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
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.