justin Chan1Robert A. Pitts2Madeline A. DiLorenzo3https://orcid.org/0000-0003-1284-6428Dorothy Knutsen4Dana Mazo5Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USADivision of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USADivision of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USADivision of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USADivision of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USADivision of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USADuring the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly provide tecovirimat to patients.https://www.cambridge.org/core/product/identifier/S2732494X23001948/type/journal_article |
| spellingShingle | Ofole Mgbako Justin Chan Robert A. Pitts Madeline A. DiLorenzo Dorothy Knutsen Dana Mazo Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak Antimicrobial Stewardship & Healthcare Epidemiology |
| title | Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak |
| title_full | Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak |
| title_fullStr | Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak |
| title_full_unstemmed | Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak |
| title_short | Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak |
| title_sort | navigating the expanded access investigational new drug protocol for tecovirimat lessons learned from a public private hospital partnership during the 2022 nyc mpox outbreak |
| url | https://www.cambridge.org/core/product/identifier/S2732494X23001948/type/journal_article |
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