Arrow Left Escher

Success and failure in the development and commercialization of ATMP products

Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Marketing Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle.

As part of the Escher platform for regulatory innovation, Lygature has started a project with the following objectives:

  • To conduct a cohort study that identify factors associated with the advancement of ATMPs through the medicines lifecycle. Factors that will be examined include product and developer characteristics, presence and use of regulations during development, and perceived uncertainties about ATMP development.
  • To conduct two small qualitative case studies that provide an in-depth exploration of two underlying factors that contribute to the advancement.

The research will be carried out together with the Utrecht University (UU) with the support of a research grant from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its specialized group European Biopharmaceutical Enterprises (EBE).

Share this pageā€¦