DARE-NL

To accelerate clinical testing of novel oncological ATMPs to ensure timely and sustainable access to potentially curative treatment options for cancer patients.

DARE-NL set-up

The Dutch platform for cancer-specific ATMP Research (DARE-NL) is a new partnership between all academic developers of Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. ATMPs, such as CAR T cells, are the next revolution in medicine promising a leap in survival, quality of life and cure for cancer patients. Although many novel ATMPs are under development in academic centers, the steps toward market approval and clinical application are complex and do not fit the traditional frameworks. The overarching goal of DARE-NL is to accelerate clinical testing of novel oncological ATMPs to ensure timely and sustainable access to potentially curative treatment options for cancer patients. To reach this goal, DARE-NL was funded by the Dutch Cancer Society (KWF) to establish a national infrastructure and connect all relevant stakeholders (e.g. scientists, clinicians, pharmacists, regulatory agencies, patient advocates) in the ATMP development cycle. Specifically, DARE-NL centralizes knowledge, harmonize protocols, provides raw materials, develops biologics and technologies, and facilitates implementation and patient outreach by:

Connecting

  • translational ATMP expertise in academic centers in the Netherlands
  • with policymakers and regulatory scientists in the Netherlands and the EU through centralized dialogues
  • with existing (inter)national ATMP oncology structures

Harmonizing

  • and exchanging procedures, QC protocols and processes
  • by mapping the need for translation of next-generation technologies in ATMP production

Facilitating

  • by establishing academic manufacturing of key good manufacturing practice (GMP) ingredients
  • by establishing an ATMP education program
  • by establishing a sustainable knowledge exchange platform

What is an ATMP?

Advanced Therapy Medicinal Products (ATMPs) are highly complex, labor-intensive and often personalized medicines in which genes, cells or tissues of a patient are (substantially) modified. Examples are cell-based therapies such as tumor infiltrating lymphocytes (TILs) and chimeric antigen receptor (CAR) T cell therapies. For these therapies living immune cells are obtained from the blood or bone marrow of a patient or donor. The cells are subsequently modified to exert a therapeutic effect in the patient, for instance by better locating or attacking cancer cells. Impressive long-term effects following CAR T cell or TIL therapy have been observed for cancer types and stages that did not respond to any other therapies.

Information on ATMPs available and in development in the Netherlands, webinars, trial registries and other information and education will follow soon.