The rapid development of knowledge on healthy nutrition, and hygiene practices, as well as the advent of antibiotics and vaccines, has led to increased life expectancy in the recent century. The extended lifespan has brought new challenges for healthcare professionals, including the management of chronic degenerative diseases, malignancies, and autoimmune disorders. Advanced therapeutic medicinal products (ATMPs) have emerged as a promising frontier alongside conventional therapeutic modalities, offering innovative solutions through cell-based therapies, gene therapy, and tissue engineering. Recent years have witnessed remarkable advancements in regenerative medicine and the launching of innovative ATMPs. Numerous ATMPs have been registered and approved by regulatory agencies for the management of different diseases in 2023. The approval of groundbreaking therapies around the world has made 2023 an exceptional year. Novel ATMPs and the development of artificial intelligence (AI) in 2023 will pave the way for the integration of ATMPs and advanced technologies in personalized medicine, early diagnosis and targeted treatments.
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| http://dx.doi.org/10.22074/cellj.2024.2024274.1523 | DOI Listing |
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Value attributes of advanced therapy medicinal products: a documentary analysis of comments received from stakeholders during reimbursement decisions to England's National Institute of Health and Care Excellence.
Expert Rev Pharmacoecon Outcomes Res
January 2025
Comprehensive Clinical Trials Unit, University College London, London, UK.
Objectives: Advanced therapy medicinal products (ATMPs) are transformative healthcare interventions, however, there has been limited research exploring their value. The objective of this study was to conduct a thematic analysis as part of a documentary analysis to identify value attributes of ATMPs.
Methods: As part of the NICE assessment processes in England, stakeholders are invited to provide comments on the technology.
Considerations for manufacturing of cell and gene medicines for clinical development.
Cytotherapy
December 2024
Cancer Institute, University College London, London, UK. Electronic address:
The global changes from 2001 that elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst for the dramatic expansion of the field to its current and future commercial success. Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC), which led to the development of the term "advanced therapy medicinal products" (ATMPs) to cover all substantially modified products, tissue-engineered products and somatic cells that are not substantially modified but that are used non-homologously. For convenience, I use the term "ATMPs" throughout this review.
View Article and Find Full Text PDFThe role of hospital pharmacists in supporting the appropriate and safe use of CGT/ATMPs: a scoping review of current insights.
BMC Health Serv Res
January 2025
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Background: The role of hospital pharmacists in managing cell and gene therapy (CGT) and advanced therapy medicinal products (ATMPs) is gradually being recognized but the evidence about impact of their role has not been systematically reported.
Objective: This study was aimed to summarize the professional services provided by hospital pharmacists on managing CGT/ATMPs and the evidence about the effects on patient care, as well as to identify the perceptions about pharmacists assuming a role that supports the appropriate and safe use of CGT/ATMPs.
Methods: Literature from 4 electronic databases (PubMed, ScienceDirect, Web of Science, Scopus) were searched following PRISMA checklist to yield publications on the interventions provided by hospital pharmacists in the management of CGT/ATMPs dated since 1 January 2013 till 30 April 2023.
CTGCT, Centre of Excellence for the Technologies of Gene and Cell Therapy: Collaborative translation of scientific discoveries into advanced treatments for neurological rare genetic diseases and cancer.
Comput Struct Biotechnol J
December 2024
Centre for the Technologies of Gene and Cell Therapy, National Institute of Chemistry, Hajdrihova 19, SI1000 Ljubljana, Slovenia.
Article Synopsis
- The Centre of Excellence for the Technologies of Gene and Cell Therapy (CTGCT) has been established at the National Institute of Chemistry in Ljubljana, marking Slovenia’s first center dedicated to precision medicine and cutting-edge therapies.
- The CTGCT aims to advance cancer immunotherapy and personalized treatments for genetic diseases by developing innovative biomedical tools and collaborating with international institutions for effective therapy development.
- Its focus on translating research into practice, alongside partnerships with clinicians and patient organizations, positions the CTGCT as a key player in improving access to gene and cell therapies across Slovenia and the broader Eastern European region.
A Systematic Review of Challenges and Opportunities in the Implementation of Managed Entry Agreements for Advanced Therapy Medicinal Products.
Clin Ther
December 2024
Department of Epidemiology & Health Economics, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. Electronic address:
Purpose: Managed Entry Agreements (MEAs) are agreements between firms and competent authorities for pricing and reimbursement, designed to enable coverage of new medicines while managing uncertainties around their financial impact or performance. Although these agreements can facilitate patient access, their complexity and costs seem to dampen enthusiasm for implementation. Nevertheless, MEAs remain a potential route, particularly for high-cost drugs with uncertain value claims.
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