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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 91
EuroGCT Resource

Human body elements for human applications

  • EU and UK
  • 2023
  • EuroGCT
Human body elements, including tissues, cells, blood and blood components can be used for therapeutic purposes in human recipients and extracorporal applications. Depending on the types of human body elements, they can be donated both or either by living or dead donors in accordance with national legislations.

Theme

  • Show all 2
  • Therapy classification
  • Not ATMPs: Human body elements for therapeutic applications
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

Theme

  • Show all 2
  • Research and Innovation
  • Clinical research
EuroGCT Resource

Support for innovative medicines’ development at the EMA level

  • EU and UK
  • 2023
  • EuroGCT
EMA's support for innovative medicines’ development aims to clarify the applicable regulatory requirements for the medicinal products in development. Both procedures and services support the developers through establishing best strategies as early as possible for obtaining the required data (robust quality, pre-clinical, and clinical data) for commercialising innovative medicinal products (including ATMPs) in the European Union (EU) through the applicable and most adapted regulatory pathway.

Theme

  • Show all 3
  • Research and Innovation
  • Early interaction with regulators
  • Market access for ATMPs
EuroGCT Resource

[Poster] The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools

  • EU and UK
  • 2023
  • EuroGCT
This poster provides an overview of the challenges of ATMPs’ manufacturing and link them to the relevant supporting regulatory tools highlighting both their strengths and their limits in the context of ATMPs development for patients.

Theme

  • Show all 2
  • Manufacturing Authorisation
  • Good Manufacturing Practice
EuroGCT Resource

[Poster] The marketing authorisation of advanced therapy medicinal products under the regulation of the European Union

  • EU and UK
  • 2023
  • EuroGCT
This poster presents the European regulatory requirements and pathways for ATMPs to obtain marketing authorisation, and discuss the challenges of their commercialisation.

Theme

  • Show all 2
  • ATMPs
  • Market access for ATMPs

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.

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.

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.

Theme

  • 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

Taking ATMPs to Market

  • UK
  • 2018
  • CGT Catapult
A presentation by Cell and Gene Catapult (CGT Catapult) on topics including: ATMP regulatory framework in EU, therapy classification, early development support by EMA (EU) and MHRA (UK), and market access pathways.

Theme

  • Show all 4
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • 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.

Theme

  • Show all 2
  • Clinical research
  • ATMPs
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