Advanced therapy medicinal products in China: Regulation and development [PDF]
MedComm, 2023 Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies ...
Jiaqi Lu, Longchang Xu, Wei Wei, Wu He
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Is the Conjunctiva a Potential Target for Advanced Therapy Medicinal Products? [PDF]
Pharmaceutics, 2021 The conjunctiva is a complex ocular tissue that provides mechanical, sensory, and immune protection for the ocular surface. It is affected by many diseases through different pathological mechanisms.
Yolanda Diebold, Laura García-Posadas
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Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective [PDF]
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 +7 more
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Education for the translation of Advanced Therapy Medicinal Products [PDF]
Frontiers in Medicine, 2023 Davide Adamo +3 more
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Advanced Therapy Medicinal Products for Eye Diseases: Goals and Challenges [PDF]
Pharmaceutics, 2021 Advanced therapy medicinal products (ATMPs) are a novel class of medicines with enormous potential to improve treatments for a wide range of diseases, including those affecting eye structures [...]
Yolanda Diebold, Laura García-Posadas
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Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework [PDF]
Pharmaceutics, 2021 Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called ...
Marina López-Paniagua +5 more
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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 +2 more
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Defining core competencies for advanced therapy medicinal products translation [PDF]
Frontiers in Digital HealthBackgroundTranslating Advanced Therapy Medicinal Products (ATMPs) from research to clinical application requires a specialized set of priority topic areas that is not yet systematically defined.MethodsWe employed a multi-phase approach combining a ...
Elena Guillen +2 more
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Potency assays and biomarkers for cell-based advanced therapy medicinal products [PDF]
Frontiers in Immunology, 2023 Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development, even more so following the marketing approval of several such products.
Chiara Capelli +22 more
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Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion [PDF]
Biomedicine Hub, 2020 Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of
Denis Horgan +17 more
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