InSilicoTrials has teamed up with IBSA to increase the use of models in clinical trials citing FDAMA 2.0 as a driver.
The partnership – financial terms of which were not provided – will use in silico techniques – such as computer simulations and mathematical models - to make predictions about toxicity, efficacy, optimal dosing strategies in trials.
In-silico techniques will also be used to guide other stages of the drug development process from discovery through the nonclinical and clinical phases, registration as well as to leverage post-market real-world data.
The firms cite regulatory calls for greater use of predictive techniques – notably the US Food and Drug Administration (FDA) Modernization Act’s (FDAMA- 2.0) flexibility around the use of alternatives methods to animal testing, such in silico testing, before or during the clinical trial phase.
According to InSilicoTrials and IBSA the underlying aims of the collaboration are “reducing working times, lowering research costs, and implementing effective therapeutic solutions in less time, positively impacting healthcare expenditures.”
This was echoed by IBSA, which set out the benefits of in-silico modelling in clinical development in a statement on its website.
“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.”
“Suffice it to say that the US FDA itself 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).
IBSA added that “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.”
The agreement with IBSA is one of a number of deals InSilicoTrials has signed this year, the most recent of which was its collaboration with Italian healthcare consulting organization CD Pharma.
InSilicoTrials also teamed-up with Achilles Vaccines in a partnership focused on product development.
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