National strategy for gene and cell therapies (GCT) handed over

SKC's founder and managing director, Prof. Matthias P. Schönermark M.D., Ph.D., was one of the 150 experts of the working group for a national strategy for GCT and contributed significantly to the development of the strategy.

"It was a great pleasure and honor to be able to participate in Working Group VII, which dealt with improving market access for gene and cell therapies. We developed concrete ideas on how market access for ATMPs in Germany can be directly facilitated and made internationally competitive. Let us hope that politicians will now react in a targeted manner." (Prof. Schönermark)

The national strategy for GCT strives for a holistic concept for the location Germany, which covers all parts of the value chain from basic research through to the provision of medical care. The primary goal is to ensure the well-being of patients, who are offered new perspectives through GCT focusing on serious diseases for which there are no effective treatment options available.

The strategy is focused on therapeutic approaches with advanced therapy medicinal products (ATMPs), therapeutic approaches with novel biological products (e.g. mRNA) and other approaches of this kind in the context of gene- and cell-based therapies. It comprises eight fields of action with strategic goals and concrete proposals for measures including the areas of

1. networking and stakeholder support,
2. training and strengthening expertise,
3. technology transfer,
4. standards and regulatory frameworks,
5. expansion of quality and capacities in the area of good manufacturing practice production,
6. research and development,
7. market authorisation and transition to supply as well as
8. interactions with society.

The measures are now to be implemented in collaboration with all stakeholders and will be subsidised by the federal and state governments over the next few years.

As Market Access Special Forces, SKC has already been able to support the German market access of 8 ATMPs in recent years. We welcome the proposals of the national strategy for gene and cell therapies and will continue to contribute to ensuring that patients with diseases for which there are no or only limited treatment options have access to effective treatment.

Source:

• Strategy paper