FAST is excited to announce the upcoming release of the Guidebook for ATMP Development, a fundamental resource for developers—whether in academia or industry—engaged in conducting clinical trials or introducing advanced therapy medicinal products (ATMPs) to the Dutch market. This guide is designed to help developers navigate the complex European and Dutch ATMP landscape, offering deeper understanding of the required and optional steps at each stage of the development pathway. By providing clarity on the rules, regulations, and procedures, FAST aims to accelerate the development and access of these innovative therapies.

The value of ATMPs
ATMPs represent a emerging class of cutting-edge therapies that harness genes, tissues, and cells to restore, correct, or modify biological functions in patients. With the rapid advancements in this field, a significant number of new ATMPs are expected to reach the market in the coming years. These therapies often involve just one or two treatments and can provide curative or long-lasting effects, making them a game-changer in modern medicine, especially for complex and rare diseases.

Guidebook for developers
The Guidebook serves as a fundamental source for all developers who conduct ATMP clinical trials or aim to bring ATMPs on the Dutch market. It complements and is supportive to other initiatives like i.e. the Dutch infrastructure for cancer-specific ATMP Research (DARE-NL),  the IP toolbox of NFU – Dutch Association of University Medical centers and different tools from The Advanced Therapy Medicinal Products Patient and Public Involvement and Engagement Working Group (ATMP Engage).

Release in October

FAST plans to release the Guidebook for ATMP Development in October 2024.