Patients all over the world should benefit from the achievements of predictive medicine and the introduction of in silico clinical trials (ISCTs), which promise the accelerated and safe introduction of new products such as medical devices or pharmaceuticals to the market place. These concepts cannot be developed by academics or in industry alone, and ultimately they need to be accepted by regulatory agencies around the world. When regulators accept simulation augmented submissions, and agree upon a common model credibility assessment philosophy will patients benefit from the utilization of in silico medicine.
The objective of the Avicenna Alliance International Working Group is the promotion of the benefits of predictive medicine and ISCTs through the global connections of experts from academia, industry, and regulatory agencies. Together we will work on developing objective standards, increasing confidence in in silico methods and their acceptance in support of regulatory approval process.