El CRAI romandrà tancat del 24 de desembre de 2025 al 6 de gener de 2026. La validació de documents es reprendrà a partir del 7 de gener de 2026.
El CRAI permanecerá cerrado del 24 de diciembre de 2025 al 6 de enero de 2026. La validación de documentos se reanudará a partir del 7 de enero de 2026.
From 2025-12-24 to 2026-01-06, the CRAI remain closed and the documents will be validated from 2026-01-07.
 
Miniatura

Fitxers

874781.pdf (1.03 MB)

Tipus de document

Article

Versió

Versió acceptada

Data de publicació

2024-03-01

Llicència de publicació

cc-by-nc-nd (c) Elsevier, 2024
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/217346

Academic challenges on advanced therapy medicinal products’ development: a regulatory perspective

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1016/j.jcyt.2023.12.005

Resum

Advanced therapy medicinal products (ATMPs) are becoming the new kid on the block for the treatment of a variety of indications with promising results. Despite the academic contribution to the basic and clinical research of ATMPs, undertaking a full product development process is extraordinarily challenging and demanding for academic institutions. Meeting regulatory requirements is probably the most challenging aspect of academic development, considering the limited experience and resources compared with pharmaceutical companies. This review aims to outline the key aspects to be considered when developing novel ATMPs from an academic perspective, based on the results of our own experience and interaction with the Spanish Agency of Medicines and Medical Devices (AEMPS) and European Medicine Agency (EMA) related to a number of academic ATMP initiatives carried out at our center during the last 5 years. Emphasis is placed on understanding the regulatory requirements during the early phases of the drug development process, particularly for the preparation of a Clinical Trial Application. Academic centers usually lack expertise in product-related documentation (such as the Investigational Medicinal Product Dossier), and therefore, early interaction with regulators is crucial to understand their requirements and receive guidance to comply with them. Insights are shared on managing quality, nonclinical, clinical, and risk and benefit documentation, based on our own experience and challenges. This review aims to empower academic and clinical settings by providing crucial regulatory knowledge to smooth the regulatory journey of ATMPs.

Matèries

Desenvolupament de medicaments, Investigació mèdica, Assaigs clínics, Qualitat dels productes, Fabricació

Matèries (anglès)

Drug development, Medicine research, Clinical trials, Quality of products, Manufacturing processes

Citació

Col·leccions

Articles publicats en revistes (Fonaments Clínics)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Citació

OLESTI MUÑOZ, Eulàlia, NUEVO, Yoana, BACHILLER, Mireia, GUILLEN, Elena, BASCUAS, Juan, VAREA, Sara, SÁEZ PEÑATARO, Joaquín, CALVO ROJAS, Gonzalo. Academic challenges on advanced therapy medicinal products’ development: a regulatory perspective. _Cytotherapy_. 2024. Vol. 26, núm. 3, pàgs. 221-230. [consulta: 5 de gener de 2026]. ISSN: 1465-3249. [Disponible a: https://hdl.handle.net/2445/217346]

Exportar metadades

JSON - METS

Compartir registre