The problem that we address is that the pharmaceutical companies do not develop radically new drugs anymore, because the development process lasts ten years and costs around one billion euro. Development of a new drug is subjected to regulatory approvals following three demonstrations: lab discovery in vitro, animal testing in vivo and clinical trial on patients. This process has 99.9% overall failure, of which 96.4% because the drug efficacy measured in vitro is not confirmed in animals. In fact, the most widespread technology used to test therapeutic agents in vitro, a flat culture dish in which single cell populations are cultured and the drug to be tested is added to the culture, is obsolete. In many pathologies such as cancer and neurodegeneration, in vivo response to drugs is based on complex interactions, occurring in three-dimensions (3D) between several cell populations. To solve this problem, in the context of an ERC consolidator grant (CoG) that I currently lead, I integrated a novel nano-patterned 3D substrate for stem cell culture, called the “nichoid”, into an existing miniaturised optically accessible bioreactor (MOAB). The MOAB allows to culture 3D organoids of few millimetres in size, under continuous perfusion of the culture medium, infusion of the drug to be tested and diagnostics of cell response both in real time and also post-cultivation. Both the original inventions (the nichoid and the MOAB) are covered by Italian patents originated in the frame of the CoG project and already extended as PCT. The goal of this PoC proposal is to perform a technical and commercial feasibility to move to the market the MOAB device integrating the nichoid-patterned substrate. I will characterize the fluid-dynamics of the bioreactor chamber that has been modified to accommodate the nichoid substrate. Also, I will set a market assessment and an actionable IPR strategy with identification of a suitable exploitation strategy for valorising the patent/know how.
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