From Research to Patient Care: Germany’s Strategy for Gene and Cell-Based Therapies
A new publication in the journal Human Gene Therapy outlines how Germany’s National Strategy for Gene- and Cell-Based Therapies aims to accelerate the translation of scientific discoveries into clinical applications. Prof. Dr. Sven Stegemann, CEO of the fiT – Leibniz Joint Lab First in Translation at DWI, contributed to both the strategy and the publication.
Gene- and cell-based therapies are opening up new treatment options for severe diseases, including conditions for which no effective therapies are currently available. However, turning a promising discovery into a treatment that can be used in clinical practice remains a complex process. Scientific development, regulation, manufacturing, financing and patient access must all be considered from an early stage. The new publication, The German National Strategy for Gene- and Cell-Based Therapies: Generating Impact by Employing a Novel Multi-Stakeholder Approach, describes how the National Strategy addresses these challenges. More than 150 experts from academia, healthcare, industry, politics, professional associations and patient organizations contributed to its development in eight working groups.
Prof. Dr. Sven Stegemann, CEO of the fiT – Leibniz Joint Lab First in Translation, is one of the publication’s authors. He contributed to the strategy as spokesperson for the working group on quality and capacity in Good Manufacturing Practice (GMP) production and as a member of the working group on technology transfer.
Both areas are crucial for successful translation. New therapeutic approaches can only reach clinical trials and ultimately patients if they can be manufactured safely, reproducibly and according to strict quality standards. At the same time, effective technology transfer is needed to turn academic research into viable medical products.
The publication also presents measures that are already being implemented, including new networking and information platforms, regulatory support, funding and entrepreneurship programs, and the expansion of translational infrastructure. These efforts closely align with the mission of fiT: supporting researchers in systematically advancing biomedical discoveries towards clinical application.
Publication:
Gallus et al., The German National Strategy for Gene- and Cell-Based Therapies: Generating Impact by Employing a Novel Multi-Stakeholder Approach, Human Gene Therapy (2026)