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Adeno-associated virus (AAV)
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Research Pathways

Bringing gene and cell therapies from the lab bench to patients is a complex process and multiple pathways exists. The Research Pathways directory contains resources to help various stakeholders interested in therapy development navigate this process. Research Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in Europe and further expanded to additional aspects. It is free to use and all resources in this database are categorised for improved searchability.

How to use Research Pathways  EuroGCT's Key Resources

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Showing 10 of 34
EuroGCT Resource

Case Study: Early therapy classification considerations in developing skin equivalents

  • EU and UK
  • 2024
  • EuroGCT
How a therapy is developed and produced can affect its classification and determines the legal mechanisms that govern its regulation. In the case of developing skin equivalents for healing skin wounds, choices of preparation steps results in different therapy classification.
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Theme

  • Show all 10
  • Fundamental Research
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Good Manufacturing Practice
  • Market access for ATMPs
  • Pharmacovigilance
EuroGCT Resource

Clinical trials

  • EU and UK
  • 2023
  • EuroGCT
Clinical trials are a type of clinical studies performed to investigate the safety and/or the efficacy of a medicinal product
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  • Research and Innovation
  • Clinical research

Manufacturing process development of ATMPs within a regulatory framework for EU clinical trial & marketing authorisation applications

  • 2016
  • Cell And Gene Therapy Insights
In the European Union, the regulatory approval of ATMPs for use in patients requires that data demonstrating their quality, safety and efficacy are submitted in dossiers to regulatory agencies for review. Indeed, such dossiers have a specific format that, in the case of quality data in particular, is informative for the manufacturing process development strategy. This manuscript describes how dossier requirements can be implemented into the design of industrialized ATMP manufacturing processes and fulfilled to enable effective regulatory submissions.
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Theme

  • Show all 10
  • Clinical research
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
EuroGCT Resource

Case Study: Strimvelis

  • EU and UK
  • 2023
  • EuroGCT
Case Study on Strimvelis: Strimvelis is the first ex vivo gene therapy to be licensed, and its success is the result of a joint effort among different stakeholders. Here we collated existing information about each stage of its development as a guide for the research community to learn about its development process.
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Theme

  • Show all 13
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Market access for ATMPs
  • Pharmacovigilance
  • Pricing & reimbursement
  • Data
  • Data protection
  • Data storage
  • Data collection, processing, controlling
  • Data sharing / Open Data
  • Mission creep / data misuse
EuroGCT Resource

Case Study: Holoclar

  • EU and UK
  • 2023
  • EuroGCT
Case Study on Holoclar: Holoclar is one of the few ATMPs that have been granted marketing authorisation in Europe. We collated existing information about each stage of development for Holoclar, from early-stage research to approval, for the research community to learn about its development process.
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  • Show all 18
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Commercialisation
  • Market access for ATMPs

Overview of current GMO regulatory landscape

  • UK
  • 2023
  • CGT Catapult
An on-demand webinar by the Cell and Gene Therapy Catapult (CGT Catapult) on the current GMO regulatory landscape in EU and UK.
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  • Show all 2
  • Clinical research
  • ATMPs

Viral vectors-what are the solutions to current scale up challenges?

  • UK
  • 2019
  • CGT Catapult
A presentation by Cell and Gene Therapy Catapult (CGT Catapult) on the current state, barriers, and solutions to challenges in viral vector manufacturing
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Theme

  • Show all 5
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Capability
  • Scalability

New guidance on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape

  • UK
  • 2022
  • CGT Catapult
A guidance by the Cell and Gene Therapy Catapult (CGT Catapult) on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape.
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Theme

  • Show all 15
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Packaging and labelling
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

  • 2019
  • Molecular Therapy - Methods & Clinical Development
Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission. This review discusses how the regulatory pathway for any particular ATMP, with or without PRIME designation, is determined and navigated.
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Theme

  • Show all 7
  • Clinical research
  • Translational Science
  • Legal classification
  • ATMPs
  • Good Manufacturing Practice
  • Market access for ATMPs
  • Pharmacovigilance

EMA Guidelines relevant for advanced therapy medicinal products

  • EU
  • European Medicines Agency (EMA)
Scientific guidelines developed by The European Medicines Agency (EMA) relevant for Advanced Therapy Medicinal Products (ATMPs).
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Theme

  • Show all 13
  • Fundamental Research
  • Clinical research
  • Translational Science
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
  • Pharmacovigilance
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