In the last two years, pharmaceutical companies have become increasingly interested in the possibilities in silico technologies bring to the world’s multi-billion-dollar drug development market. Among the factors that have been reported as drivers of recent interest in what is also known as virtual clinical trials are the COVID-19-related restrictions that began impacting traditional human-based clinical trials in 2020.
In silico drug development utilizes real-world data (RWD), artificial intelligence (AI), computational biology, and mechanistic modeling to predict the efficacy and safety of drug treatments or to simulate control arms in clinical trials. By reducing the risk of failure or the size of control arms, in silico drug development is cost-effective and promises to create safer, more efficient drug development, reducing the time it takes to bring a drug to market. Although it represents only a small fraction of the annual global spend on drug development, the value of the in silico drug development market is expected to reach nearly $3 billion by the end of 2022.
Also, most importantly, by accelerating research and development (R&D) timelines, in silico drug development has the potential to bring better outcomes to patients faster.
With the goal of reducing R&D costs and time-to-market of novel therapies, some companies perform in silico simulation in different stages of drug development for pharma and biotech companies throughout the world. In silico simulation reduces R&D decision-related risks by predicting the clinical benefits of new drugs before a human trial is conducted and helps identify ineffective therapies at an early stage, or partly replaces and complements costly clinical study control arms, saving drug developers time and money.
U.S. regulators weigh in on reduced animal testing
Regulatory agencies also recognize the value of the virtual clinical trial model and regulators are expected to endorse an increasing range of therapies that begin their development journey in an in silico trial. In its report entitled 2021 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science, the U.S. Food and Drug Administration stated that the emergence of in silico trials has the potential to “replace, reduce, and refine reliance on animal testing.”
According to the report, “In some cases, in silico modelings such as using available information in computational science approaches to predict safety issues, can be used to supplement and may potentially replace risk analyses that are currently based on animal data.” By relying less on animal testing, pharma and biotech companies will have the advantage of utilizing more human-based data in the development of novel therapies.
Giving patients access to personalized medicine
In silico technologies also enable drug developers to perform, in theory, an unlimited number of tests using a wide range of variables that include age, sex, and the health status of each member of the virtual patient pool, compared to the more restrictive parameters of a traditional trial. By reducing the amount of trial and error involved in collecting data, drug developers can focus on therapies that prove to be more effective in treating a specific group of patients.
This increase of data related to the way a drug impacts specific patient populations will also help drive the development of personalized medicine. By performing in silico studies, drug makers will have the opportunity to develop better-targeted therapies for patients with critical diseases such as cancer, through the benefit of data that provides a deeper look at how each patient reacts to a treatment.
As the prevalence of in silico drug development increases in the years ahead, the pharmaceutical and biotech community is optimistic that more effective and affordable treatments will become available to the people who need them, and positive patient outcomes will rise dramatically.
Tanja Dowe is a health care executive.
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