One of In Silico World’s goals is to allow the medical industry to get involved in a fast-growing sector by shortening the time-to-market, reducing loss revenues and preserving the levels of reliability of traditional methods.

The industry

Industries working in the health sector know very well that every new product (drug, medical device, etc.) must undergo an extensive risk assessment, which in most countries and for most class of hazardous products is regulated by law.  

Until 2016, neither the USA Food and Drugs Administration (FDA) nor the European Medicine Agency (EMA) allowed to produce any primary evidence in the regulatory process that was obtained through computer simulation, making sure that lack of acceptance from the regulatory agencies would be recognized as the main perceived barrier to adoption of In Silico Trials.  

This led to the paradoxical situation where the global simulation software market was valued at $5 billion in 2017 and is projected to reach $10 billion by 2025, with a compound annual growth rate of 8.9% (Allied Market Research1), while the fraction of this market targeting In Silico Trials products is still negligible.

The In Silico World consortium had identified seven barriers that are slowing down the wider adoption of In Silico Trials: 

1. Lack of advanced models

2. Lack of independent validation collections

3. No clear regulatory pathways

4. Poorly informed stakeholders

5. Poor scalability and efficiency

6. Lack of trained workforce

7. Lack of business models


> Check out the detailed Barriers


It is important to overcome such barriers, since the adoption of In Silico Trials could drastically reduce animal and human testing, could significantly lower the development costs of medical products and shorten their time-to-market, while preserving the same levels of reliability of the traditional pathways 

Our approach includes the involvement of the medical industry (individuals or whole companies active in the healthcare industry, directly or through their trade organisations), software companies and small and medium enterprises developing and selling In Silico Trials services, and Contract Research Organisations, in the process of developing consensus around the so-called Good Simulation Practices.


> Check out the GSP

Resources for industry

The consortium expects the results of the project to accelerate the adoption of In Silico Trials, by lowering the even barriers listed above. This will increase the trust in these innovative technologies by regulatory agencies, clinicians and patients, and ultimately change the design of regulatory trials to include in silico technologies. 

Once per year our partners hold an International School on In Silico Trials where industry decision-makers without a specific technical background are trained by an international faculty to conduct a Strengths-Weaknesses-Opportunities-Threats (SWOT) on the adoption of In Silico Trials technologies in their company.


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