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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 89

Creating EU market access roadmaps for cell and gene therapies

  • UK
  • 2016
  • CGT Catapult
Market access roadmaps for cell and gene therapies published by Cell and Gene Therapy Catapult (CGT Catapult). Contains individual reimbursement roadmaps for UK (England and Wales), and EU countries (Spain, Italy, France, and Germany).

Theme

  • Show all 9
  • Funding
  • 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
  • Market access for ATMPs
  • Pricing & reimbursement

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.

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

Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

  • 2019
  • Frontiers in Pharmacology
This article reviews the legal frameworks in the EU and US for Advanced Therapy Medicinal Products (ATMPs), as well as the criteria to be met to define a product as such. The similarities and differences that exist between both regions are discussed in order to identify those nuances that may affect the development of an ATMP.

Theme

  • Show all 3
  • Legal classification
  • ATMPs
  • Market access for ATMPs

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.

Theme

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

EFPIA The root cause of unavailability and delay to innovative medicines

  • EU
  • 2023
  • EFPIA
Analysis by the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA's Root Causes Analysis identified 10 interrelated factors that were causing access to medicines to be delayed.

Theme

  • Show all 2
  • Market access for ATMPs
  • Pricing & reimbursement

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).

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

EMA Support for advanced therapy developers

  • EU
  • European Medicines Agency (EMA)
Advisory services and incentives the European Medicines Agency (EMA) offers for supporting the development of advanced therapy medicinal products (ATMPs).

Theme

  • Show all 7
  • Fundamental Research
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • ATMPs
  • Good Manufacturing Practice
  • Market access for ATMPs

The EBMT Handbook

  • EU
  • 2019
  • EBMT
The EBMT Handbook published by the European Society for Blood and Marrow Transplantation (EBMT) addresses the latest developments and innovations in haematopoietic stem cell transplantation (HSCT) and cellular therapy. It discusses all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, and also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies.

Theme

  • Show all 3
  • Fundamental Research
  • Clinical research
  • Ethics

The EBMT/EHA CAR-T Cell Handbook

  • EU
  • 2022
  • EBMT, EHA and Springer
This open access CAR-T Cell Handbook published by Springer and co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), provides an unparalleled overview of the CAR-T cell technology and covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues.

Theme

  • Show all 14
  • Fundamental Research
  • Clinical research
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement
  • Ethics

Orphanet: The portal for rare diseases and orphan drugs

  • Global
  • Orphanet
The Orphanet knowledgebase gathers and provides high-quality information on rare diseases for improving the diagnosis, care and treatment of patients with rare diseases.

Theme

  • Show all 7
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • ATMPs
  • Data storage
  • Data sharing / Open Data
  • Patient & Public Involvement
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