Research Pathways

Bringing therapies from the lab bench to patients is a complex process. We've compiled resources and signposting to help guide through the development process - from legal regulations to best practices.

Find here information and resources for researchers, regulators, and those interested in therapy development.

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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

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Showing 10 of 54

EMA pilot programme

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

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

Data sharing / Open data

  • EU
  • 2023
  • Inserm, University of Toulouse Paul Sabatier and EuroGCT
Data sharing is the act of providing data or access to data from a data holder to a data user, for a defined processing purpose, subject to applicable technical, financial, legal, or organisational use requirements. Open data refers to making available research data or publications without restrictions regarding the reuses.
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Theme

  • Show all 2
  • Data sharing, Open Data
  • Ethics

Data collection, processing, controlling

  • EU
  • 2023
  • Inserm, University of Toulouse Paul Sabatier and EuroGCT
Health data collection, processing, controlling: as health data reveal sensitive information about the individuals concerned, their use is strictly regulated so as not to infringe the rights and freedoms of the data subjects
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Theme

  • Show all 2
  • Data acquisition, processing, controlling
  • Ethics

Data Protection Authorities

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
Data protection authorities can be categorised into three levels: European Union (EU) level (the European Data Protection Board), National level (the national data protection authorities, designated by the European Union’s General Data Protection Regulation (GDPR) as ‘supervisory authorities’) and Regional level (some countries have regional data protection authorities)
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Theme

  • Show all 1
  • 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).
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Theme

  • Show all 2
  • Data protection
  • Ethics

Data Classification

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
Non personal data, personal data, and more specifically sensitive data such as genetic or health data, as well as electronic health data may be used during the development of gene and cell therapies. Data classification, the nature of the type of data in question, determines the applicable legal norms.
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Theme

  • Show all 1
  • Data protection

Translational Science

  • EU and UK
  • 2023
  • EuroGCT
Translational science translates basic science discoveries into therapeutic applications.
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Theme

  • Show all 2
  • Research and Innovation
  • Translational Science

Case Studies

  • EU and UK
  • EuroGCT
The Research Pathways case studies landing page
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Theme

  • Show all 33
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Intellectual Property rights
  • Early interaction with regulators
  • Therapy classification
  • Legal classification
  • ATMPS
  • Not ATMPs: Human body elements for the therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
  • Not ATMPs: other
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • European Pharmacopeia
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Advertising
  • Pharmacovigilance
  • Pricing & reimbursement
  • Data
  • Data protection
  • Data collection and storage
  • Data acquisition, processing, controlling
  • Data sharing, Open Data
  • Mission creep, data misuse

Accelerated Assessment 

  • EU and UK
  • 2023
  • EuroGCT
To facilitate early patient access to medicinal products, marketing authorisation (MA) can be granted through specific regulatory mechanisms offered by European Union law. The accelerated assessment is a procedural tool to reduce the centralised procedure review period of a marketing authorisation applicant. An applicant may request an accelerated assessment for medicinal products if they are of major public health interest, in particular from the viewpoint of therapeutic innovation.
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Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs

Marketing Authorisation under exceptional circumstances 

  • EU and UK
  • 2023
  • EuroGCT
To facilitate early patient access to medicinal products, marketing authorisation (MA) can be granted through specific regulatory mechanisms offered by European Union law. A marketing authorisation under exceptional circumstances for medicinal products may be granted when the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indication to be treated is too rare, the present state of scientific knowledge is insufficient to provide comprehensive information, or it would be unethical to collect this information.
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Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
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