Due to the complexity of therapy development processes for different types of gene and cell therapies, and the various interests among all stakeholders involved, multiple pathways bringing therapies from the lab to clinic exists. EuroGCT’s key resources have been carefully designed, compiled and curated to meet the various stakeholders’ needs in improved access to practical steps regarding gene and cell therapy development. Listed below are several suggested routes to take for a few exemplar types of stakeholders:
For regulators in the wide meaning as any competent authorities (see also: Actors and Network), including but not limited to those from Medicines Agencies, National competent authorities, HTA Bodies, Ethics Committees, Data Authorities, Patent Offices, Research Funding Authorities, depending on your involvement in the regulatory processes, we suggest you to focus on different parts of the Research Pathways:
- For all types of regulators, we hope the compiled “European Union Legislation”, “European Union Guidance”, and “Relevant Literature” sections along all pathways will be useful to you.
- For regulators focusing on a specific part of product development, please see the Themes that are relevant to your work. For example, we suggest regulators from the GMO authorities or from non-clinical research areas, to have a look at the clinical research part.
For biomedical science researchers with a main focus on basic science, please consult the themes “Research and Innovation” and its subcategories “Fundamental Research” and “Clinical Research”. If your research involves patients, we suggest looking at resources indexed with the “Patient & Public Involvement” theme, or to search for resources that may be useful for you in the ATMP Engage PPI Directory as well as “Clinical Research” subcategory within the “Research and Innovation” theme.
For developers and researchers who aims to bring a therapy to the market, please see all themes within Research Pathways. Focus should be placed on the “Challenges”, “Opportunities and incentives”, “practical steps”, and “Interactions with regulators” sections within each entry across all stages. If you are interested in learning about how a specific product was brought to market, please see the Case Studies section.
For patients and the public who are interested in learning about the development processes of gene and cell therapies, we’d suggest you start from the “introduction” section and dive in as much as you would like. The “Conditions and diseases” within the search filters may also help you to look for information on therapies developed or under development for treating specific conditions. However, the Research Pathways section mainly focusses on the therapy development processes and requirements, information about condition-specific treatments is likely limited there. More information on this can be found from a different part of the EuroGCT website, either from the Discover section or via the drop-down lists from the “Condition” and “Theme” panels in our website’s top banner: 
We welcome comments on how we can enhance the contents and the website navigation. Please contact us to help us improve our activities and learn from those who use EuroGCT.
Published: 05/06/2024
