Additive manufacturing in drug delivery: Innovative drug product design and opportunities for industrial application

H Ragelle, S Rahimian, EA Guzzi… - Advanced Drug Delivery …, 2021 - Elsevier
Additive manufacturing (AM) or 3D printing is enabling new directions in product design. The
adoption of AM in various industrial sectors has led to major transformations. Similarly, AM …

Two decades of global progress in authorized advanced therapy medicinal products: an emerging revolution in therapeutic strategies

R Ramezankhani, S Torabi, N Minaei… - Frontiers in Cell and …, 2020 - frontiersin.org
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 …

Regulatory framework for advanced therapy medicinal products in Europe and United States

C Iglesias-Lopez, A Agustí, M Obach… - Frontiers in …, 2019 - frontiersin.org
Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative
therapies. The European Union (EU) and the United States (US) are fostering their …

HTA methodology and value frameworks for evaluation and policy making for cell and gene therapies

D Coyle, I Durand-Zaleski, J Farrington… - The European Journal of …, 2020 - Springer
This last decade has been marked by significant advances in the development of cell and
gene (C&G) therapies, such as gene targeting or stem cell-based therapies. C&G therapies …

[HTML][HTML] Advanced therapy medicinal products challenges and perspectives in regenerative medicine

A Goula, V Gkioka, E Michalopoulos… - Journal of Clinical …, 2020 - ncbi.nlm.nih.gov
Recently, the design and development of a modern health policy in the field of regenerative
medicine leads to the formation of a new and integrated cognitive field, which requires …

State of the art review of cell therapy in the treatment of lung disease, and the potential for aerosol delivery

H Brave, R MacLoughlin - International Journal of Molecular Sciences, 2020 - mdpi.com
Respiratory and pulmonary diseases are among the leading causes of death globally.
Despite tremendous advancements, there are no effective pharmacological therapies …

Regenerative medicine regulatory policies: a systematic review and international comparison

T Qiu, E Hanna, M Dabbous, B Borislav, M Toumi - Health Policy, 2020 - Elsevier
Background A small number of regenerative medicines (RMs) have received market
authorization (MA) worldwide, relative to the large number of clinical trials currently being …

Mitigating deficiencies in evidence during regulatory assessments of advanced therapies: a comparative study with other biologicals

M Elsallab, CA Bravery, A Kurtz… - … Therapy Methods & …, 2020 - cell.com
Advanced therapy medicinal products (ATMPs) comprising cell therapy, gene therapy, and
tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide …

Current landscape of clinical development and approval of advanced therapies

C Iglesias-Lopez, A Agustí, A Vallano… - … Therapy-Methods & …, 2021 - cell.com
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 …

[HTML][HTML] The relevance of advanced therapy medicinal products in the field of transplantation and the need for academic research access: overcoming bottlenecks and …

L Piemonti, H Scholz, D de Jongh… - Transplant …, 2023 - frontierspartnerships.org
The field of transplantation has witnessed the emergence of Advanced Therapy Medicinal
Products (ATMPs) as highly promising solutions to address the challenges associated with …