Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers

Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all relevant stakeholders to navigate. In this revie...

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Autores principales:	Tingting Qiu, Shuyao Liang, Yitong Wang, Claude Dussart, Borislav Borissov, Mondher Toumi
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	public-private partnership market authorization health technology assessment collaborations advanced therapy medicinal products (ATMPs) Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/3953a47776f74b8ea9eba7e8b0c68ba7
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spelling	oai:doaj.org-article:3953a47776f74b8ea9eba7e8b0c68ba72021-12-01T00:49:36ZReinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers2296-256510.3389/fpubh.2021.754482https://doaj.org/article/3953a47776f74b8ea9eba7e8b0c68ba72021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fpubh.2021.754482/fullhttps://doaj.org/toc/2296-2565Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all relevant stakeholders to navigate. In this review, we will elaborate on the importance of collaborations and harmonization across different stakeholders, to expedite the market access of promising ATMPs. Manufacturers of ATMPs should proactively establish collaborations with other stakeholders throughout the whole lifecycle of ATMPs, from early research to post-market activities. This covered engagements with (1) external developers (i.e., not-for-profit organizations and commercial players) to obtain complementary knowledge, technology, or infrastructures, (2) patient groups and healthcare providers to highlight their roles as active contributors, and (3) decision-makers, such as regulators, health technology assessment (HTA) agencies, and payers, to communicate the uncertainties in evidence package, where parallel consultation will be a powerful strategy. Harmonization between decision-makers is desired at (1) regulatory level, in terms of strengthening the international standardization of regulatory framework to minimize discrepancies in evidence requirements for market authorization, and (2) HTA level, in terms of enhancing alignments between regional and national HTA agencies to narrow inequity in patient access, and cross-border HTA cooperation to improve the quality and efficiency of HTA process. In conclusion, manufacturers and decision-makers shared the common goals to safeguard timely patient access to ATMPs. Collaboration and harmonization will be increasingly leveraged to enable the value delivery of ATMPs to all stakeholders.Tingting QiuShuyao LiangYitong WangClaude DussartBorislav BorissovMondher ToumiFrontiers Media S.A.articlepublic-private partnershipmarket authorizationhealth technology assessmentcollaborationsadvanced therapy medicinal products (ATMPs)Public aspects of medicineRA1-1270ENFrontiers in Public Health, Vol 9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	public-private partnership market authorization health technology assessment collaborations advanced therapy medicinal products (ATMPs) Public aspects of medicine RA1-1270
spellingShingle	public-private partnership market authorization health technology assessment collaborations advanced therapy medicinal products (ATMPs) Public aspects of medicine RA1-1270 Tingting Qiu Shuyao Liang Yitong Wang Claude Dussart Borislav Borissov Mondher Toumi Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
description	Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all relevant stakeholders to navigate. In this review, we will elaborate on the importance of collaborations and harmonization across different stakeholders, to expedite the market access of promising ATMPs. Manufacturers of ATMPs should proactively establish collaborations with other stakeholders throughout the whole lifecycle of ATMPs, from early research to post-market activities. This covered engagements with (1) external developers (i.e., not-for-profit organizations and commercial players) to obtain complementary knowledge, technology, or infrastructures, (2) patient groups and healthcare providers to highlight their roles as active contributors, and (3) decision-makers, such as regulators, health technology assessment (HTA) agencies, and payers, to communicate the uncertainties in evidence package, where parallel consultation will be a powerful strategy. Harmonization between decision-makers is desired at (1) regulatory level, in terms of strengthening the international standardization of regulatory framework to minimize discrepancies in evidence requirements for market authorization, and (2) HTA level, in terms of enhancing alignments between regional and national HTA agencies to narrow inequity in patient access, and cross-border HTA cooperation to improve the quality and efficiency of HTA process. In conclusion, manufacturers and decision-makers shared the common goals to safeguard timely patient access to ATMPs. Collaboration and harmonization will be increasingly leveraged to enable the value delivery of ATMPs to all stakeholders.
format	article
author	Tingting Qiu Shuyao Liang Yitong Wang Claude Dussart Borislav Borissov Mondher Toumi
author_facet	Tingting Qiu Shuyao Liang Yitong Wang Claude Dussart Borislav Borissov Mondher Toumi
author_sort	Tingting Qiu
title	Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
title_short	Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
title_full	Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
title_fullStr	Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
title_full_unstemmed	Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers
title_sort	reinforcing collaboration and harmonization to unlock the potentials of advanced therapy medical products: future efforts are awaited from manufacturers and decision-makers
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/3953a47776f74b8ea9eba7e8b0c68ba7
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Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers

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