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Will in silico clinical trials revolutionize drug development?

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by Dr. Bertalan Meskó, The Medical Futurist

Clinical trials today are long and expensive. Pharma companies spend billions of dollars and still, at the end of the day a drug might not become approved. On the one hand, this creates a huge risk for them to invest into innovation, on the other hand patients sometimes have to wait for unnecessarily long until a new drug reaches the market.

What if it is time to use disruptive innovations to change how clinical trials are performed? Imagine the following: neither animals, nor humans are the subject of the lengthy and costly drug creation process, but their characteristics are so perfectly simulated that the clinical trial can be carried out in less time, with less money and still amazing results. This method is called an in silico trial.

An in silico clinical trial is an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. While completely simulated clinical trials are not feasible with current technology and understanding of biology, its development would be expected to have major benefits over current in vivo clinical trials, and research on it is being pursued.

Imagine if we could test thousands of new potential drugs on billions of virtual patient models in minutes? What would it take to achieve such a capability? At the very least, the virtual patients must almost perfectly mimic the physiology of the target patients, with all of the variation that actual patients show. The model should encompass circulatory, neural, endocrine, and metabolic systems, and each of these must demonstrate valid mechanism–based responses to physiological and pharmacological stimuli. Probably cognitive computers would be needed to deal with the gargantuan amount of resulting data.

HumMod is one of the most advanced simulations in this respect. It provides a top–down model of human physiology from whole organs to individual molecules. It features more than 1,500 equations and 6,500 variables such as body fluids, circulation, electrolytes, hormones, metabolism, and skin temperature. HumMod aims to simulate how human physiology works, and claims to be the most sophisticated mathematical model of human physiology ever created. HumMod has been in development for decades and it is still far from completion. It may take decades to get there.

Maybe supplementary technologies are needed. The Organs-on-Chips technology is able to use stem cells to mimic organs of the body with a series of devices. Many experts believe that this technology could revolutionize clinical trials and replace animal testing completely. Organs-on-Chips are engineered to mimic how the lung or the heart works at the cellular level. They are translucent, and so can provide a window into the inner workings of a particular organ. The Wyss Institute plans to build ten different organs–on–chips and connect them together. Doing this may mimic whole–body physiology better, and thus better assess responses to new drug candidates.

However, we should note that although the experiments are promising, these are still far from a real and total-body simulation of human physiology. Even if organs could be mimicked, connecting the models to each other is more complicated than we would think.

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