With recent developments in innovative technologies, new opportunities arise to address demands of an aging population, as well as for diseases with high unmet medical needs.
Since 2007 Advanced Therapy Medicinal Products (ATMPs) are specifically regulated in the EU. ATMPs are medicinal products including gene therapies, somatic cell therapies and tissue engineered products.
So far, a small number of ATMPs have been approved in the European Union despite considerable development activity in this field. Also, there is a very limited knowledge on the evolution of the ATMP field in the EU, the specific factors that are associated with the advancement of ATMPs through the medicines life-cycle and on how uncertainties about ATMP development impact upon life-cycle development.
Lygature (formerly TI Pharma) is a Dutch not-for-profit foundation that acts as a catalyst for the development of new medical solutions for patients by driving public-private collaboration between academia, industry and society.
Lygature is providing a platform for regulatory innovation (“Escher”) aimed at identifying areas for potential improvement within the EU regulatory system that will positively affect innovative research and development, and the development of products that address medical need/priority medicines.
The European Biopharmaceutical Enterprises (EBE), together with EFPIA ( European Federation of Pharmacetical Industries and Associations (EFPIA) and the Utrecht University (UU) will support Lygature’s project to examine factors associated with successful ATMP development and commercialization in Europe using a mixed quantitative – qualitative approach.
Lygature will deliver a report containing a detailed description of the conducted empirical research as well as a number of high-level recommendations for directions that the regulatory system can take with regard to ATMPs and how regulatory science can contribute to this.