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Actors and Networks database

The evolving field of gene and cell therapy is supported by a large community of academic, clinical, translational, regulatory and patient organisations. The Actors and Networks database maps these stakeholders in Europe and beyond, their activities, and resources they have produced. 

EuroGCT has developed and compiled this database for those interested in identifying the actors involved at each stage of the pathways bringing gene and cell therapies from lab to clinic. Coming from an academic perspective, our focus is to map information that has not been mapped elsewhere. This includes documenting the various types of interconnected regulators, patient groups actively involved along the pathways, and non-profit organisations devoted to therapy development. In its first iteration, this database does not yet include commercial partners and service providers.

Additional complementary work by other organisations on GCT stakeholders mapping can be found here.

A scientific paper on actors has also been published in Humanities and Social Sciences Communications. You can find its lay summary here.

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European Union Intellectual Property Office (EUIPO)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Regulators
  • Patent Offices
  • Supranational Patent Offices

Development Stage:

  • Fundamental Research

Expert panels on medical devices (Expamed)

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Medical Device Authorities
  • Supranational Medical Device Authorities

Development Stage:

  • Clinical Research
  • Manufacturing
  • Commercialisation

Finnish Board for Gene Technology (Geenitekniikan lautakunta) (GTLK)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Finnish Coordinating Center for Health Technology Assessment (FinCCHTA)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Finnish Medicines Agency (Fimea)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • HTA Bodies
  • Medicines Agencies
  • National Medicines Agencies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Finnish Medicines Agency (Fimea) is the competent authority for tissues and cells and for blood and blood components in Finland.

Resources

Information for public: https://fimea.fi/en/for_public

Finnish National Committee on Medical Research Ethics (Valtakunnallinen lääketieteellinen tutkimuseettinen toimikunta) (TUKIJA)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Finnish National Supervisory Authority for Welfare and Health (Valvira)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Blood and Blood Components

Development Stage:

  • Manufacturing
  • Commercialisation

Finnish Patent and Registration Office (Patentti- ja rekisterihallitus) (PRH)

Region/Country:  
  • Countries in the EU/EEA
  • Finland

Type of Actor:

  • Regulators
  • Patent Offices
  • National Patent Offices

Development Stage:

  • Fundamental Research

Fondation de l’avenir

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Non-profit Research Organisations
  • Foundations

French Biomedicine Agency (Agence de la Biomédecine) (ABM)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components
  • Competent Authorities for Research
  • Research Funding Authorities
  • National Research Funding Authorities

Development Stage:

  • Fundamental Research
  • Translational Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The ABM receives applications for authorisation of embryo research, declarations of research on human embryonic stem cells and declarations of certain research on human induced pluripotent stem cells (those concerning differentiation into gametes, obtaining models of in vitro embryonic development, and the insertion of these cells into an animal embryo with the aim of transferring it to a female). It authorises the import and export of human embryonic stem cells. It issues opinions on clinical research involving its areas of competence. It is the competent authority for biovigilance. It is also in charge of promoting medical and scientific research on the regulated activities. To support financially studies and research projects, the Agency launches three calls a year. The themes of each of these calls for research proposals are defined by the medical and scientific committee and validated by the orientation council at the Agency. The allocated credits are integrated to the budget voted by the administrative council.
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