Increasing ATMP regulatory awareness in producers and ATMP acceptance in patients and healthcare professionals

Advanced Therapy Medicinal Products (ATMPs) are medicines based on genes, cells and tissues. While they are promising, there are many challenges associated with the development and market access of these advanced medicines. This doctoral project is part of a European project called JOIN4ATMP, led by the European University Hospital Alliance (EUHA), an alliance of the largest university hospitals in 10 European countries. This doctoral project will focus on several topics within the entire supply chain of ATMPs, from development to market access and pricing. Specific topics to be investigated include early interactions between ATMP developers and regulatory agencies, the possibility of setting up a platform for information and expertise exchange, the use of real-world data (RWD) in pricing and reimbursement of ATMPs, and patients' perceptions of ATMPs. A range of research methods will be employed, including literature reviews, semi-structured interviews, and the organisation of stakeholder workshops.