Preclinical study for treatment of hypospadias by advanced therapy medicinal products
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DOI: 10.1007/s00345-019-02864-x
Abstract: This paper explores the feasibility of a new therapy for the treatment of hypospadias patients. Hypospadias is a very common congenital malformation of male genitals, with very high rate of recurrences after surgery. The field… read more here.
Keywords: therapy medicinal; treatment; advanced therapy; study ... See more keywords
The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001
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DOI: 10.1038/s41409-021-01463-y
Abstract: In February 2021, the ‘Advanced Therapy Medicinal Product’ (ATMP) ARI-0001 (CART19-BE-01), developed at Hospital Clínic de Barcelona (Spain), received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) under the ‘hospital exemption’ (HE)… read more here.
Keywords: advanced therapy; therapy medicinal; ari 0001; hospital exemption ... See more keywords
Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union.
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DOI: 10.1089/hum.2021.058
Abstract: Advanced Therapy Medicinal Products (ATMPs), such as gene therapies that consist of or contain Genetically Modified Organisms (GMOs) need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State,… read more here.
Keywords: therapy medicinal; advanced therapy; clinical trials; gmo ... See more keywords
Managing access to advanced therapy medicinal products: Challenges for NHS Wales
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DOI: 10.1111/bcp.14286
Abstract: Advanced Therapy Medicinal Products (ATMPs), which include gene, somatic cell therapies and tissue‐engineered medicines, have the potential to transform current care pathways by offering durable and potentially curative outcomes. However, they are exceptionally expensive, with… read more here.
Keywords: therapy medicinal; access advanced; medicinal products; advanced therapy ... See more keywords
Advanced therapies push regulatory boundaries
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DOI: 10.15252/embr.201745345
Abstract: The regulation of new medical applications has always been lagging behind the science that enabled these therapies in the first place, but emerging therapeutic approaches are pushing the boundaries harder than ever. Although fundamental principles… read more here.
Keywords: therapy medicinal; medicinal products; advanced therapy; therapies push ... See more keywords
Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson’s Disease to the Clinic: The Investigator’s Perspective
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DOI: 10.3233/jpd-212563
Abstract: There is much excitement around the use of advanced therapy medicinal products (ATMPs), including cell and gene treatments, in Parkinson’s disease (PD). However, taking an ATMP to clinical trials in patients with PD is complex.… read more here.
Keywords: advanced therapy; products atmps; therapy medicinal; parkinson disease ... See more keywords
Two Decades of Global Progress in Authorized Advanced Therapy Medicinal Products: An Emerging Revolution in Therapeutic Strategies
Sign Up to like & getrecommendations! Published in 2020 at "Frontiers in Cell and Developmental Biology"
DOI: 10.3389/fcell.2020.547653
Abstract: The introduction of advanced therapy medicinal products (ATMPs) to the global pharma market has been revolutionizing the pharmaceutical industry and has opened new routes for treating various types of cancers and incurable diseases. In the… read more here.
Keywords: therapy medicinal; market size; medicinal products; advanced therapy ... See more keywords
Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective
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DOI: 10.3389/fmed.2022.757647
Abstract: 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 frameworks. Legislation and regulation requirements for… read more here.
Keywords: advanced therapy; translation europe; products translation; medicinal products ... See more keywords
Education for the translation of Advanced Therapy Medicinal Products
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DOI: 10.3389/fmed.2023.1125892
Abstract: COPYRIGHT © 2023 Adamo, Attico and Pellegrini. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided… read more here.
Keywords: advanced therapy; education translation; medicinal products; therapy medicinal ... See more keywords
Corrigendum: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
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DOI: 10.3389/fphar.2020.00766
Abstract: [This corrects the article DOI: 10.3389/fphar.2019.00921.]. read more here.
Keywords: framework advanced; therapy medicinal; medicinal products; advanced therapy ... See more keywords
GMP-Grade Manufacturing and Quality Control of a Non-Virally Engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration
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DOI: 10.3390/biomedicines10112777
Abstract: The introduction of new therapeutics requires validation of Good Manufacturing Practice (GMP)-grade manufacturing including suitable quality controls. This is challenging for Advanced Therapy Medicinal Products (ATMP) with personalized batches. We have developed a person-alized, cell-based… read more here.
Keywords: advanced therapy; quality; grade manufacturing; gmp grade ... See more keywords