Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

Delphine Ammar; Carmen Sanges; David Henderson; Inga Schapitz; Michael Hudecek; Maik Luu; Martina Schüssler-Lenz; Christian Buchholz; Paul Franz; Kristin Reiche; Ulrike Köhl; Norbert Ifrah; Bruno Quesnel; Maria Thermeli; Marie Jose Kersten; Franco Locatelli; Maria Luisa D'Amore; Chiara Bonini; Monica Casucci; Ulrike Philippar; Robin Doeswijk; Frederick Thielen; Carin Uyl - de Groot; Judith Theelen; Bernd Schröder; Andreas Kremer; Maria Quaranta; Felipe Prosper; Jan Van den Brulle; Ulf Grawunder; Emmanuel Donnadieu; Anne GALY; Christophe Ferrand; Nina Worel; Dirk Busch; Javier Briones; Leopold Sellner; Jurgen Kuball; Anna Sureda; Jacquelyn Awigena-Cook

doi:10.1016/j.jcyt.2025.09.007

Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

Delphine Ammar, Carmen Sanges^*, David Henderson, Inga Schapitz, Michael Hudecek, Maik Luu, Martina Schüssler-Lenz, Christian Buchholz, Paul Franz, Kristin Reiche, Ulrike Köhl, Norbert Ifrah, Bruno Quesnel, Maria Thermeli, Marie Jose Kersten, Franco Locatelli, Maria Luisa D'Amore, Chiara Bonini, Monica Casucci, Ulrike PhilipparRobin Doeswijk, Frederick Thielen, Carin Uyl - de Groot, Judith Theelen, Bernd Schröder, Andreas Kremer, Maria Quaranta, Felipe Prosper, Jan Van den Brulle, Ulf Grawunder, Emmanuel Donnadieu, Anne GALY, Christophe Ferrand, Nina Worel, Dirk Busch, Javier Briones, Leopold Sellner, Jurgen Kuball, Anna Sureda, Jacquelyn Awigena-Cook^*

^*Corresponding author for this work

Health Technology Assessment (HTA)

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

Abstract

With the proposal for major reform of the pharmaceutical legislation (Regulation (EU) 2023/0131, Directive (EU) 2023/0132) in April 2023, the foundations of Europe's regulatory architecture are being reshaped. The revised legislation proposes the removal of specialized committee functions (e.g., Committee for Advanced Therapies—CAT) by integrating their remit into other regulatory bodies, such as the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) and expert working groups. This decision may further challenge innovation in Europe, particularly in the field of advanced therapy medicinal products (ATMPs), which has already experienced a notable decline in global clinical trial activity over the past decade. This article emphasizes the importance of involving multistakeholder consortia such as T2EVOLVE in shaping pharmaceutical legislation to prevent the loss of specialized knowledge and the need for robust mechanisms that preserve developers’ access to ATMP regulatory expertise.

Original language	English
Article number	101984
Journal	Cytotherapy
DOIs	https://doi.org/10.1016/j.jcyt.2025.09.007
Publication status	E-pub ahead of print - 25 Sept 2025

Bibliographical note

Publisher Copyright:
© 2025 International Society for Cell & Gene Therapy

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Cite this

Ammar, D., Sanges, C., Henderson, D., Schapitz, I., Hudecek, M., Luu, M., Schüssler-Lenz, M., Buchholz, C., Franz, P., Reiche, K., Köhl, U., Ifrah, N., Quesnel, B., Thermeli, M., Kersten, M. J., Locatelli, F., D'Amore, M. L., Bonini, C., Casucci, M., ... Awigena-Cook, J. (2025). Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe. Cytotherapy, Article 101984. Advance online publication. https://doi.org/10.1016/j.jcyt.2025.09.007

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title = "Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe",

abstract = "With the proposal for major reform of the pharmaceutical legislation (Regulation (EU) 2023/0131, Directive (EU) 2023/0132) in April 2023, the foundations of Europe's regulatory architecture are being reshaped. The revised legislation proposes the removal of specialized committee functions (e.g., Committee for Advanced Therapies—CAT) by integrating their remit into other regulatory bodies, such as the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) and expert working groups. This decision may further challenge innovation in Europe, particularly in the field of advanced therapy medicinal products (ATMPs), which has already experienced a notable decline in global clinical trial activity over the past decade. This article emphasizes the importance of involving multistakeholder consortia such as T2EVOLVE in shaping pharmaceutical legislation to prevent the loss of specialized knowledge and the need for robust mechanisms that preserve developers{\textquoteright} access to ATMP regulatory expertise.",

author = "Delphine Ammar and Carmen Sanges and David Henderson and Inga Schapitz and Michael Hudecek and Maik Luu and Martina Sch{\"u}ssler-Lenz and Christian Buchholz and Paul Franz and Kristin Reiche and Ulrike K{\"o}hl and Norbert Ifrah and Bruno Quesnel and Maria Thermeli and Kersten, \{Marie Jose\} and Franco Locatelli and D'Amore, \{Maria Luisa\} and Chiara Bonini and Monica Casucci and Ulrike Philippar and Robin Doeswijk and Frederick Thielen and \{Uyl - de Groot\}, Carin and Judith Theelen and Bernd Schr{\"o}der and Andreas Kremer and Maria Quaranta and Felipe Prosper and \{Van den Brulle\}, Jan and Ulf Grawunder and Emmanuel Donnadieu and Anne GALY and Christophe Ferrand and Nina Worel and Dirk Busch and Javier Briones and Leopold Sellner and Jurgen Kuball and Anna Sureda and Jacquelyn Awigena-Cook",

note = "Publisher Copyright: {\textcopyright} 2025 International Society for Cell \& Gene Therapy",

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doi = "10.1016/j.jcyt.2025.09.007",

language = "English",

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Ammar, D, Sanges, C, Henderson, D, Schapitz, I, Hudecek, M, Luu, M, Schüssler-Lenz, M, Buchholz, C, Franz, P, Reiche, K, Köhl, U, Ifrah, N, Quesnel, B, Thermeli, M, Kersten, MJ, Locatelli, F, D'Amore, ML, Bonini, C, Casucci, M, Philippar, U, Doeswijk, R, Thielen, F , Uyl - de Groot, C, Theelen, J, Schröder, B, Kremer, A, Quaranta, M, Prosper, F, Van den Brulle, J, Grawunder, U, Donnadieu, E, GALY, A, Ferrand, C, Worel, N, Busch, D, Briones, J, Sellner, L, Kuball, J, Sureda, A & Awigena-Cook, J 2025, 'Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe', Cytotherapy. https://doi.org/10.1016/j.jcyt.2025.09.007

TY - JOUR

T1 - Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

AU - Ammar, Delphine

AU - Sanges, Carmen

AU - Henderson, David

AU - Schapitz, Inga

AU - Hudecek, Michael

AU - Luu, Maik

AU - Schüssler-Lenz, Martina

AU - Buchholz, Christian

AU - Franz, Paul

AU - Reiche, Kristin

AU - Köhl, Ulrike

AU - Ifrah, Norbert

AU - Quesnel, Bruno

AU - Thermeli, Maria

AU - Kersten, Marie Jose

AU - Locatelli, Franco

AU - D'Amore, Maria Luisa

AU - Bonini, Chiara

AU - Casucci, Monica

AU - Philippar, Ulrike

AU - Doeswijk, Robin

AU - Thielen, Frederick

AU - Uyl - de Groot, Carin

AU - Theelen, Judith

AU - Schröder, Bernd

AU - Kremer, Andreas

AU - Quaranta, Maria

AU - Prosper, Felipe

AU - Van den Brulle, Jan

AU - Grawunder, Ulf

AU - Donnadieu, Emmanuel

AU - GALY, Anne

AU - Ferrand, Christophe

AU - Worel, Nina

AU - Busch, Dirk

AU - Briones, Javier

AU - Sellner, Leopold

AU - Kuball, Jurgen

AU - Sureda, Anna

AU - Awigena-Cook, Jacquelyn

PY - 2025/9/25

Y1 - 2025/9/25

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AB - With the proposal for major reform of the pharmaceutical legislation (Regulation (EU) 2023/0131, Directive (EU) 2023/0132) in April 2023, the foundations of Europe's regulatory architecture are being reshaped. The revised legislation proposes the removal of specialized committee functions (e.g., Committee for Advanced Therapies—CAT) by integrating their remit into other regulatory bodies, such as the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) and expert working groups. This decision may further challenge innovation in Europe, particularly in the field of advanced therapy medicinal products (ATMPs), which has already experienced a notable decline in global clinical trial activity over the past decade. This article emphasizes the importance of involving multistakeholder consortia such as T2EVOLVE in shaping pharmaceutical legislation to prevent the loss of specialized knowledge and the need for robust mechanisms that preserve developers’ access to ATMP regulatory expertise.

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DO - 10.1016/j.jcyt.2025.09.007

M3 - Article

C2 - 41217312

AN - SCOPUS:105021526332

SN - 1465-3249

JO - Cytotherapy

JF - Cytotherapy

M1 - 101984

ER -

Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

Abstract

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