18 January 2019
Organ-on-Chip in Development (ORCHID) is a European Horizon 2020 project that aims to capitalise on the innovative technology that is organ-on-chip, or OoC. The ORCHID consortium is made up of seven partners from six European countries and was launched in 2017 with the overall aim of building a network of OoC stakeholders, including academic, research, industrial and regulatory institutions, in order to move OoCs from laboratories to a more global awareness and utility.
We are in the midst of a ‘drugs drought‘, which means there could be no more new, approved compounds by around 2070 unless we radically alter the current drug discovery paradigm. Using animals as models of human disease for predicting safety and efficacy of novel drugs has proven to be time consuming, costly and about as effective as tossing a coin—with failure rates running as high as 99.6 % for some conditions. While the reasons underpinning the failure of new chemical entities to reach the clinic, and successfully remain there, are complex and multi-factorial, there is no doubt that one of the greatest limitations for identifying new therapeutics for human diseases is the deficiencies in the animals employed/manipulated as models of the human condition.
OoC offer an ethical, human testing platform which is a vast improvement on both conventional animal and most other in vitro assay systems, and could provide a route through the currently stagnant waters of drug development. OoC technology brings together tissue engineering, semiconductor and polymer microfabrication and human cell culture (including primary cells, tissue explants or induced pluripotent stem cells) in order to create organ systems with equivalent dynamics, functionality, physiological and pathophysiological responses to those in vivo. Rapid advances in these technologies are permitting the creation of multi-organ chip (MOC) systems which are quickly moving towards the creation of the Human-on-Chip and the much sought-after Patient-on -Chip.
The ORCHID roadmap steers the way through the urgent need to reinvigorate the drug development pipeline with the temptation to offer OoC as the answer to everything. This report combines expert input with bibliometric analysis of the field and a market report to provide a realistic snapshot of the state-of-the-art for OoC. It admits that there are hurdles to overcome before this new technology is able to address the overall aim of EU Directive 2010/63 – replacing animals in science – and provides global citizens with much-needed treatments, but it puts forward recommendations to further progress towards these goals. The ultimate key recommendations pair up the unmet needs and existing challenges that will need to be dealt with in order to create the global regulatory acceptance that is needed to enable wider use of OoC and to allow the regulatory acceptance of data generated from OoC that will see them replace animals.
The clarity of suggestions described in the roadmap, the relative linearity of the route proposed and the speed at which this field is developing offers great hope for overcoming the challenges and unmet needs outlined. Already, we have seen increased public and private funding for OoC, reports of mature heart models, real-time monitoring of muscle contraction and MOC used for ADME in toxicity testing. So, as much as we try not to proffer OoC as the answer to all our prayers for developing new, safe and effective drugs that can reduce the animal body count to the ultimate goal of zero, we cannot fail to be excited to see how, and when, these promising little devices will achieve this.