Results 31 to 40 of about 1,892 (131)

Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Frontiers in Medicine, 2022
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory ...
Maja Pizevska, Jaspal Kaeda, Enrico Fritsche, Hisham Elazaly, Petra Reinke, Petra Reinke, Leila Amini, Leila Amini   +7 more
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Defining a Regulatory Strategy for ATMP/Aerosol Delivery Device Combinations in the Treatment of Respiratory Disease

Pharmaceutics, 2020
Advanced Therapeutic Medicinal Products (ATMP) are a heterogenous group of investigational medicinal products at the forefront of innovative therapies with direct applicability in respiratory diseases.
Niamh Woods, Ronan MacLoughlin
doaj   +1 more source

The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review

Molecular Therapy: Methods & Clinical Development
Advanced therapy medicinal products (ATMPs) require rigorous quality management to mitigate risks associated with their development and use in hospitals.
Junnan Shi, Jinagya Yang, Yu Zheng, Phyllis Hio Hong Wong, Hao Hu, Carolina Oi Lam Ung   +5 more
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Can cell and gene therapies improve cognitive symptoms in Parkinson’s disease?

Journal of Integrative Neuroscience, 2022
Advanced therapeutic medicinal products (ATMPs), including cell and gene therapies, are in development for Parkinson’s disease (PD). In many cases, the goal is to replace the lost dopamine (DA), which is anticipated to improve motor dysfunctions ...
Mariah J. Lelos
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

Towards novel reimbursement models for expensive advanced therapy medicinal products (ATMPs)

Swiss Medical Weekly, 2020
Currently, a major focus of biomedical research and clinical application are the so-called advanced therapy medicinal products (ATMPs), which are highly complex medicines that enable the targeted and personalised treatment of patients. The potential of
Dario Picecchi, Katrin Bertram, Dominik Brücher, Michael Bauer   +3 more
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Surgery Versus ATMPs: An Example From Ophthalmology

Frontiers in Bioengineering and Biotechnology, 2020
Advanced therapy medicinal products (ATMPs) are the new frontier of medicine. Advanced therapy medicinal products are set out to satisfy unmet medical needs and provide new innovative, cutting-edge therapies for serious or life-threatening diseases, thus
Federica M. Magrelli, Alessia Merra, Graziella Pellegrini, Graziella Pellegrini   +3 more
doaj   +1 more source

Variation in Health Technology Assessment recommendations and reimbursement of Advanced Therapy Medicinal Products across nine european countries

Discover Health Systems
Background Advanced Treatment Medicinal Products (ATMPs) are innovative treatments aimed at severe diseases. However, patient access varies across European countries. The present research reviews the reimbursement status of the licensed ATMPs in England,
Paraskevi M. Georgiou, Kostas P. Athanasakis   +1 more
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Microbiological Aspects of Pharmaceutical Manufacturing of Adipose-Derived Stem Cell-Based Medicinal Products

Cells, 2023
Subcutaneous adipose tissue is an excellent source of mesenchymal stem cells (ADSCs), which can be used in cell therapies as an active substance in advanced therapy medicinal products (ATMPs).
Ilona Szabłowska-Gadomska, Monika Humięcka, Joanna Brzezicka, Anna Chróścicka, Joanna Płaczkowska, Tomasz Ołdak, Malgorzata Lewandowska-Szumiel   +6 more
doaj   +1 more source

Innovation and competition in advanced therapy medicinal products

EMBO Molecular Medicine, 2019
Graphical Abstract Advanced therapy medicinal products (ATMPs), including gene therapy, cell therapy and tissue engineering products, represent a paradigm shift in health care, but they are expensive. E. Seoane‐Vazquez, V. Shukla and R. Rodriguez‐Monguio
Enrique Seoane‐Vazquez, Vaishali Shukla, Rosa Rodriguez‐Monguio   +2 more
doaj   +1 more source