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From the beginning, the strategy was meant to be developed across multiple perspectives by actively involving all relevant stakeholders. These stakeholders include experts from science, business, politics, society, as well as authorities, foundations, and patient organizations. 

An initial proposal of the necessary framework conditions and proposals for relevant fields of action was drawn up by the BIH in collaboration with the German Society for Gene Therapy (DG-GT) and the German Stem Cell Network (GSCN). In the following months, these fields have iteratively been developed further through various public workshops at industry conferences and have been finalized at a stakeholder round table to cover eight fields of action:

I. Stakeholder Networking and Support

II. Training and Development of Skills

III. Technology Transfer

IV. Standards, Norms and Regulatory Framework

V. Increase of Quality and Capacities for GMP Production

VI. Research and Development

VII. Marketing Authorization and Use in Patient Care

VII. Interaction with Society

Between October 2023 and May 2024, around 150 representatives of the various stakeholders jointly developed the document on the National Strategy for Gene- and Cell-Based Therapies in eight working groups with organizational support from the BIH.

On June 12, 2024, the strategy paper will be handed over to the Federal Minister of Education and Research, Bettina Stark-Watzinger, at the Futurium Berlin. 

The event is open to the public. All interested parties are invited to register here.

As part of the development of the strategy, a national network office for gene and cell therapies has already been established in parallel. Its mission is to build a national GCT community that includes all stakeholder groups through independent, cross-site information and networking. 

Further information on the National Network Office can be found here.