Results 51 to 60 of about 7,093,593 (187)

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

Challenges for Economic Evaluations of Advanced Therapy Medicinal Products: A Systematic Review [PDF]

, 2022
Objectives: Advanced therapy medicinal products (ATMPs) are drugs for human use for the treatment of chronic, degenerative, or life-threatening diseases that are based on genes, tissues, or cells.
Olry de Labry Lima, Antonio, Epstein, David Mark, Pérez Troncoso, Daniel, García Mochón, Leticia   +3 more
core   +1 more source

First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft

EBioMedicine, 2020
Background: Small cardiac tissue engineering constructs show promise for limiting post-infarct sequelae in animal models. This study sought to scale-up a 2-cm2 preclinical construct into a human-size advanced therapy medicinal product (ATMP; PeriCord ...
Cristina Prat-Vidal, Luciano Rodríguez-Gómez, Miriam Aylagas, Nuria Nieto-Nicolau, Paloma Gastelurrutia, Elba Agustí, Carolina Gálvez-Montón, Ignasi Jorba, Albert Teis, Marta Monguió-Tortajada, Santiago Roura, Joaquim Vives, Silvia Torrents-Zapata, María Isabel Coca, Laura Reales, María Luisa Cámara-Rosell, Germán Cediel, Ruth Coll, Ramon Farré, Daniel Navajas, Anna Vilarrodona, Joan García-López, Christian Muñoz-Guijosa, Sergi Querol, Antoni Bayes-Genis   +24 more
doaj   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Treatment with Tumor-infiltrating Lymphocytes in Advanced Melanoma Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product [PDF]

, 2018
Tumor-infiltrating lymphocytes (TIL)-therapy in advanced melanoma is an advanced therapy medicinal product (ATMP) which, despite promising results, has not been implemented widely.
van den Berg, Joost H., John B. Haanen, Valesca P. Retèl, Van Harten, Wim H., Geukes Foppen, Marnix H., Retl, Valesca P., Lindenberg, Melanie A., Melanie A. Lindenberg, Haanen, John B., Lindenberg, Melanie A.; id_orcid, Marnix H. Geukes Foppen, Joost H. van den Berg, Wim H. van Harten   +12 more
core   +2 more sources

Human umbilical cord-derived mesenchymal stem/stromal cells: a promising candidate for the development of advanced therapy medicinal products

Stem Cell Research & Therapy, 2021
Umbilical cord-derived mesenchymal stem/stromal cells (UC-MSCs) emerge as a perspective for therapeutic use in immune and inflammatory diseases. Indeed, immunomodulatory and anti-inflammatory properties, associated to fewer ethical, availability, and ...
Miryam Mebarki, Camille Abadie, Jérôme Larghero, Audrey Cras   +3 more
doaj   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Molecular Therapy: Methods & Clinical Development, 2019
Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission.
Giulia Detela, Anthony Lodge
doaj   +1 more source