Results 11 to 20 of about 1,892 (131)

A roadmap for supporting the development of advanced therapy medicinal products in a European framework. [PDF]

Lancet Reg Health Eur
Summary: Advanced therapy medicinal products (ATMPs) represent a paradigm shift in medicine; however, their implementation in European health systems is often hampered by EU regulations.
Van Eldere J, Aiuti A, Lluesma SM, Møller BK, Laursen BE, Lebbe C, Piris A, Carmona J, Goldsobel G, Kintscher U, Vandenberghe P, Huys I, Geers B, Benjamin R, Potter V, Bonini C, Ciceri F, Martino G, Debets R, van der Kuy HPHM, Mielke S, Blomberg P, Ellis E, Müller AMS, Worel N, Künkele A.   +25 more
europepmc   +2 more sources

Accelerating the Worldwide Adoption of Blockchain Technology

Blockchain in Healthcare Today, 2023
“To understand innovation you should ask "why not?" and not "why?" Selling (blockchain) is a problem and people and companies are blocking adoption which prevents innovation within a company, and stymies costs savings and  efficientcy - that is the ...
Raja Sharif
doaj   +1 more source

The complex price setting and reimbursement of non-industrial advanced therapy medicinal products. [PDF]

Health Econ Rev
Background Advanced Therapy Medicinal Products (ATMPs) developed under the Hospital Exemption (HE) offer innovative treatments for patients with unmet medical needs, but their pricing and reimbursement (P&R) remain fragmented and poorly understood.
Špacírová Z, Rejon-Parrilla JC, Espín J.   +2 more
europepmc   +2 more sources

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

Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

Frontiers in Pharmacology, 2021
Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved
Carolina Iglesias-Lopez, Antònia Agustí, Antònia Agustí, Antonio Vallano, Antonio Vallano, Merce Obach   +5 more
doaj   +1 more source

The Relevance of Advanced Therapy Medicinal Products in the Field of Transplantation and the Need for Academic Research Access: Overcoming Bottlenecks and Claiming a New Time

Transplant International, 2023
The field of transplantation has witnessed the emergence of Advanced Therapy Medicinal Products (ATMPs) as highly promising solutions to address the challenges associated with organ and tissue transplantation.
Lorenzo Piemonti, Hanne Scholz, Dide de Jongh, Dide de Jongh, Julie Kerr-Conte, Aart van Apeldoorn, James A. M. Shaw, Marten A. Engelse, Eline Bunnik, Markus Mühlemann, Karolina Pal-Kutas, William E. Scott, Jérémy Magalon, Jérémy Magalon, Patrick Kugelmeier, Ekaterine Berishvili   +15 more
doaj   +1 more source

Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers

Frontiers in Public Health, 2021
Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all ...
Tingting Qiu, Shuyao Liang, Yitong Wang, Claude Dussart, Borislav Borissov, Mondher Toumi   +5 more
doaj   +1 more source

Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies

Pharmaceutics, 2022
Advanced therapy medicinal products (ATMPs) are medicines for human use based on genes, cells or tissue engineering. After clear successes in adults, the nascent technology now sees increasing pediatric application.
Carsten W. Lederer, Lola Koniali, Tina Buerki-Thurnherr, Panayiota L. Papasavva, Stefania La Grutta, Amelia Licari, Frantisek Staud, Donato Bonifazi, Marina Kleanthous   +8 more
doaj   +1 more source

Advanced Therapy Medicinal Products in Vitiligo; Current Status, Future Prospect, and Approved Treatments [PDF]

Cell Journal, 2023
Vitiligo is an auto-immune disease, causing depigmentation of skin in 0.2-1.8% of global population. Topicalcorticosteroids and calcineurin inhibitors are the only treatments with firm evidence of optimal effectiveness withconsiderable side effects ...
Shahriar Ghashghaei, Mahkameh Abbaszadeh, Shahedeh Karimi, Leila Ataie-Fashtami, Amir Bajouri, Massoud Vosough   +5 more
doaj   +1 more source

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework

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, Ana de la Mata, Sara Galindo, Francisco Blázquez, Margarita Calonge, Teresa Nieto-Miguel   +5 more
doaj   +1 more source