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Exploiting the promise of in silico trials

December 05 2016

An excellent example of in silico tools to support computer-based clinical trials is the Belgian Virtual Physiological Human, but there is still a lot to do before it aligns with the human physiology sufficiently. 

Although there are several barriers to overcome, the time in which in silico trials can truly provide individualized simulations for the development or regulatory evaluation of a medical intervention or device may be dawning. But why should we allocate budget to develop new in silico simulation technologies? Is there a true need for radical innovation in the way we develop and assess biomedical products?

Exploiting the promise of in silico trials: an infographic

We take it at face-value that the sluggish behemoths, that are phase three clinical trials, are necessary and required for product development in the biomedical- and pharma industries. Rightly so, because safety and efficacy can only be known after actually showing it. Yet, these behemoths leave many casualties in their wake; patients see the promise of a cure getting pushed onward in time, promising therapies fail, and the financial devastation they leave behind is considerable. These beasts need to be tamed or they threaten to ruin us.

in silico trials

An in silico clinical trial is an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. ‘Virtual’ patients would be given an in silico drug or treatment, enabling observation through a computer simulation to assess performance and effectivity without inducing adverse effects.

In sum, by making use of sophisticated modeling approaches, in silico trials can provide the explanatory power that a statistical model cannot provide. The EMA and the FDA advocated the use of such systems as an additional innovative research tool, which are increasingly being accepted as supporting evidence for approvals.

The promise of in silico trials

Some believe that in silico can completely replace clinical trials, while others support the notion that in silico simulations can strongly support in vivo trials. However, there appears to be a consensus that in silico trials can increase the performance in all three major bottlenecks of in vivo trials. Extensive use of in silico technologies could allegedly reduce the overall cost of drug development by as much as 50%.

In addition, they can reduce the size and the duration of clinical trials by identifying characteristics to determine which patients might be at greater risk of complications or providing earlier confirmation that the product is working as expected.

The binning of products that were deemed unsafe or ineffective will also reduce, because in silico analysis can provide information that could be used to improve the product to overcome the reason for abandonment.

Towards implementation of in silico trials

A data-acquisition and model integration tour-de-force – but also smart new ways to collect, process, utilize information – are required to launch stand-alone in silico trials. Funding bodies have recognized the barriers to functional usability of in silico trials and have supported initiatives that build the foundation for innovation. Currently they have funding opportunities to support the development of tools to support product development:

Horizon 2020 – Societal challenge 1 health, demographic change, and wellbeing (€658M)

A research and technological roadmap on in-silico trials that are the use of individualised computer simulations in testing is currently available showing both strong interest and potential benefit of expanding the computer-modelling in drugs and other biomedical products research.

The purpose of this call is to support studies developing and researching in-silico clinical trials (ISCT) to reduce animal and human testing

Deadline: 14-03-2017 / total budget 19M / project budget 4-6M / multidisciplinary consortium of at least 3 legal entities of 3 different EU member states

More, innovative methods are needed for better understanding the influence of biological (including microbiome), social, environmental, lifestyle, occupational, economic etc. factors on human physiology and thereby on well-being and health.

The purpose of this call is to support the development of new integrative simulation systems with application in well-being, health and disease.

Deadline: 14-03-2017 / total budget 19M / project budget 4-6M / multidisciplinary consortium of at least 3 legal entities of 3 different EU member states

ttopstart can support you 

At ttopstart we are specialized in the support of competitive grant applications in the area of life sciences and we have the expertise to position your in silico innovations for maximal impact. If you are developing solutions and are seeking support for your project, feel free to contact ttopstart

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Contact

Boaz van Driel, PhD
+31 614 842 950