The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy

Abstract The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services’ National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cel...

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Autores principales:	Ashraf El Fiky, Laarni Ibenana, Robert Anderson, Joshua M. Hare, Aisha Khan, Adrian P. Gee, Cliona Rooney, David H. McKenna, Joseph Gold, Linda Kelley, Martha S. Lundberg, Lisbeth A. Welniak, Robert Lindblad
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/ff938c54c87c45968ca22d3530c8d620
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spelling	oai:doaj.org-article:ff938c54c87c45968ca22d3530c8d6202021-11-19T17:51:34ZThe National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy1752-80621752-805410.1111/cts.13102https://doaj.org/article/ff938c54c87c45968ca22d3530c8d6202021-11-01T00:00:00Zhttps://doi.org/10.1111/cts.13102https://doaj.org/toc/1752-8054https://doaj.org/toc/1752-8062Abstract The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services’ National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cell therapeutics in the areas of heart, lung, and blood diseases. The program began in 2003, continued under two competitive renewals, and ended June 2021. PACT has supported cell therapy product manufacturing, investigational new drug enabling preclinical studies, and translational services, and has provided regulatory assistance for candidate cell therapy products that may aid in the repair and regeneration of damaged/diseased cells, tissues, and organs. PACT currently supports the development of novel cell therapies through five cell processing facilities. These facilities offer manufacturing processes, analytical development, technology transfer, process scale‐up, and preclinical development expertise necessary to produce cell therapy products that are compliant with Good Laboratory Practices, current Good Manufacturing Practices, and current Good Tissue Practices regulations. The Emmes Company, LLC, serves as the Coordinating Center and assists with the management and coordination of PACT and its application submission and review process. This paper discusses the impact and accomplishments of the PACT program on the cell therapy field and its evolution over the duration of the program. It highlights the work that has been accomplished and provides a foundation to build future programs with similar goals to advance cellular therapeutics in a coordinated and centralized programmatic manner to support unmet medical needs within NHLBI purview.Ashraf El FikyLaarni IbenanaRobert AndersonJoshua M. HareAisha KhanAdrian P. GeeCliona RooneyDavid H. McKennaJoseph GoldLinda KelleyMartha S. LundbergLisbeth A. WelniakRobert LindbladWileyarticleTherapeutics. PharmacologyRM1-950Public aspects of medicineRA1-1270ENClinical and Translational Science, Vol 14, Iss 6, Pp 2099-2110 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
spellingShingle	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270 Ashraf El Fiky Laarni Ibenana Robert Anderson Joshua M. Hare Aisha Khan Adrian P. Gee Cliona Rooney David H. McKenna Joseph Gold Linda Kelley Martha S. Lundberg Lisbeth A. Welniak Robert Lindblad The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
description	Abstract The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services’ National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cell therapeutics in the areas of heart, lung, and blood diseases. The program began in 2003, continued under two competitive renewals, and ended June 2021. PACT has supported cell therapy product manufacturing, investigational new drug enabling preclinical studies, and translational services, and has provided regulatory assistance for candidate cell therapy products that may aid in the repair and regeneration of damaged/diseased cells, tissues, and organs. PACT currently supports the development of novel cell therapies through five cell processing facilities. These facilities offer manufacturing processes, analytical development, technology transfer, process scale‐up, and preclinical development expertise necessary to produce cell therapy products that are compliant with Good Laboratory Practices, current Good Manufacturing Practices, and current Good Tissue Practices regulations. The Emmes Company, LLC, serves as the Coordinating Center and assists with the management and coordination of PACT and its application submission and review process. This paper discusses the impact and accomplishments of the PACT program on the cell therapy field and its evolution over the duration of the program. It highlights the work that has been accomplished and provides a foundation to build future programs with similar goals to advance cellular therapeutics in a coordinated and centralized programmatic manner to support unmet medical needs within NHLBI purview.
format	article
author	Ashraf El Fiky Laarni Ibenana Robert Anderson Joshua M. Hare Aisha Khan Adrian P. Gee Cliona Rooney David H. McKenna Joseph Gold Linda Kelley Martha S. Lundberg Lisbeth A. Welniak Robert Lindblad
author_facet	Ashraf El Fiky Laarni Ibenana Robert Anderson Joshua M. Hare Aisha Khan Adrian P. Gee Cliona Rooney David H. McKenna Joseph Gold Linda Kelley Martha S. Lundberg Lisbeth A. Welniak Robert Lindblad
author_sort	Ashraf El Fiky
title	The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
title_short	The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
title_full	The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
title_fullStr	The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
title_full_unstemmed	The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
title_sort	national heart, lung, and blood institute‐funded production assistance for cellular therapies (pact) program: eighteen years of cell therapy
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/ff938c54c87c45968ca22d3530c8d620
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The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy

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