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Research Pathways

Bringing therapies from the lab bench to patients is a complex process. We are developing our own as well as signposting to existing resources to help guide researchers and those interested in therapy development through this process. 

The Research Pathways is centred around the legal and regulatory aspects that are required for cell and gene therapy development in Europe, from binding law, non-binding guidelines and recommendations, then further expanded to additional aspects including scientific developments, health economics and more. 

Learn more about Research Pathways

Additional navigation options

More ways to navigate Research Pathways

Key Pathways Resources

Signposting to key resources on ATMP development

Case Studies

Learn from specific development cases and relevant resources

Patient and Public Involvement

ATMP Engage Patient and Public Involvement Directory

Actors & Networks

Mapping the stakeholders in Europe and beyond
Showing 10 of 75

ARM Project A-Gene

  • Global
  • 2021
  • ARM
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) produced A-Gene, a case study-based guide to integrating Quality by design (QbD) principles in gene therapy Chemistry Manufacturing & Control (CMC) programs.

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs

ARM Project A-Cell

  • Global
  • 2022
  • ARM
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) produced A-Cell, a case study-based guide to integrating Quality by design (QbD) principles in cell therapy Chemistry Manufacturing & Control (CMC) programs. 

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs

ECRIN Paediatric Tools from the PedCRIN Project

  • EU
  • ECRIN
The PedCRIN Project by the European Clinical Research Infrastructure Network (ECRIN) has created a series of tools and procedures for training and supporting researchers and clinicians to establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective way.

Theme

  • Show all 1
  • Clinical research

EMA tools for academic medicine developers

  • EU
  • EMA
Regulatory and scientific support schemes by European Medicines Agency (EMA) for developers from the academic sector

Theme

  • Show all 6
  • Funding
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Market access for ATMPs
  • Pricing & reimbursement

ECRIN Rare Diseases Clinical Trials Toolbox

  • EU
  • ECRIN
The Rare Diseases Clinical Trials Toolbox by European Clinical Research Infrastructure Network (ECRIN) collects the accumulated knowledge, experience, and resources to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials, with a special focus on investigator-initiated trials for rare diseases. 

Theme

  • Show all 2
  • Clinical research
  • Ethics
EuroGCT Resource

Manufacturing Authorisation

  • EU and UK
  • 2023
  • EuroGCT
Any company wishing to manufacture a medicinal product must hold a manufacturing authorisation issued by the national competent authority of the Member State where they carry out these activities. To obtain a manufacturing authorisation, all medicinal products for human use intended for the European Union market must be produced in accordance with EU quality standards: Good Manufacturing Practice (GMP) principles and guidelines, and the European Pharmacopeia.

Theme

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

Data Protection Main Principles

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
The main principles of data protection include: Self-determination; Lawfulness, fairness and transparency; Purpose limitation; Data minimization; Accuracy; Storage duration limitation; Integrity, security and confidentiality; FAIR principles (findable, accessible, interoperable, reusable).

Theme

  • Show all 2
  • Data protection
  • Ethics

UKRI Health Funding Map

  • UK
  • UKRI and BIA
Health Funding Map developed by UK Research and Innovation (UKRI) Innovate UK KTN, the UK BioIndustry Association (BIA) and more funders. This interactive map helps the innovators to navigate the complicated world of health innovation funding across UK and EU.

Theme

  • Show all 1
  • Funding

About the PPI Directory

  • EU and UK
  • 2022
  • ATMP Engage
ATMP Engage Patient and Public Involvement (PPI) Directory contains PPI resources for developers of cell and gene therapies, including toolkits, guidelines, advice, templates and case studies.

Theme

  • Show all 1
  • Patient & Public Involvement

NIHR Clinical Trials Toolkit

  • UK
  • NIHR
The Clinical Trials interactive routemap by National Institute for Health Research (NIHR) is for helping users understand the UK Medicines for Human Use Regulations (Clinical Trials Regulations).

Theme

  • Show all 4
  • Clinical research
  • Translational Science
  • Pharmacovigilance
  • Ethics