Results 31 to 40 of about 7,238,985 (145)

Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals

Molecular Therapy: Methods & Clinical Development, 2020
Advanced therapy medicinal products (ATMPs) comprising cell therapy, gene therapy, and tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide range of severe and debilitating diseases.
Magdi Elsallab, Christopher A. Bravery, Andreas Kurtz, Mohamed Abou-El-Enein   +3 more
doaj   +1 more source

Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries

Frontiers in Pharmacology, 2021
Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health ...
Lucia Gozzo, Lucia Gozzo, Giovanni Luca Romano, Francesca Romano, Serena Brancati, Laura Longo, Daniela Cristina Vitale, Filippo Drago, Filippo Drago, Filippo Drago   +9 more
doaj   +1 more source

Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption

Journal of Market Access & Health Policy, 2019
Background: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises cell therapies, gene therapeutics and tissue engineered products. After implementation of the Regulation 1394/2007, only a couple of products have obtained a centralized ...
Claudia Eder, Claudia Wild
doaj   +1 more source

Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

Frontiers in Immunology, 2012
Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for
Janis eAncans
doaj   +1 more source

Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations?

Journal of Pharmaceutical Policy and Practice, 2021
Background Advanced therapy medicinal products (ATMPs) represent an important cornerstone for innovation in healthcare. However, uncertainty on the value, the high average cost per patient and their one-shot nature has raised a debate on their assessment
Virginia Ronco, Myriam Dilecce, Elena Lanati, Pier Luigi Canonico, Claudio Jommi   +4 more
doaj   +1 more source

Current landscape of clinical development and approval of advanced therapies

Molecular Therapy: Methods & Clinical Development, 2021
Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ...
Carolina Iglesias-Lopez, Antonia Agustí, Antoni Vallano, Merce Obach   +3 more
doaj   +1 more source

Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

Stem Cells International, 2018
Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules.
Mariele Viganò, Silvia Budelli, Cristiana Lavazza, Tiziana Montemurro, Elisa Montelatici, Stefania de Cesare, Lorenza Lazzari, Anna Rosa Orlandi, Giovanna Lunghi, Rosaria Giordano   +9 more
doaj   +1 more source

2023, A Landmark Year in Biomedical Research; A Turning Point in Medical History [PDF]

Cell Journal
The rapid development of knowledge on healthy nutrition, and hygiene practices, as well as the advent of antibioticsand vaccines, has led to increased life expectancy in the recent century.
Bahareh Sadri, Massoud Vosough
doaj   +1 more source

Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework

Frontiers in Medicine, 2017
Advanced therapy medicinal products (ATMPs) have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may potentially provide cure for several genetic diseases.
Marta Carvalho, Bruno Sepodes, Ana Paula Martins   +2 more
doaj   +1 more source

Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries

Regenerative Therapy, 2022
Introduction: Autologous chondrocytes (ACs) are Human cell/tissue-based products used for the treatment of joint cartilage defects. Regulatory agencies have established regulations related to ACs to ensure their safety and efficacy.
Jiwon Kim, Jaehong Park, Seung-Yeon Song, Eunyoung Kim   +3 more
doaj   +1 more source