BiomimX is an R&D-performing SME specialized in the development of Beating Organ-on-Chip (OoC) platforms, a new generation of in vitro preclinical tools, built upon BiomimX proprietary cutting-edge technology, which enables to generate in vitro replica of human tissue with an unprecedented level of maturation. This technological platform allows for reliable, faster and more affordable screening of drug and medical devices.
Also thanks to the contribution of Women TechEU programme, BiomimX aims at demonstrating the unprecedented potential of its disruptive innovation in reshaping the market of drug development, by i) boosting technological aspects and ii) proving the versatility of its innovation and its capacity to adapt to a manifold of indications and market spaces. The success of BiomimX ambitious plan will be guaranteed by a solid IPR, a strong internal know- how, and already identified partnerships with EU leaders in industrialization, regulations for preclinical drug safety screening and clinical partners.
The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. The cost to develop a new single drug is today estimated around 2.8B$ and the average time to market is 12.5 years, with both trends continuously growing1. Less than 1/10’000 of the initially investigated candidate drugs reach the market, while the others fail along the way2. The further in the drug discovery pipeline (DDP) the failure occurs, the higher is the waste of investment, in terms of money, time and human safety. Notably, only less than 12% of new candidate drugs make the transition from pre-clinical to clinical development1. Nonetheless, despite this great waste, the risk to introduce in clinical trial ineffective or even toxic molecules is still high, due to the poor predictability of the currently exploited preclinical test models. Such negative trends are mostly related to the accepted reality that current preclinical tests are only an imperfect representation of the human system, thus providing unreliable data often insufficient to guide preclinical-to-clinical transition, where solid and clinically relevant outcomes would instead facilitate safer and more reliable go/not-go decisions. Currently available preclinical tools for testing drug safety/benefit indeed rely either on i) bi-dimensional (2D) cell culture methods poorly resembling native tissues complexity and thus failing in capturing human responses, or ii) animal models, that often lack in predicting human responses due to inter-species differences. Moreover, 3R principles are forcing Pharma to reduce the use of animals (Directive 2010/63/EU): EU Parliament (EP) recently voted yes to a to a future without animal experiments and “It is now in the hands of the European Commission to establish this EU- wide Action Plan, and we expect the EC will make this a high-level”, said Jytte Guteland (EP member) 3.
BiomimX is at the frontline to speed up this resolution, contributing to a key EU priority, by offering its in vitro human advanced models as visionary tools for reducing (and eventually replacing) animal testing in preclinical DDP.
