PROMOS includes several key activities aimed at facilitating the translation of research findings into the clinics.
What are the main regulatory barriers to be faced by researchers? Are there major differences in the regulation to be followed by advanced therapies in the Italy-Austria cross-border area? What strategy of actions could simplify the regulatory aspect, thereby fostering a more collaborative cross-border environment?
By combining the scientific interest and expertise of project partners and the experience in regulatory aspects of the firm T&B Associati, PROMOS concretely analyzed the state-of-the-art in the use of adipose tissue-derived cells for wound healing with the goal of,
i) understanding the extent to which IP and TT activities are essential to bring new cell-based therapies to patients with chronic wounds that do not heal.
(ii) define the best practices to be followed in the pathway from preclinical to clinical application of cell-based therapy and compare these pathways in Italy and Austria and
(iii) import the missing best practices in either country, with the involvement of stakeholders (professionals working with and/or at the relevant regulatory authorities in Italy and Austria).
Report 1 – Map of pre-clinical and clinical expertise on adipose tissue cell therapy for wound healing in Austria and Italy.
Report 2 – Guidelines on wound assessment modalities and cell characterization.
Report 3 – Report on procedures to prepare an Investigational Medicinal Product Dossier – IMPD for cell therapy in Italy and Austria and network of researchers, clinicians and regulators interested in cell therapy in the program area.
Policy Paper on best practices to be imported to facilitate the adoption of cell therapy in the clinic (coming soon).