# Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways

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

► To cite this version:

Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, Clare Blackburn, et al.. Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways. European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom. halshs-03901227

HAL Id: halshs-03901227

https://shs.hal.science/halshs-03901227

Submitted on 15 Dec 2022

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# Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways

Auxane Delage<fnref n="1" />, Luc-Sylvain Gilbert², Hsin-Yu Kuo³, Jennifer Lorigan⁴, Clare Blackburn⁵, Anna Couturier⁶, Amanda Waite⁷, Aurélie Mahalatchimy⁸

## INTRODUCTION & AIM

Bringing gene and cell therapies from lab to patients raises challenges from the development of these therapies to patient access. Therapy development must comply with many regulatory requirements in order to ensure patient safety. These requirements have been established throughout the life cycle of these therapies from fundamental research to post-administration vigilance, through manufacturing, clinical trials, marketing authorisation, patentability, or pricing & reimbursement.

The EuroGCT website aims to provide accessible and reliable information on therapy development and regulatory pathways.

## METHODOLOGY

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Legal and scientific watch

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Collection and organisation of ATMPs legal acts and guidance

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Dissemination of information to EuroGCT partners

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Review of research pathways main entries drafts by partners & external collaborators

## GENERAL CHALLENGES RAISED & RESEARCH PATHWAYS TREE

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<footnote n="1">¹EuroGCT Information Officer on Ethical, Legal & Societal issues (ELSI), Research Engineer and PhD student in law, Law Faculty, UMR 7318 International, Comparative and European laws, UMR 7318 DICE CERIC, CNRS, Aix Marseille Univ., Toulon Univ., Aix-en-Provence, France;
²EuroGCT Information Officer on ELSI, Research Engineer in law, Law Faculty, UMR 7318 International, Comparative and European laws, UMR 7318 DICE CERIC, CNRS, Aix Marseille Univ., Toulon Univ., Aix-en-Provence, France; ³EuroGCT Information Officer on ATMP Product Development Pathway, Centre for Regenerative Medicine, Institute for Regeneration and Repair, Edinburgh univ., UK;
⁴EuroGCT Information Officer on Gene and Cell Therapy, Centre for Regenerative Medicine, Institute for Regeneration and Repair, Edinburgh univ., UK;
⁵EuroGCT Project Coordinator, Centre for Regenerative Medicine, Institute for Regeneration and Repair, Edinburgh univ., UK;
⁶EuroGCT Project Manager - Digital and Technical, Centre for Regenerative Medicine, Institute for Regeneration and Repair, Edinburgh univ., UK;
⁷EuroGCT Project Manager - Information and Networks, Centre for Regenerative Medicine, Institute for Regeneration and Repair, Edinburgh univ., UK;
⁸EuroGCT Deputy coordinator and WP4 leader, Permanent Researcher in law at the French National Centre for Scientific Research (CNRS, CR), Law Faculty, UMR 7318 International, Comparative and European laws, UMR 7318 DICE CERIC, CNRS, Aix Marseille Univ., Toulon Univ., Aix-en-Provence, France. Acknowledgement: This work has been supported by Horizon 2020 funded EuroGCT project (GA N° 965241, PI: C. Blackburn).</footnote>