A new strategic model for a sustainable development and maintenance of advanced therapies on the market (FISA 2022 – SustainableATMP)

PROJECT DESCRIPTION

The FISA project, titled SustainableATMP, aims to implement a strategic and economic model that enables the sustainable development and long-term viability of Advanced Therapy Medicinal Products (ATMPs). The project leverages prior expertise in regulatory validation of ATMPs and proposes an innovative two-stage model for the development of a 3D bioengineered human cornea.

Two key outcomes:

• Product 1: A GLP-compliant 3D human cornea organoid used for pharmacological and toxicological in vitro testing, serving cosmetic, pharmaceutical, and biomedical sectors.
• Product 2: A GMP-compliant full-thickness corneal substitute (an ATMP) for clinical applications in corneal diseases and injuries.

This two-product development strategy introduces an economic innovation: a self-sustaining research path wherein early revenue from Product 1 can support the development of Product 2.

PROJECT INFORMATION

Grant Agreement ID: FISA 2022

CUP: E53C24004200001

Start date: April 2025 – End date: March 2030

Total Cost: € 3.500.000,00

COORDINATOR:

UNIVERSITA’ DEGLI STUDI DI MODENA E REGGIO EMILIA (Italy) – PI Coordinator: Graziella Pellegrini

SCIENTIFIC AND ECONOMIC ADVISOR:

Stefano Cosma

INDUSTRIAL PARTNERS:

parnerships ongoing of definition