Advanced Therapy Medicinal Products (ATMP) in Sweden – possibilities and challenges

This presentation focuses on AI, digitization, and their impact on healthcare, with a strong emphasis on patient-centered approaches. Participants will gain insights into Advanced Medicinal Therapeutic Products (ATMPs), covering their development and the challenges they face. ATMPs, including biological drugs, cells, tissues, and gene therapies, represent innovative treatments but encounter significant regulatory, manufacturing, and logistical hurdles.

Gene therapies can be Ex Vivo Gene Therapy Medicinal Product (GTMP), where cells are modified outside the body, or In Vivo GTMP, where genes are directly delivered to the patient. Despite their potential, ATMPs face challenges such as high costs, complex regulations, and the need for scalable manufacturing processes. In Sweden, initiatives like the CCRM Nordic hub and ATMP Sweden are addressing these issues by fostering collaboration among hospitals, academia, and industry. The goal is to enhance ATMP development and implementation capacity, ensuring these advanced therapies benefit more patients while navigating the intricate landscape of regulations and healthcare logistics.