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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 86

Responsible personalised medicine: Exploring the ethical, legal, social, political and economic issues of manufacturing, distribution, access and reimbursement.

  • UK
  • 2022
  • UCL Future Targeted Healthcare Manufacturing Hub
A report published by University College London (UCL) Future Targeted Healthcare Manufacturing Hub provides an overview of the ethical, legal, social, political and economic issues underpinning the “manufacturing, business and regulatory challenges” that confront the development and delivery of affordable and accessible personalised medicines.

Theme

  • Show all 6
  • Manufacturing
  • Market access for ATMPs
  • Distribution
  • Pricing & reimbursement
  • Data protection
  • Ethics

Cost and availability of novel cell and gene therapies

  • 2023
  • EMBO Reports
Advanced gene and cellular therapies risk a second “valley of death” due to their high costs and low patient population. As these are life-saving therapies, measures are urgently needed to prevent their withdrawal from the market.

Theme

  • Show all 2
  • ATMPs
  • Pricing & reimbursement

WHO Human Genome Editing (HGE) Registry

  • Global
  • WHO
The World Health Organization (WHO) Human Genome Editing (HGE) Registry is a central database that collects information of clinical trials using human genome editing technologies.

Theme

  • Show all 2
  • Clinical research
  • Data storage

ECRIN CAMPUS for Regulatory and Ethical Requirements

  • EU
  • ECRIN
The Regulatory and Ethical Tool (CAMPUS) by the European Clinical Research Infrastructure Network (ECRIN) is a central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types.

Theme

  • Show all 2
  • Clinical research
  • Ethics

ATMP Sweden Regulatory Guide

  • Sweden
  • ATMP Sweden
ATMP Sweden's regulatory guide for the development of the Advanced Therapy Medicinal Products (ATMPs)

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling

ABPI ATMP Roadmap

  • UK
  • 2021
  • ABPI
The Association of the British Pharmaceutical Industry (ABPI) has developed an ATMP roadmap which sets out the key steps in the end-to-end pathway for ATMPs in UK, from non-clinical research through patient treatment and monitoring.

Theme

  • Show all 15
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement
  • Data storage

NCATS PaVe-GT: Paving the Way for Rare Disease Gene Therapies

  • USA
  • NCATS
The Platform Vector Gene Therapy (PaVe-GT) pilot project lead by National Center for Advancing Translational Sciences (NCATS) at National Institutes of Health (NIH) seeks to increase the efficiency of clinical trial startup by using the same gene delivery system and manufacturing methods for multiple rare disease gene therapies.

Theme

  • Show all 9
  • Fundamental Research
  • Clinical research
  • Translational Science
  • ATMPs
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability

ABPI Bridging between pre- and clinical boundary

  • United Kingdom
  • 2018
  • The Association of the British Pharmaceutical Industry (ABPI)
A report for a joint workshop held by the Academy of Medical Sciences and the Association of the British Pharmaceutical Industry (ABPI). The meeting looked to identify challenges, gaps, and opportunities for greater integration of pre-clinical and clinical science, and the vision for the future of translational research in the UK.

Theme

  • Show all 4
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding

Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap

  • 2017
  • Therapeutic Innovation & Regulatory Science
A practical roadmap for Patient Involvement (PI) opportunities along the 4 key stages of the medicines R&D life cycle.

Theme

  • Show all 1
  • Patient & Public Involvement

EMA pilot programme

  • EU
  • 2022
  • EMA
European Medicines Agency (EMA) pilot program on enhanced regulatory support for academic and non-profit ATMP developers

Theme

  • Show all 5
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Market access for ATMPs
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