CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations

Christian Chabannon; Jessica Lemaitre; Régis Peffault de Latour; Bénédicte Neven; Jacques Olivier Bay; Marie Robin; Jurgen Kuball; Sofie Terwel; Mohamad Mohty; Ibrahim Yakoub-Agha

doi:10.1016/j.bulcan.2021.08.004

CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations

Translated title of the contribution: CAR-T CELLS: How does the EBMT registry monitor European activities, identify hurdles and prepare for changes in regulations

Christian Chabannon^*, Jessica Lemaitre, Régis Peffault de Latour, Bénédicte Neven, Jacques Olivier Bay, Marie Robin, Jurgen Kuball, Sofie Terwel, Mohamad Mohty, Ibrahim Yakoub-Agha

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.

Translated title of the contribution	CAR-T CELLS: How does the EBMT registry monitor European activities, identify hurdles and prepare for changes in regulations
Original language	French
Pages (from-to)	S155-S161
Number of pages	7
Journal	BULLETIN DU CANCER
Volume	108
Issue number	10
DOIs	https://doi.org/10.1016/j.bulcan.2021.08.004
Publication status	Published - Oct 2021

Keywords

CAR-T Cells
Immunotherapy
Leukamia
Lymphoma
Multiple myeloma
T-Lymphocytes/immunology
Europe
Humans
Immunotherapy, Adoptive/economics
Receptors, Chimeric Antigen/immunology
Data Collection/methods
Marketing
Registries/statistics & numerical data

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10.1016/j.bulcan.2021.08.004

Cite this

Chabannon, C., Lemaitre, J., Peffault de Latour, R., Neven, B., Bay, J. O., Robin, M., Kuball, J., Terwel, S., Mohty, M., & Yakoub-Agha, I. (2021). CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations. BULLETIN DU CANCER, 108(10), S155-S161. https://doi.org/10.1016/j.bulcan.2021.08.004

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title = "CAR-T cells: comment le registre de l'EBMT monitore les activit{\'e}s en Europe, identifie les contraintes et pr{\'e}pare l{\textquoteright}{\'e}volution des r{\'e}gulations",

abstract = "CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.",

keywords = "CAR-T Cells, Immunotherapy, Leukamia, Lymphoma, Multiple myeloma, T-Lymphocytes/immunology, Europe, Humans, Immunotherapy, Adoptive/economics, Receptors, Chimeric Antigen/immunology, Data Collection/methods, Marketing, Registries/statistics & numerical data",

author = "Christian Chabannon and Jessica Lemaitre and {Peffault de Latour}, R{\'e}gis and B{\'e}n{\'e}dicte Neven and Bay, {Jacques Olivier} and Marie Robin and Jurgen Kuball and Sofie Terwel and Mohamad Mohty and Ibrahim Yakoub-Agha",

note = "Funding Information: Les auteurs remercient l'ensemble des praticiens et data managers des centres francophones et europ{\'e}ens qui rapportent leurs donn{\'e}es {\`a} l'EBMT, l'ensemble des personnels de l'EBMT pour le d{\'e}ploiement et l'usage du registre CAR-T cells, et surtout l'ensemble des patients et familles qui consentent au transfert de leurs donn{\'e}es vers le registre de l'EBMT et {\`a} participer aux {\'e}tudes PASS. Publisher Copyright: {\textcopyright} 2021 Soci{\'e}t{\'e} Fran{\c c}aise du Cancer",

year = "2021",

month = oct,

doi = "10.1016/j.bulcan.2021.08.004",

language = "French",

volume = "108",

pages = "S155--S161",

journal = "BULLETIN DU CANCER",

issn = "0007-4551",

publisher = "John Libbey",

number = "10",

}

Chabannon, C, Lemaitre, J, Peffault de Latour, R, Neven, B, Bay, JO, Robin, M, Kuball, J, Terwel, S, Mohty, M & Yakoub-Agha, I 2021, 'CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations', BULLETIN DU CANCER, vol. 108, no. 10, pp. S155-S161. https://doi.org/10.1016/j.bulcan.2021.08.004

CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations. / Chabannon, Christian; Lemaitre, Jessica; Peffault de Latour, Régis et al.
In: BULLETIN DU CANCER, Vol. 108, No. 10, 10.2021, p. S155-S161.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - CAR-T cells

T2 - comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations

AU - Chabannon, Christian

AU - Lemaitre, Jessica

AU - Peffault de Latour, Régis

AU - Neven, Bénédicte

AU - Bay, Jacques Olivier

AU - Robin, Marie

AU - Kuball, Jurgen

AU - Terwel, Sofie

AU - Mohty, Mohamad

AU - Yakoub-Agha, Ibrahim

N1 - Funding Information: Les auteurs remercient l'ensemble des praticiens et data managers des centres francophones et européens qui rapportent leurs données à l'EBMT, l'ensemble des personnels de l'EBMT pour le déploiement et l'usage du registre CAR-T cells, et surtout l'ensemble des patients et familles qui consentent au transfert de leurs données vers le registre de l'EBMT et à participer aux études PASS. Publisher Copyright: © 2021 Société Française du Cancer

PY - 2021/10

Y1 - 2021/10

N2 - CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.

AB - CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.

KW - CAR-T Cells

KW - Immunotherapy

KW - Leukamia

KW - Lymphoma

KW - Multiple myeloma

KW - T-Lymphocytes/immunology

KW - Europe

KW - Humans

KW - Immunotherapy, Adoptive/economics

KW - Receptors, Chimeric Antigen/immunology

KW - Data Collection/methods

KW - Marketing

KW - Registries/statistics & numerical data

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DO - 10.1016/j.bulcan.2021.08.004

M3 - Article

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AN - SCOPUS:85121154229

SN - 0007-4551

VL - 108

SP - S155-S161

JO - BULLETIN DU CANCER

JF - BULLETIN DU CANCER

IS - 10

ER -

CAR-T cells: comment le registre de l'EBMT monitore les activités en Europe, identifie les contraintes et prépare l’évolution des régulations

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Keywords

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