Organ-on-a-chip a New Paradigm in Drug Discovery and Development Process

Drug discovery and development process involve steps such as identification and validation of drug targets, understanding pharmacokinetics, drug toxicity and efficacy studies, drug safety screening and clinical studies of the final drug product. The estimated total monetary investment required for discovering and developing new drugs averages > $2 billion and further process of taking a synthesized compound to the market as a drug is time-consuming 12-15 years.

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA, 2018), only one or two of every 10,000 laboratories synthesized drugs pass through all the stages and reached the market. For instance, only 59% of the drugs are entering into Phase II and of it, only 21% are reaching the next phase i.e., drugs entering clinical development are less than 12%. Most of the drugs fail in clinical trials due to a lack of efficacy (43%), due to toxicity issues (33%). This shows that the basic research and preclinical development phases based on animal models and in – vitro testing (cell culture) are not often predictive enough to assess the efficacy and toxicity in clinical trials. Organs in the body are of a 3D nature that complex behavior of cells cannot be adequately modeled in 2D cultures such as 96-well plates. Also, the response of the animal models to the new compound does not necessarily give a similar result in humans due to their physiological difference. So there is a need for a better predictive model which could be filled in by Organ-on-a-chip.

Organ-on-a-chips (OOCs) are biomimetic microsystems developed by the convergence of microfabrication and tissue engineering, which are composed of a clear flexible polymer of the size of a computer memory stick containing hollow microfluidic channels lined by living human cells interfaced with a human endothelial cell-lined artificial vasculature. Incorporating the vasculature into organs-on-chips mimic the physiologically appropriate responses. Organ-on-a-chip is considered to be a game-changing technology bridges the gap between preclinical testing and human trials through better predictive models, significantly impacting R&D costs. There is an expectation to solve the persisting problems in drug discovery and personalized treatment method development. For instance, the use of OOC in in-vivo testing experiments is expected to reduce drug development costs atleast by 7.5-10%.

Organs-on-chip serves as a new enabling platform to increase accurate validation of organ-specific and effective therapeutic targets by understanding the pathogenesis of human diseases, which in turn increases the likelihood of success in clinical trials by employing efficient single organs, multi-organ and disease model-on-a-chip. Vascularizied tumor model helps to study cancer metastasis and angiogenesis. The emerging tumor-on-chip devices are applied in many areas of cancer research to study the physiology of solid tumors helps the screening of novel anticancer pharmaceutical compounds. Advanced stem cell culture (induces pluripotent stem cells) helps to develop well-characterized diseases models ((NASH, Asthama, COPD, etc.) enabling the possibility of capturing the genetics behind the disease in an organ-on-a-chip. Toxicity of the newly developed drug is tested on a single organ on-chip model (For example liver-on-a-chip, lung-on-a-chip, Heart-on-a-chip, Nerve-on-a-chip etc.,) in order to assess toxicity effects on a particular organ, where multi-organ-on-a-chip facilitate the observation of the compound’s effect on the target organ and others. For instance, networking of liver-on-a-chip along with gut and kidney would help in exploring the drug absorption, and disposition post-liver metabolism. Further, body-on-a-chip or human-on-a-chip aims to even eliminate or reduce the need for humans in Phase I and Phase II, directly entering Phase III clinical trials.

Most of the pharma companies are focusing on organ-on-a-chip technology, to use as alternative to animal models in drug development. Although the technology is relatively new, it is expected to move into mainstream drug development with advancements taking place in the field of single organ-on-a-chip, multiple-organ-on-a-chip, and patient-specific human disease models which tend to increases the collaboration activities taking place between organ-on-a-chip companies and pharma companies (AstraZeneca, Roche, Takeda Pharmaceutical and Bayer AG, GlaxoSmithKline, Merck, Novartis, Pfizer) brings a fundamental change in the drug development process. For instance, Emulate, Inc. collaborated with Takeda Pharmaceutical Company Limited, where Takeda uses Emulate’s Intestine-Chip for range of R&D activities — from discovery, to drug evaluation, to biomarkers to expand innovation in the drug discovery process for gastrointestinal (GI) diseases.

The key players in Organ-On-A-Chip Global Market include Mimetas BV (The Netherlands), Emulate, Inc. (U.S), TissUse GmbH (Germany), Hesperos, Inc. (U.S.), Insphero AG. (Switzerland), CN Bio Innovations Ltd (U.K.), Nortis, Inc. ( U.S.), AlveoliX AG (Switzerland), Organovo Holdings, Inc.(U.S.) and others.

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