What are ATMPs?

ATMP stands for Advanced Therapy Medicinal Product, which refers to a medicine made using advanced techniques. Techniques used include cell therapy and gene therapy. Genes or living cells are used to treat or prevent diseases. These medicines are often used to treat serious conditions where traditional treatments have proven ineffective. For example, ATMPs can be used to repair damaged tissues, correct genetic defects or strengthen the immune system. They are regarded promising for the treatment of rare diseases and other difficult-to-treat conditions such as cancer and autoimmune diseases. ATMPs are often custom-made using a patient’s own cells. Importantly, ATMPs have the potential to provide long-lasting effects with just one treatment.

Why is it difficult to get ATMPs to the patient?

Despite hopeful results from ATMP research, these medicines are not broadly administered yet. This is because the development of ATMP poses major challenges in many areas. Firstly, they are relatively new medicines whose effectiveness and safety are still extensively researched and continuously improved. In addition, complex laws and regulations apply to ATMP production, especially since each ATMP is unique. Since the developments around ATMPs are happening so quickly, regulations sometimes by definition are lagging behind. Furthermore, many different parties are involved in ATMP development, including researchers, physicians, pharmacists, regulators, reimbursement agencies, and more. This complicates the process.

What is DARE-NL doing to address this?

To better and faster get ATMPs to patients, all academic ATMP hospitals and research institutes combine their knowledge and expertise. They harmonize procedures and protocols and share knowledge, information and materials within the consortium to accelerate the development and production of ATMPs for the treatment of cancer. In addition, DARE-NL represents one voice towards regulatory and reimbursement bodies.