Therapeutic Areas

In silico medicine, Modelling and Simulation (M&S): the last frontier of clinical trials

In recent years, a new model of clinical trials has been gaining ground, supporting – or sometimes replacing – traditional in vivo or in vitro studies. We are talking about in silico studies, a branch of medicine that uses algorithms to create computer models and provide clinical data without resorting to trials on living beings or in test tubes.


The use of in silico testing plays an increasingly important role in the development and evaluation of new pharmaceutical products. The in silico approach involves the use of several computational tools, such as computer simulations and mathematical models, to study biological systems – from the molecular to the cellular, up to the organism level. In silico techniques can provide predictions of toxicity, efficacy, optimal dosing strategies, and study design. The in silico trials are currently employed to guide the different phases of the drug or medical device development process, through both the non-clinical and clinical phases and the drug registration process, also exploiting real-world e post-market data.


In addition to having obvious ethical advantages, since drugs or medical devices can be tested on virtual individuals, in silico simulation also allows for the reduction of testing times and costs. It’s a very “hot” and current topic. Suffice it to say that the US FDA itself (the Food and Drug Administration, i.e. the American drug agency) has set up an ad hoc working group made up of over 200 scientists dedicated to the analysis of the possible fields of application of Modelling and Simulation (M&S). Furthermore, the bill Modernization Act – FDAMA – 2.0, issued in September 2022 by President Biden, allows for the use of alternative methods to animal testing, such as in silico testing, and aims to simplify drug regulation and bring safe medical products to the market faster.


IBSA, which has made innovation one of its pillars, is carrying out a series of studies with this new methodology, with the support of a partner specialised in in silico medicine: InSilicoTrials. Being able to reduce working times undoubtedly also leads to a positive reduction in research costs. In turn, this has a beneficial effect on the ability to implement effective therapeutic solutions in less time, so as to have a positive impact also on the healthcare expenditure of the various countries. IBSA is evaluating the application of the in silico medicine in some specific therapeutic areas, such as pain and inflammation, osteoarticular and reproductive medicine.