SustainableATMP - A new strategic model for a sustainable development and maintenance of advanced therapies on the market

The project proposal foresees the implementation of a strategic and economic model for the sustainable development and maintenance of advanced therapy products (ATMP) on the market. The presenting working group will take advantage of the expertise gained in the latest years on the validation process required by the regulatory authorities to commercialize ATMPs or related products. Funding ATMPs means addressing a plurality of high specific, regulatory and ethical risks. The long timescale of clinical research, the high and increasing realization costs, the difficulties in assessing the probability of success, the regulatory uncertainty of pricing and the risk of reimbursement make the traditional criteria for financial decision-making and allocating financial resources ineffectively. The market failure and the consequent rationing of medical research generate both allocative inefficiencies, inequities, and social costs. The ATMP and the economic models tested in the project consists of developing a threedimensional (3D) organoid prototype of the whole human corneal tissue, functionalized with autologous primary cultures of the two epithelial layers: epithelium and endothelium. The organoid of the human cornea obtained within the project will be used to develop two subsequent products for different applications and two economic models. The 3D bioengineered transparent corneal substitute with a physiologically regulated cellular microenvironment would be used for assessing drugs' pharmacological and toxicological service (PRODUCT 1), producing profit to support the later development of the ATMP substitute of corneal tissues for clinical applications in irreversible damages of different corneal districts (PRODUCT 2). The creation of a two-stage development path, which tends to coincide with the bio-clinical needs of development and experimentation, activates a new element of economic-financial reflection: the self-financing capacity of the same research in ATMPs.