# Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org

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

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Aurélie Mahalatchimy, Hsin-Yu Kuo, Valentin Roby, Luc-Sylvain Gilbert, Auxane Delage, et al.. Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org. EuroGCT. 2026. halshs-05500173

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Submitted on 9 Feb 2026

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# Deliverable Report

**Grant Agreement Number: 965241**

**Project acronym: EuroGCT**

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

**Deliverable: D4.5 Knowledge-sharing function**

**Report on development of a knowledge-sharing function within**
**www.eurogct.org**

**Date: 31st Jan 2026**
<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><a href="http://www.eurogct.org">www.eurogct.org</a></td></tr><tr><td colspan="2"><strong>Document</strong></td></tr><tr><td>Deliverable number:</td><td>D.4.5</td></tr><tr><td>Deliverable title:</td><td>Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org</td></tr><tr><td>Due date of deliverable:</td><td>Month 60</td></tr><tr><td>Associated Milestones</td><td>NA</td></tr><tr><td>Actual submission date:</td><td>31 Jan 2026</td></tr><tr><td>Last Editor:</td><td>Hsin-Yu KUO</td></tr><tr><td>Contributors:</td><td>Aurélie MAHALATCHIMY, Hsin-Yu KUO, Valentin ROBY, Luc- Sylvain GILBERT, Auxane DELAGE, Clare Blackburn</td></tr><tr><td>Work Package no.:</td><td>4</td></tr><tr><td>Work Package title:</td><td>An Information and Engagement Hub for the Research and Regulatory Communities</td></tr><tr><td>Work Package lead beneficiary:</td><td>2-AMU</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>10</td></tr></table>
## Table of Contents

<table><tr><td>Deliverable Report</td><td>1</td></tr><tr><td>D4.5 Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org</td><td>5</td></tr><tr><td>1 Introduction</td><td>5</td></tr><tr><td>2 Knowledge-sharing functions and activities</td><td>5</td></tr><tr><td>Through developing, reviewing, updating and translating EuroGCT's key resources</td><td>6</td></tr><tr><td>Through developing case studies</td><td>8</td></tr><tr><td>Through identifying and signposting to high quality resources</td><td>8</td></tr><tr><td>Through identifying actors in the GCT field</td><td>9</td></tr><tr><td>Through sharing presentation material from conferences and meetings</td><td>9</td></tr><tr><td>Through co-developing Patient and Public Involvement (PPI) directory</td><td>9</td></tr><tr><td>Through dedicated EuroGCT key resources and sections of EuroGCT key resources on interactions with regulators</td><td>9</td></tr><tr><td>3 Conclusion</td><td>10</td></tr></table>
List of acronyms

**ATMP:** Advanced Therapy Medicinal Products

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

**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)

**ELSI:** Ethical, Legal and Societal Issues

**NoE:** Gene and Cell Therapy Network of Expertise

**WP:** Work Package

**MG:** Management Group
# D4.5 Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org

## 1 Introduction

Work package 4 (WP4), entitled "An Information and Engagement Hub for the Research and Regulatory Communities", is focussed on development of an information hub 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 creates 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. WP4 also promotes liaison between cell and gene-based therapy stakeholders and the regulatory agencies.

**Deliverable 4.5** reports on Task 6, Creation of an online space to promote knowledge sharing among stakeholders. This report provides a summary of all information-sharing functions built on the EuroGCT website, and how the consortium and the wider gene and cell therapy (GCT) communities have been using these functions to date.

## 2 Knowledge-sharing functions and activities

From the beginning of the project, the consortium has opted for transparency (i.e. not having a member-only area on the website) around GCT product development pathways, and at the same time, aimed for making this scientific information accessible for non-specialist stakeholders involved in product-development-related decision-making. The detail of this discussion has been documented in the management group (MG) meeting minutes, and is available by request. To make the scientific information accessible, members of the MG has suggested not to 'dumb down', but rather, to provide layers of increasing detail. The MG has underlined the importance of keeping the information about GCT product development transparent and accessible, given the widespread misinformation and unproven treatments in this area.

Knowledge-sharing functions and activities have been conducted both in person and online. In person, EuroGCT has created discussion spaces for knowledge-sharing on targeted topics through the organising regulatory workshops (on ATMP based on genetically modified organisms at ESGCT 2023, on policy and regulatory strategies at ESGCT 2025, on ATMP and Health Technology Assessment at Building Medicines Justice Conference in 2025) and through participating in conferences, workshops, and meetings for face-to-face direct information exchanges. (See dissemination activities in D2.2, D6.3 and more will be reported in D4.6 due at month 64.)

Online, which is the focus of this deliverable, the Research Pathways section on the website covers information on product development, especially on ATMPs, from fundamental research to patient access (lab to patient), their technical and ethical, legal and societal Issues (ELSI) aspects. All website features within this section that are supporting the open knowledge-
sharing have been reported in D4.1 and D4.3 previously. Below, we provide the detail of the
different ways the consortium partners, the EuroGCT Network of Expertise (NoE) and the
EuroGCT Translator Network have been using these features to share information with the
wider European GCT communities.

Through developing, reviewing, updating and translating EuroGCT's key
resources

As described in **D4.1 and D4.8**, the knowledge-sharing among the consortium partners and the NoE mainly focussed on completing all entries curated within the [EuroGCT Key Resources](https://www.eurogct.org/research-pathways) section. The actions taken by the community members include drafting the written content, identifying relevant EU legislation, European guidance, and national laws (when possible), and journal articles for linking to, as well as reviewing and updating the content. Significant amount of work has also been put into the understanding and clarification of the evolution of the relevant legislations (e.g. the new SOHO Regulation, the proposed new medicinal products Directive and more) in order to provide review and update at relevant time.

In addition to those reported in D4.1 and D2.9, The following entries have been completed,
reviewed and published during the current reporting period:

* Manufacturing & Controls for Advanced Therapy Medical Products (https://www.eurogct.org/research-pathways/research-and-innovation/fundamental-research/manufacturing-phase/manufacturing)

* Non-clinical models for Cell & Gene Therapies (https://www.eurogct.org/research-pathways/research-and-innovation/fundamental-research/non-clinical-models-cell-gene)

* Support from several competent authorities for the development of innovative medicines (https://www.eurogct.org/research-pathways/research-and-innovation/early-interactions-regulators/support-innovative-2)

* Policy and regulatory strategies: current and prospective impact on gene and cell therapy development (https://www.eurogct.org/policy-and-regulatory-strategies-current-and-prospective-impact-gene-and-cell-therapy-development)

* Pricing and reimbursement (https://www.eurogct.org/research-pathways/commercialisation/pricing-and-reimbursement)

As described in D2.9, 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 outside of the version in English. This work has been done through involving
the NoE and the Translator Network for developing resources in French and Italian. In the
current reporting period, WP4 has additionally published the following entries in French and
Italian language:

In French: (see them at https://www.eurogct.org/fr/research-pathways)

* Manufacturing & Controls for Advanced Therapy Medical Products

* Actors and Networks database

* Policy and regulatory strategies: current and prospective impact on gene and cell therapy development
* How to use Research Pathways

* About EuroGCT's Key Resources

* Who should use EuroGCT's key resources, and how to use them?

* Relevant Literature section of EuroGCT's key resources

* Research and Innovation

* Non-clinical models for Cell & Gene Therapies

* Early interactions with regulators

* Support for innovative medicines' development

* Support for innovative medicines' development at the EMA level

* Support specific to ATMPs' development at EMA level

* Therapy Classification

* ATMPs: Applicable regulatory pathways

* CAT scientific recommendations on classification

* ATMPs and Orphan medicines

* ATMPs specific "Hospital exemption" pathway

* "Compassionate use" and "named-patients basis" pathways for ATMPs

* Manufacturing

* Good Manufacturing Practice for ATMPs

* Commercialisation

* Advertising of ATMPs

* Public Involvement and Data

In Italian: (see them at https://www.eurogct.org/it/node/557)

* How to use Research Pathways

* About EuroGCT's Key Resources

* Who should use EuroGCT's key resources, and how to use them?

* Relevant Literature section of EuroGCT's key resources

* EuroGCT Key Resources

* Research and Innovation

* Non-clinical models for Cell & Gene Therapies

* Manufacturing & Controls for Advanced Therapy Medical Products

* Translational Science

* Early interactions with regulators

* Support for innovative medicines' development

* Support for innovative medicines' development at the EMA level

* Support specific to ATMPs' development at EMA level

* Therapy Classification

* ATMPs: Applicable regulatory pathways

* CAT scientific recommendations on classification

* ATMPs specific "Hospital exemption" pathway

* "Compassionate use" and "named-patients basis" pathways for ATMPs

* Manufacturing

* Manufacturing Authorisation of ATMPs

* Good Manufacturing Practice for ATMPs

* Packaging and labelling of ATMPs

* Commercialisation
* Market Access for ATMPs

* Standard Marketing Authorisation Pathway: Centralised Procedure for ATMPs

* Marketing Authorisation Application file for ATMPs

* Conditional Marketing Authorisation of ATMPs

* Marketing Authorisation under exceptional circumstances for ATMPs

* Advertising of ATMPs

* Public Involvement and Data

* Data

* Data protection

* Data Classification

* Data Protection Main Principles

* Data Protection Authorities

* Data collection, processing, controlling

* Data sharing / Open data

* Mission creep / Data misuse

* Actors and Networks database

* Policy and regulatory strategies: current and prospective impact on gene and cell therapy development

* Pricing and reimbursement

## Through developing case studies

Partners and the wider community share their learnings regarding to the development path of an ATMP, or learnings at a specific moment.

Our case study content type (see D4.1) collates existing resources including research articles, review articles, interviews, news articles, EMA authorisation details, HTA appraisals and more related to the development of authorised ATMPs in addition to links to the relevant sections of the Research Pathways. At the time of writing, three case studies have been published: 1) Holoclar, a Tissue Engineered Product (TEP), and 2) Strimvelis, a Gene Therapy Medicinal Product (GTMP) and 3) considerations in therapy classification. These case studies serve as a guide for the research community to learn about the development process, the keys to success, the challenges and specific aspects to consider with regards to therapy classification. Additional case studies are in development and are anticipated to be published within the next few months.

## Through identifying and signposting to high quality resources

Knowledge-sharing is achieved by signposting to identified high quality resources. The Research Pathways section curates the resources that concerns product development, and the ATMP Engage PPI directory curates those for patient and public involvement resources.

As reported in D4.1, consortium partners flag resources produced by their organisations, or provide suggestions for information that are useful in their own research and development activities. Resources suggested by this route are then assessed, and promoted through links in the Research Pathways section.
Through our dissemination and networking activities reported in D2.4 and D6.3, we have connected with a number of organisations and projects external to EuroGCT. Leveraging these organisations' expert insight, we have identified relevant resources produced by them or others, and the resources are then indexed and signposted from the Research Pathways section.

## Through identifying actors in the GCT field

Consortium partners help identify key actors in the GCT field, and help populating the Actors and Networks database by providing the actors' information. Therefore, the knowledge of who contributes and what the contributions are in the GCT field can be shared among all stakeholders. (See D4.3 for more details)

## Through sharing presentation material from conferences and meetings

Knowledge-sharing is also achieved by sharing information presented in conferences and meetings. For example, EuroGCT hosted a workshop on policies and national strategies in EU nations during ESGCT 2025 Seville. Agreed by the speakers, their presentation slides presented during the meeting are shared with the wider communities through relevant sections in Research Pathways: Policy and regulatory strategies: current and prospective impact on gene and cell therapy development (https://www.eurogct.org/policy-and-regulatory-strategies-current-and-prospective-impact-gene-and-cell-therapy-development). Similarly, another workshop recently EuroGCT hosted on exploring the challenges of enabling equitable patient access to Advanced Therapy Medicinal Products (ATMPs) in the EU has the presentation material uploaded and shared through EuroGCT's website, and can be accessed at: Pricing and reimbursement (https://www.eurogct.org/research-pathways/commercialisation/pricing-and-reimbursement). Posters with summarised information previously presented at conferences have also been indexed and curated in Research Pathways. These poster resources can be accessed through selecting the filter category "presentation slides/posters" within Resource Type on the Research Pathways (https://www.eurogct.org/research-pathways) search page.

## Through co-developing Patient and Public Involvement (PPI) directory

As reported in D4.1, EuroGCT co-developed and hosts the ATMP Engage PPI Directory (https://www.eurogct.org/ppi-directory) which contains indexed patient and public involvement (PPI) resources for developers of cell and gene therapies. The curated resources span EU and UK and are applicable to users independent of their geographical locations. Consortium partners shares their knowledge on PPI by flagging PPI resources to the EuroGCT IMHT for indexing and curation.

## Through dedicated EuroGCT key resources and sections of EuroGCT key resources on interactions with regulators

As reported in D4.4, the EuroGCT Regulator Engagement Strategy has been adapted in order to tackle one of the main challenges regarding the communication on regulatory aspects of gene and cell therapy -- the lack of knowledge of existing tools in order to interact with
regulators in a wide meaning. Thus, a paragraph on "interactions with regulators" has been included in each EuroGCT key resources. Moreover, EuroGCT key resources targeting interactions with medicines agencies in particular (especially EMA and National medicines agencies) have been created. They include an introduction on Early interactions with regulators (https://www.eurogct.org/research-pathways/research-and-innovation/early-interactions-regulators) linking to the following sub-entries:

* Support for innovative medicines' development at the EMA level (https://www.eurogct.org/research-pathways/research-and-innovation/early-interactions-regulators/support-innovative-0)

* Support from several competent authorities for the development of innovative medicines (https://www.eurogct.org/research-pathways/research-and-innovation/early-interactions-regulators/support-innovative-2)

* Support specific to ATMPs' development at EMA level (https://www.eurogct.org/research-pathways/research-and-innovation/early-interactions-regulators/support-specific-atmps)

These are online tools for stakeholders to know about and use in practice. These resources uncover and explain the existing mechanisms for sharing knowledge with regulators with an aim to successfully bring gene and cell therapy to patients.

## 3 Conclusion

A wide range of features on EuroGCT website's Research Pathways section has been built to facilitate open knowledge sharing. With these website features, the knowledge-sharing among the consortium partners, NoE members and EuroGCT Translator network has been achieved through:

1. developing, reviewing and translating EuroGCT original resources

2. developing case studies

3. identifying and signposting to high quality resources

4. identifying actors in the GCT field

5. sharing presentation material from conferences and meetings

6. co-developing and hosting the Patient and Public Involvement (PPI) directory

7. dedicated EuroGCT key resources and sections of EuroGCT key resources on interactions with regulators

These online knowledge sharing activities resulted in a catalogue of resources mounted on the Research Pathways Information Hub, ensuring the GCT and wider communities can freely access the high-quality information they need throughout the product development processes. It provides a 'one-stop-shop' for these communities and is anticipated to play a significant role in improving product development.