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Bringing gene and cell therapies from the lab bench to patients is a complex process and multiple pathways exists. The Research Pathways directory contains resources to help various stakeholders interested in therapy development navigate this process. Research Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in Europe and further expanded to additional aspects. It is free to use and all resources in this database are categorised for improved searchability.
How to use Research Pathways EuroGCT's Key Resources
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Signposting to key resources on ATMP development
Learn from specific development cases and relevant resources
ATMP Engage Patient and Public Involvement Directory
Mapping the stakeholders in Europe and beyond
Policy impacting gene and cell therapy development in Europe
Signposting to key resources on ATMP development
Learn from specific development cases and relevant resources
ATMP Engage Patient and Public Involvement Directory
Mapping the stakeholders in Europe and beyond
Policy impacting gene and cell therapy development in Europe
Lay summary of an SSH paper entitled "Understanding European Union Substances of Human Origin Case Law through Defragmentation and Fragmentation"
Theme
- Show all 3
- ATMPs
- Not ATMPs: Human body elements for therapeutic applications
- Not ATMPs: medical devices containing tissues and cells
The ATTEST case study shows how Accession Therapeutics, working with the Cardiff Experimental Cancer Medicine Centre (ECMC), embedded PPIE in the early development of its oncolytic genetically modified virus to improve trial design, strengthen regulatory engagement and reduce development risks and delays.
Theme
- Show all 3
- Clinical research
- ATMPs
- Patient & Public Involvement
EuroGCT Resource Patentability of biotechnology and ATMP-related inventions in Europe, including human cells, genes, stem cells and organoids
Theme
- Show all 2
- Research and Innovation
- Incentives
The case study of Rinri’s cell therapy for hearing loss demonstrates how early PPIE can shape trial design, strengthen regulatory readiness, reduce development risks and improve efficiency.
Theme
- Show all 3
- Clinical research
- ATMPs
- Patient & Public Involvement
The article makes the case for Patient and Public Involvement and Engagement (PPIE) as a strategic and commercial investment. By bringing patient insights into clinical development early, PPIE can help identify potential barriers, reduce costly risks and support more efficient decision-making. Such early engagement is particularly valuable in ATMP development where small patient populations, complex procedures and high uncertainty can amplify the impact of delays and design issues.
Theme
- Show all 4
- Clinical research
- ATMPs
- Market access for ATMPs
- Patient & Public Involvement
EuroGCT Resource Manufacturers of medical devices containing human or animal tissues or cells must meet the general requirements of the EU Medical Devices Regulation, plus extra obligations
Theme
- Show all 3
- Therapy classification
- Not ATMPs: Human body elements for therapeutic applications
- Not ATMPs: medical devices containing tissues and cells
EuroGCT Resource Medical devices differ from medicines both in how they work and how they are regulated. This resource focuses on the commercialisation of medical devices utilising tissues or cells of animal origin. an area where classification can be complex. It will NOT address the aspects related to national legislations such as reimbursement, prescription or advertising.
Theme
- Show all 4
- Therapy classification
- Not ATMPs: Human body elements for therapeutic applications
- Not ATMPs: medical devices containing tissues and cells
- Commercialisation
EuroGCT Resource This resource explains how medical devices differ from medicines, both in how they work and how they are regulated. It focuses on the commercialisation of medical devices utilising tissues or cells of human origin. an area where classification can be complex.
Theme
- Show all 3
- Therapy classification
- Not ATMPs: Human body elements for therapeutic applications
- Not ATMPs: medical devices containing tissues and cells
The poster outlines how the proposed EU Biotech Regulation could affect ATMPs through changes to ATMP and clinical trial rules, including some exemptions, faster approvals, and simpler procedures. It also introduces new support measures such as an ATMP classification repository and recognised centres of excellence.
Poster - Specific guidelines requirements for clinical trials with Advanced Therapy Medicinal Products in the EU
Theme
- Show all 2
- Clinical research
- ATMPs
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