In recent years, research experienced a major transformation, thanks to the introduction of in silico medicine (or computational medicine). This approach, based on virtual simulations and studies, exploits the potential of artificial intelligence and machine learning, allowing the creation of particularly accurate computational models which are also more representative of the complexity of the human body.
Therapeutic Areas
IBSA & in silico medicine: four projects in development
IN SILICO MEDICINE: WHY USE IT?
Thanks to access to a vast and diversified pool of biological, genetic and clinical data, in silico medicine – in combination with traditional in vitro and in vivo experiments – can make an important contribution in complex clinical situations, such as identifying the optimal dose of a drug or calculating the risk of drug-drug interactions.
In other words, in silico medicine exploits the “digital twins”: virtual patients that allow to simulate complex biological processes and predict the effects of drugs and treatments on the digital model instead of the human body. The objective of in silico medicine is to use this large amount of data to improve the accuracy of research, reduce risks for patients and extrapolate information on specific segments of the population, such as children, elderly and pregnant women.
Despite being in an exploratory phase, where researchers are still discovering its potential and limitations, this new frontier of science already promises great benefits for pharmaceutical research and, more generally, for the health of all humanity.
FROM SIMULATION TO REALITY: WHAT ARE THE BENEFITS OF IN SILICO MEDICINE?
Precision: digital simulations take into account variables such as age, sex, health conditions and even individual genetic heritage. Such accuracy also improves the ability to personalise treatments, thus increasing therapeutic efficacy and reducing side effects.
Risk reduction: in silico medicine helps limit patients’ exposure to experimental drugs that may have unexpected side effects. In this way, drug development processes are accelerated and patients’ protection is increased, leading to safer and more effective treatments right from the early testing phases.
Integration of historical clinical data: the in silico approach allows to recover and use previously collected clinical data, thus widening the pool of studies and research that are to be finalised.
Reduction in trial times and costs: thanks to the use of computational models, it is possible to carry out simulations in a much shorter time than with traditional methods (in vivo and in vitro studies), thus accelerating the R&D phase.
IN SILICO TRIALS “MADE IN IBSA”
IBSA is actively exploring the potential of in silico medicine through four projects, all conducted in the United States, which exploit the digital twins technology to simulate human physiology, predict drug efficacy and safety, and overcome the ethical and logistical limitations of enrolling real patients.
Study on paediatric pain
The first project concerns an investigation into pain in paediatric patients. The goal is to compare treatment effectiveness between real and synthetic patients using the digital twins to expand the study sample and reduce the number of children subjected to clinical examinations. The study, recently concluded, was submitted to the FDA (Food and Drug Administration, the US federal agency that deals with the regulation of food and pharmaceutical products) and is awaiting green light.
Non-inferiority studies in osteoarthritis (OA)
Two non-inferiority studies are underway to compare an IBSA product with the current market leader in the field of osteoarthritis. Using in silico data, IBSA aims to demonstrate the equal effectiveness of its drug and the reference one.
Extension of therapeutic indications for OA
Another project in the field of osteoarthritis concerns the use of in silico medicine to extend the therapeutic indications of an already existing product. Using both historical and current data, IBSA aims to obtain a new indication without having to enrol new patients.
Bioequivalence study
Finally, IBSA is conducting a bioequivalence study between one of its own drugs and a medicine that was market leader but is no longer on the market. Thanks to in silico medicine, it is possible to recover the clinical data of a treatment no longer on the market and verify its bioequivalence, i.e. that there are no significant differences regarding the speed and quantity of bioavailable active ingredient compared to the reference drug.
THE NEXT CHALLENGES FOR IBSA
Despite its great potential, in silico medicine also presents complexities. One of them is the interpretation of the results, which requires deep technical knowledge and the integration of different disciplines, such as computational engineering and statistics.
To ensure that models are accurate and data are interpreted correctly, IBSA is investing in dedicated teams and is working closely with Regulatory Authorities (the Food and Drug Administration in the United States and the European Medicines Agency in Europe) to align itself with international guidelines and ensure that its studies meet the required quality standards.
