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Research Pathways

Development pathways for bringing gene and cell therapies from the lab to patients

Gene and cell therapies are evolving rapidly and show promise for treating many diseases and conditions. Hurdles remain in bringing safe, efficacious and high quality medicines based on genes, cells or tissues - Advanced Therapy Medicinal Products (ATMPs) - to patients in a timely manner.

EuroGCT aims to provide the research and regulatory communities with reliable and accessible information on the practical steps needed for gene and cell therapy development while promoting information exchange within and between these communities.

As this initiative develops, we begin with signposting to existing resources for guidance at each stage of development and will go on to fill information gaps identified in the field with expert-reviewed material. We hope to promote the free flow of knowledge to facilitate informed decision-making for researchers and regulators developing new therapies. 

Research and Innovation

The development of innovative therapies starts with translating discoveries from basic research. This section explores the steps from fundamental to pre-clinical and clinical research underpinning the development of innovative gene and cell therapies.

Therapy Classification

Therapy classification determines the legal mechanisms that govern the regulation of gene and cell therapies to ensure the quality, safety, and efficacy of these therapies on the EU market.

Manufacturing

Advanced therapy medicinal products (ATMP) manufacturing concerns the industry-scale production of these therapies for supporting clinical development and commercialisation. This section provides an overview of the ATMP manufacturing processes, key terms, and related resources.

Commercialisation

Enabling timely patient access to Advanced Therapy Medicinal Products (ATMPs), commercialisation covers marketing authorisation, and post-authorisation activities such as pharmacovigilance, pricing and reimbursement.
Commercialisation includes information on:

Actors and Networks  

The thriving field of gene and cell therapy is supported by a large community of academic, clinical, translational, industrial and patient organisations. This section maps the stakeholders and their activities in Europe and beyond.

Public Involvement  and Data

Developing gene and cell therapy involves people and their data. This section introduces best practices for public involvement and the handling of health data throughout the therapy development process.