What we doWe de-risk research & development decisions by predicting the clinical benefits of new drugs before human trials
#insilicomedicine #predictiveanalytics #biomodeling #computersciences
Clinical insights & strategy
Optimize trial design and capture best responders
NOVA’s in silico clinical trial technology operates as a digital sandbox in which multiple assumptions can be tested ahead of in vitro and in vivo assays cheaper and faster with the ultimate objective to de-risk clinical development decisions.
At each step of the development process, we help our clients focus time and resources on the best scenarios:
- Right drug regimen
- Right patient & biomarker
- Right trial design
Use case in lung graft rejection
With 50% of deaths after 5 years, lung transplantation has the worst outcome of all solid organ transplants. Chronic Lung Allograft Dysfunction (CLAD) affect many lung transplant recipients but the late identification of patients at risk and the inefficacy of existing drugs have prevented substantial improvements in care.
The formal representation of the mechanistic cascade of events that characterizes the natural history of CLAD, with 2 interconnected systems (the immune system and lung fibrosis), led to the implementation of an in silico trial to test everolimus, an mTOR pathway inhibitor.
According to simulation outputs, the trial size could be reduced from 2,929 patients using the conventional sizing approach to 566 using our Effect Model methodology, translating into €70.8 million of potential savings. This also illustrates the ethical impact of in silico trials: by profiling the right responders, we mitigate the risk of enrolling uninformative patients in in vivo trials.
A series of corresponding novel biomarkers were also identified in silico (pollution intensity, ischemia reperfusion intensity, CMV infection duration, myeloid differentiation…).
What we do
It is now important for the European Medicines Agency to recognize and integrate into its regulatory processes these new methods of in silico simulation and prediction.
François-Henri BOISSEL introducing NOVA at Labiotech Refresh 2017, Berlin.
Specify the optimal duration which helps to obtain the target effect, the dose that has to be used to maximize this effect. In other words, it’s to help us do the operations that are done today by a rather theoretical approach.
With the help of in silico models we can integrate the right patients in clinical trials and reduce the size of these trials.