# EuroGCT Deliverable D2.9: Update on Research and Regulatory Hub

Hsin-Yu Kuo, Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Auxane Delage, Valentin Roby, Anna Couturier, Jennifer Lorigan, Clare Blackburn

► To cite this version:

Hsin-Yu Kuo, Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Auxane Delage, Valentin Roby, et al. EuroGCT Deliverable D2.9: Update on Research and Regulatory Hub. Commission Européenne. 2025, pp.1-16. halshs-04930218

HAL Id: halshs-04930218

https://shs.hal.science/halshs-04930218v1

Submitted on 8 Aug 2025

HAL is a multi-disciplinary open access
archive for the deposit and dissemination of sci-
entific research documents, whether they are pub-
lished or not. The documents may come from
teaching and research institutions in France or
abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est
destinée au dépôt et à la diffusion de documents
scientifiques de niveau recherche, publiés ou non,
émanant des établissements d'enseignement et de
recherche français ou étrangers, des laboratoires
publics ou privés.

<figure><img src="image_1.png" /></figure>

Distributed under a Creative Commons Attribution 4.0 International License
# Deliverable Report

Grant Agreement Number: 965241

Project acronym: EuroGCT

Project title: European Consortium for Communicating Gene and Cell Therapy Information

Deliverable: D2.9 Update of Research and Regulatory Hub

Report on integration of new information to, content updating in and information uptake from the EuroGCT online research and regulatory community hub

Date: 31st Jan 2025
<table><tr><td colspan="2"><strong>Project</strong></td></tr><tr><td>Project acronym:</td><td>EuroGCT</td></tr><tr><td>Project full title:</td><td>European Consortium for Communicating Gene and Cell Therapy Information</td></tr><tr><td>Grant agreement no.:</td><td>965241</td></tr><tr><td>Funding scheme:</td><td>Co-ordination and Support Action</td></tr><tr><td>Project start date:</td><td>1 February 2021</td></tr><tr><td>Project duration:</td><td>60 months</td></tr><tr><td>Call topic:</td><td>SC1-HCO-19-2020 - Reliable and accessible information on cell and gene-based therapies</td></tr><tr><td>Project website:</td><td>www.eurogct.org</td></tr><tr><td colspan="2"><strong>Document</strong></td></tr><tr><td>Deliverable number:</td><td>D2.9</td></tr><tr><td>Deliverable title:</td><td>Update on Research and Regulatory Hub</td></tr><tr><td>Due date of deliverable:</td><td>Month 48</td></tr><tr><td>Associated Milestones</td><td>NA</td></tr><tr><td>Actual submission date:</td><td>31 Jan 2025</td></tr><tr><td>Last Editor:</td><td>Hsin-Yu Kuo</td></tr><tr><td>Contributors:</td><td>Hsin-Yu Kuo, Aurélie Mahalatchimy, Luc- Sylvain Gilbert, Auxane Delage, Valentin Roby, Anna Couturier, Jennifer Lorigan, Clare Blackburn,</td></tr><tr><td>Work Package no.:</td><td>2</td></tr><tr><td>Work Package title:</td><td>Digital Platforms for Dissemination and Engagement</td></tr><tr><td>Work Package lead beneficiary:</td><td>1 - UEDIN</td></tr><tr><td>Work Package participants:</td><td>All partners</td></tr><tr><td>Dissemination level:</td><td>Public</td></tr><tr><td>Nature:</td><td>Report</td></tr><tr><td>Draft/Final:</td><td>Final</td></tr><tr><td>No of pages (including cover):</td><td>16</td></tr></table>
List of acronyms

ATMP: Advanced Therapy Medicinal Products

EuroGCT: The European Consortium for Communicating Gene and Cell Therapy Information

GCT: Gene and Cell Therapy

IMHT: The EuroGCT Information Management Hub Team, comprised of project staff employed directly by the project, based at the University of Edinburgh (UEDIN) and Aix-Marseille University (AMU)

NoE: Network of Expertise

WP: Work Package
## D2.9 – Update of Research and Regulatory Hub, Report on integration of new information to, content updating in and information uptake from the EuroGCT online research and regulatory community hub

EuroGCT WP4 develops an information hub named Research Pathways (https://www.eurogct.org/research-pathways) for the research and regulatory communities, that facilitates access of these communities to information on the practical steps needed for cell and gene-based therapy development and promotes information exchange within and between these communities. This tailored section of www.eurogct.org aims to create a ‘one-stop shop’ on where to seek further information and guidance relating to manufacturing guidelines, regulatory requirements, intellectual property rights, market acceptability and ethical matters related to advanced therapies development.

Since the last reporting period, significant updates have been made to our Research and Regulatory Hub. Deliverable 2.9 summarises this information provision and its uptake.

### New information and content updates

* **User guides and improved visuals**

Following the feedback from the last review meeting, EuroGCT has worked on features to improve users’ surfing experience while browsing the Research Pathways information hub.

We have first developed a series of user guides (Figure 1) to explain how to navigate the Research Pathways database and how EuroGCT’s key resources could be used. These are:

o The “How to use the Research Pathways” guide (https://www.eurogct.org/how-use-research-pathways), explains how the information is categorised in the database and how users can navigate the interactive interface to find information relevant to them.

o “About EuroGCT’s Key Resources” (https://www.eurogct.org/about-eurogcts-key-resources) describes how EuroGCT’s Key Resources are designed, compiled and curated to help various stakeholders access information on practical steps regarding GCT development. A figure for the Research Pathways Draft Tree (Figure 2) has been published to help our online audience visualise how GCT development pathways are envisioned by the EuroGCT consortium.

o The “Who should use EuroGCT’s Key Resources and how to use them” guide (https://www.eurogct.org/who-should-use-eurogcts-key-resources-and-how-use-them) suggests several routes to take for a few exemplar types of stakeholders when navigating the Research Pathways.

o The “Relevant Literature section of EuroGCT’s Key Resources” (https://www.eurogct.org/relevant-literature-section-eurogcts-key-resources) lists all the online databases the literature review was performed on for the relevant literature section of EuroGCT’s Key Resources.
Bringing gene and cell therapies (GCTs) from the lab to patients is a complex process and different pathways exists for each type of stakeholders. Complementing the information we have compiled and curated, we hope that launching this set of user guides will help our online users better navigate the database and obtain the development guidance they need.

<figure><img src="image_2.png" /><figcaption>Figure 1: Screenshots of the new user guides developed for Research Pathways. (cropped)</figcaption></figure>

<figure><img src="image_3.png" /><figcaption>Figure 2. EuroGCT's Research Pathways Draft Tree. The full figure can be downloaded at: https://www.eurogct.org/sites/default/files/attachments/resources/5t3st5vd_0.png</figcaption></figure>
Other improvements the EuroGCT IMHT made to enhance users' browsing experience for our online material have been to introduce colour-coding for content sections, and to add figures where suitable throughout the entries WP4 has produced (Figure 3). Both actions are taken in response to critiques received from within the partnership about the WP4 entries being too text-heavy and "looks uninteresting" to read. Since the addition of these visual elements, we have received compliments from partners and collaborators. We hope by introducing these visual elements can also improve the engagement for our online target audience.

<figure><img src="image_4.png" /><figcaption>Figure 3. (Left) Screenshot of a EuroGCT's Key Resource with colour-coded sections. (Right) An example page where coloured charts and figures are added. Both screenshots have been cropped.</figcaption></figure>

* New entries for EuroGCT Key resources and updating existing resources

The EuroGCT consortium has committed to increase the breadth and depth of our resource coverage as the project progresses (see D4.1). During this current reporting period, EuroGCT has published our original resource as follows (Figure 4):

o ATMPs: Applicable regulatory pathways (https://www.eurogct.org/research-pathways/therapy-classification/atmps-applicable-regulatory-pathways)

o CAT scientific recommendations on classification (https://www.eurogct.org/research-pathways/therapy-classification/atmps-applicable-regulatory-pathways/cat-scientific)

o "Compassionate use" and "named-patients basis" pathways for ATMPs (https://www.eurogct.org/research-pathways/therapy-classification/atmps-applicable-regulatory-pathways/compassionate-use-and)

o ATMPs specific "Hospital exemption" pathway (https://www.eurogct.org/research-pathways/therapy-classification/atmps-applicable-regulatory-pathways/atmps-specific)
<figure><img src="image_5.png" /><figcaption>Figure 4. Screenshot (cropped) for newly published EuroGCT's Key Resources</figcaption></figure>

EuroGCT has also published several transition pages which connect existing entries based on the Research Pathways Draft Tree (as in D4.8), and they are listed below:

* Expediting marketing authorisation pathways (https://www.eurogct.org/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-pathways)

* Data (https://www.eurogct.org/research-pathways/public-involvement-and-data/data)

* Data protection (https://www.eurogct.org/research-pathways/public-involvement-and-data/data/data-protection)

Reviews and updates have also been made for several existing EuroGCT resources to ensure the information within is up to date.

* Additional language versions of EuroGCT Key resources

Content developed with languages in addition to English enables a greater number of European users to access EuroGCT information in either their native language or a language familiar to them. To further enhance the multilingual aspect of EuroGCT's information provision, WP4 has set out to publish additional language versions of our specialist-facing
content. These contents are not merely translated from their English counterparts—when
developing these materials, cultural, legal and regulatory aspects have all been carefully
considered.

In the current reporting period, WP4 has published 18 entries in French language, as listed
below:

* Prix et prise en charge des médicaments en France (https://www.eurogct.org/fr/research-pathways/commercialisation/pricing-and-reimbursement/pricing-and-reimbursement-national)

* Utilisation abusive / détournée des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/utilisation-abusive-detournee-des-donnees)

* Autorités de protection des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/data-protection/autorites-de-protection-des)

* Accès au marché pour les médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/acces-au-marche-pour-les-medicaments-de-therapie-innovante)

* Accélération des Procédures d'autorisation de mise sur le marché (https://www.eurogct.org/fr/fr/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-pathways)

* Classification des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/data-protection/classification-des-donnees)

* Dossier de demande d'autorisation de mise sur le marché des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/market-access-atmps/standard-marketing-authorisation-pathway)

* Procédure d'évaluation accélérée des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-0)

* Bonnes Pratiques de Fabrication des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/manufacturing/bonnes-pratiques-de-fabrication-des-medicaments-de-therapie)

* Autorisation de mise sur le marché conditionnelle des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-pathways)

* Science Translationnelle (https://www.eurogct.org/fr/research-pathways/research-and-innovation/science-translationnelle)

* Procédure centralisée pour les médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/market-access-atmps/procedure-centralisee-pour-les-medicaments)

* Emballage et étiquetage des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/manufacturing/emballage-et-etiquetage-des-medicaments-de-therapie-innovante)

* Autorisation de fabrication des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/manufacturing/autorisation-de-fabrication-des-medicaments-de-therapie-innovante)
* Collecte, traitement et contrôle des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/collecte-traitement-et-controle-des-donnees)

* Partage des données / Ouverture des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/partage-des-donnees-ouverture-des-donnees)

* Principes fondamentaux de la protection des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/data-protection/principes-fondamentaux)

* Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante (https://www.eurogct.org/fr/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-1)

Several transition pages connecting existing entries were also published:

* Protection des données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/data/protection-des-donnees)

* Données (https://www.eurogct.org/fr/research-pathways/public-involvement-and-data/donnees)

Discussions are ongoing with partners and collaborators both in Spain and Italy to develop or translate contents into Spanish and Italian versions.

* **Case study**

In response to the reviewers' critique that "more storytelling is needed to guide the users through the different steps of product development", we have further worked on case studies which provide storylines for readers to walk through the resources collated in the Research Pathways database.

During the last reporting period, we have published case studies on two approved ATMPs by collating existing publicly available information about each stage of their development to serve as a guide for the research community to learn about these processes. In the current reporting period, we have published a "short" case study to capture researchers'/developers' practical considerations at specific time points during development (Figure 5). This case study is about early classification considerations in developing a skin equivalent for healing wounds - different choices of the preparation steps can result in different therapy classification (ATMP or not ATMP; if ATMP, which subtype) and this in turn determines the requirements that the product must meet, and the relevant procedures leading to commercialisation.

This first short-format case study serves as a demonstration to the partnership on how their experience can be shared with the wider community in the digital space. The small lightbulb moments and thoughts happening within the laboratory often are not revealed in research articles but will benefit many if shared with the larger community.

There are more case studies for additional types of therapies in the pipeline. We are currently collaborating with the CARTALLEU project developing a CAR-T therapy in Spain (see also: D1.10 and D3.4). Through this collaboration, we hope to co-develop a case study about the
development of their CAR-T therapy, to report on the key development processes, guidelines they are following, regulatory support they sought, and this case study will become a learning resource for the researcher and developer community who are working on the same type of therapy. We are also working on a case study with partner 44 on an ATMP they are currently developing. By documenting the processes while the medicinal products are under development, these case studies can show a timeline of events, interactions with regulators, and how resources or guidance were sought along the product development processes.

We are conscious that each ATMP have unique considerations and complexities at every stage in their development process, and these considerations and complexities often are product-specific. EuroGCT aims to try to provide as many case studies as possible, to help researchers and developers find anchor points and use them as references to facilitate their ATMP development activities.

<figure><img src="image_6.png" /><figcaption>Figure 5. (Left) Published Case studies on ATMP development. See: https://www.eurogct.org/case-studies. (Right) A newly-published short case study on therapy classification. See: https://www.eurogct.org/case-study-therapy-classification.</figcaption></figure>

## Online Information Uptake

* Website user statistics

Even though the content in our Research Pathways hub is mainly targeting specialists, a small fraction of the population as opposed to the general public, there is a clear upward trend of unique visitors accessing the information WP4 has published (Figure 6). Comparing traffic trends from mid-2023 to 2024, there has been a noticeable increase in online user engagement with Research Pathways. Within the current reporting period, Research Pathways has attracted a total of 14.2K unique visitors, marking an increase of 12.5 K visitors compared to the previous reporting period. This growth in traffic also led to a rise in unique
views, with 25.5 K views – an increase of 16 K compared to mid-2023. Additionally, the average time spent on the Research Pathways part of the site per visitor increased by 1 minute and 3 seconds, rising from 1:44 in mid-2023 to 02:47 in 2024. These improvements in both visitor numbers and engagement indicate that the site's visibility and impact continue to grow as its content reaches new audiences.

<figure><img src="image_7.png" /><figcaption>Figure 6. All-time users and page views for Research Pathways section (WP4) since the launch of EuroGCT.org based on Fathom analytics. (Darker purple-blue: unique visitors; lighter purple-blue: total views)</figcaption></figure>

EuroGCT's Europe-wide and international reach for the specialist communities has continued to expand, as evidenced by the geographic distribution of our website traffic for Research Pathways pages. The top countries of origin for visitors are (in descending order): United Kingdom, United States of America, France, Germany, and India.

Surprisingly strong uptake by our online audience has been observed in several pieces of EuroGCT's original resources produced by WP4. The entries on "Manufacturing Authorisation of ATMPs", "Marketing Authorisation under exceptional circumstances for ATMPs", "Packaging and labelling of ATMPs" and "Accelerated Assessment of ATMPs" are among the top-accessed pages within our site and comparable to our public-facing factsheets produced in WP3. These pages appear in top 7 search results in Google using relevant query terms, and more often, are ranked within top 3 using exact search terms. We have also recorded a significantly longer user retention time for these EuroGCT original resource pages compared to the average of all Research Pathways pages (02:27) and the average retention time of the entire website (02:04). The detailed user stats and search ranking can be found in Table 1 below:

<table><thead><tr><td>Page title</td><td>Total views</td><td>Average Google search ranking*</td><td>Retention time (mins)</td></tr></thead><tbody><tr><td>Manufacturing Authorisation of ATMPs<fnref n="1" /></td><td>2.6 K</td><td>1.4</td><td>3:37</td></tr></tbody></table>

<footnote n="1">¹ https://www.eurogct.org/research-pathways/manufacturing/manufacturing-authorisation-atmps</footnote>
<table><caption>Table 1. Top WP4 pages having comparable google search click-throughs to the public-facing pages.</caption><tr><td>Marketing Authorisation under exceptional circumstances for ATMPs<sup>2</sup></td><td>1.6 K</td><td>3.2</td><td>4:12</td></tr><tr><td>Packaging and labelling of ATMPs<sup>3</sup></td><td>1.7 K</td><td>6.2</td><td>3:56</td></tr><tr><td>Accelerated Assessment of ATMPs<sup>4</sup></td><td>1.3 K</td><td>5.3</td><td>4:02</td></tr></table>

*Average Google search ranking reports the average ranking when using relevant search term in Google searches.

Consistent to the previous reporting period, we've again observed more views-to-visitor ratio for our directory pages. These pages, including the Research Pathways and ATMP Engage page, received total views that are up to two times higher than their unique visitor number. This is distinct from the resource pages for WP4 and WP3 where the views and unique visitor number are near 1:1 (Table 2). This observation again suggests that these directory pages have started to be used as a reference page for certain user groups as a standing resource for regular re-visit to look up resources. Further supported by the bounce rate for these pages recorded by Fathom Analytics, a higher percentage of users remained on site since visiting such pages--this indicates users are engaging with the online material we are providing.

<table><caption>Table 2. higher views-to-visitors ratio and lower bounce rates for directory pages.</caption><thead><tr><th>Page title</th><th>Type</th><th>Views</th><th>Visitors</th><th>Views / Visitor</th><th>Bounce rate</th></tr></thead><tbody><tr><td>Research Pathways</td><td>Directory</td><td>4.6 K</td><td>2.1 K</td><td><strong>2.2</strong></td><td><strong>46%</strong></td></tr><tr><td>ATMP-Engage</td><td>Directory</td><td>2.2 K</td><td>1.6 K</td><td><strong>1.4</strong></td><td><strong>63%</strong></td></tr><tr><td>Manufacturing Authorisation of ATMPs</td><td>Resource</td><td>2.6 K</td><td>2.2 K</td><td>1.2</td><td>86%</td></tr><tr><td>Marketing Authorisation under exceptional circumstances for ATMPs</td><td>Resource</td><td>1.6 K</td><td>1.4 K</td><td>1.1</td><td>89%</td></tr><tr><td>What conditions can currently be treated using gene and cell therapy?</td><td>Resource</td><td>5.9 K</td><td>4.9 K</td><td>1.2</td><td>83%</td></tr><tr><td>What is Tissue Engineering?</td><td>Resource</td><td>6.9 K</td><td>5.6 K</td><td>1.2</td><td>86%</td></tr></tbody></table>

## Integration into the online information space

During the current reporting period, we have observed the successful integration of EuroGCT's information into the online information space, as evidenced by popular search engines such as Google and Bing displaying EuroGCT's content in their featured snippets (Figure 7). Featured snippets display extracted content from trusted web pages and appear at the top of

<footnote n="2">² https://www.eurogct.org/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-1</footnote>

<footnote n="3">³ https://www.eurogct.org/research-pathways/manufacturing/packaging-and-labelling-atmps</footnote>

<footnote n="4">⁴ https://www.eurogct.org/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-2</footnote>
search results. These snippets are designed to provide users with quick and relevant answers to their queries. For any website, it is desirable to be featured in such position because it can significantly increase the site's online visibility and organic traffic.

<figure><img src="image_8.png" /><figcaption>Figure 7. (Top) EuroGCT's content being displayed in Google Search's featured snippet when searched with relevant keywords. (Bottom) EuroGCT's content being displayed in Bing's featured snippet when searched with relevant keywords. Screenshot of snippets taken on 23 Jan 2025.</figcaption></figure>

This development is particularly important as it indicates that EuroGCT and the Research Pathways material we have created have been both scraped and identified as trustworthy sources of information for both Google (Google Search/Knowledge Graph) and Microsoft (Bing). The impact of this integration into foundational knowledge of ATMP development on these platforms will have wide reaching implications as the EuroGCT consortium continues to position itself as a source of expert perspectives.

Indeed, Research Pathways' online visibility and impact has continued to grow. Since the previous reporting period, we have seen the website traffic visiting Research Pathways pages increase, especially those coming through organic searches. In fact, there is an increased percentage of unique visitors coming from search engines than through direct links to Research Pathways pages even though both numbers have increased (Table 3). While we are pleased to see our online audience growing, we note that in-person dissemination during events where other European GCT experts are present is still of great importance for our specialist-targeting resources, because these interactions contribute to the website visitors visiting via the growing direct/unknown route (Table 3).
<table><caption>Table 3. A higher percentage of Research Pathways users landed on our webpages through organic searches on major search engines than from direct links, and the trend is increasing over time.</caption><thead><tr><td>Referrer</td><td>Visitors (Reporting Period 2)</td><td>Visitors (Reporting Period 3)</td></tr></thead><tbody><tr><td>Google</td><td>1.2 K</td><td>10.6 K</td></tr><tr><td>Bing</td><td>11</td><td>1 K</td></tr><tr><td>Direct/Unknown</td><td>477</td><td>2 K</td></tr><tr><td>Search engine referrer (%)</td><td>72%</td><td>85%</td></tr></tbody></table>

## User feedback

### Stakeholder survey

To gather information and feedback from stakeholders, EuroGCT has introduced a user feedback survey for our WP4 content. The survey is designed to be distributed among GCT experts within our network, and then the experts are encouraged to cascade it within their organisations and networks. This survey will serve as a tool in assessing the impact and utility of EuroGCT WP4's initiatives and resources among the experts' community. The survey has been prepared and is currently being circulated. Listed below are a few comments we've received so far:

> "The EuroGCT Research Pathways website is very well-structured, offering easy access to high-quality information. It is organized into thematic areas that comprehensively cover the challenges in developing Advanced Therapy Medicinal Products (ATMPs). The content is both targeted and concise, making complex topics more accessible, while also providing links to further resources for deeper exploration. This website has been extremely helpful in supporting the initial phases of our CREATIC Horizon 2020 project, providing valuable guidance on regulatory and development processes. I also appreciated that the content has been made available in several languages." [The surveyee has self-identified as a scientist]

> "I appreciate the pedagogical approach of the content, as well as its precision and logical flow. The site effectively highlights the key issues and questions that need to be addressed, which is incredibly useful, particularly for non-legal professionals working on ATMPs. The clarity and structured layout make it easier to navigate complex topics, ensuring that users of all backgrounds can engage with the material effectively." [The surveyee has self-identified as a scientist]

> "This is an admirably comprehensive resource of information on a very complex and multi-dimensional topic. The key resources are helpfully organised into sections organised by stage of therapy development, from basic research to regulatory approval and marketing, which make sense in terms of locating types of information. The subsections and subheadings are also useful although some sections are still necessarily very extensive. The use of explicit definitions and lists of key organisations involved at different steps is also a useful inclusion. The language is for
the most part accessible, although as noted this is a complex subject and in many
cases it is necessary and appropriate to use scientific or legal terms. It is particularly
encouraging to see the section on PPI and it is to be hoped there will be capacity to
update this in future with new case studies of PPI initiatives involving ATMPs as the
number and variety of products in late-stage clinical trials increases."

Base on the small number of responses we received so far, those surveyed have commented that EuroGCT's Research Pathways is useful, well-structured, high quality, and have presented complex information in an accessible way. Suggestions for areas that could benefit from further updates, such as the Public and Patients Involvement (PPI) section, has also been pointed out. We will continue to promote and circulate the survey within our network and use it to evaluate the relevance and quality of the resources we provide in Research Pathways.

* **Informal stakeholder feedback**

Apart from user surveys, we have received various positive feedbacks from stakeholders external to our network during events when in-person dissemination activities are ongoing. For example, at the 2023 ESGCT Congress, representatives from smaller biotech companies have expressed the usefulness of the information WP4 has provided, especially on the marketing authorisation pathways. Several early career researchers expressed interest and praised for the usefulness of EuroGCT's original resources to help them understand what happens beyond early-stage research in labs. A number of academics have expressed the usefulness of the information EuroGCT is presenting, and had asked to re-use our content in their teaching activities. At the 2024 ESGCT Congress, several industry attendees have commented that our "website was useful and very self-explanatory". Additional comments received about our work includes "very useful work as some countries have very limited access to resources on ATMPs regulation", and "a great accomplishment for presenting so much useful information at once than through multiple publications."

To gather feedback within our network, our regular email updates for partners and Network of Expertise (NoE) provide a channel for informal stakeholder feedback. When new website features or content are updated on the website, we flag these to our partners and NoE, and then encourage them to engage with these new updates and send us their thoughts and comments. Our monthly drop-in clinics also offer valuable opportunities for informal feedback from our network. Their feedback has fed into the website updates and for resource formats. Through these feedback mechanisms, the IMHT has the opportunity to informally assess and evaluate our work, to ensure that we are aligned with the targets and expectations of the wider partnership. So far, we have had very positive feedback from the Management Group and partners on our contents, and the steps we've made on improving the functionality of the website.

Conclusion

In the current reporting period, EuroGCT WP4 has made significant updates including publishing Research Pathways user guides, new resources (English and additional language versions), new case studies as well as improved visuals across Research Pathways. Existing resources have also been reviewed and updated.
EuroGCT's online research and regulatory community hub, Research Pathways, has broadened our dissemination actions and made our work accessible to audience in the EU, UK, and worldwide. It also serves audiences beyond our targeted expert audience groups, giving an impact that is beyond traditional academic publishing. Both the website user stats and online information integration we have observed has indicated that our online audience engagement strategies have been successful, and highlights EuroGCT's critical role in disseminating reliable and accessible information about gene and cell therapies. Through our formal and informal stakeholder feedback mechanisms, we have received appreciation from a subset of our target audience as well as suggestions on areas that will benefit from further updates. We will continue to monitor and evaluate user feedback for our Research Pathways content and use this information for future reporting as well as to shape our audience engagement strategies.