In an earlier NAT SIG article, the conclusions of a 2-year European Commission funded project entitled “In silico clinical trials: how computer modelling and simulation will transform the biomedical industry” were discussed. Built into the project requirements by the European Commission was the need to develop a pre-market alliance of industries and researchers engaged with in silico medicine that would represent this sector and aim at promoting in silico medicine in policy and research.
This group entitled “the Avicenna Alliance” has now been launched and the partnership between healthcare & software industries together with academic researchers in the Virtual Physiological Human (VPH) Institute is up and running, with an ambitious programme for its first year in 2016. Here, James Kennedy, EU Policy Consultant at the Alliance describes the aims and the ambitions of the group.
The group’s overarching goal is to create a policy and research framework that enables the in silico market, allowing greater uptake of in silico solutions in the pharma and Medtech fields. For the Alliance’s Secretary General Adriano Henney, such a policy framework is vital to addressing major inefficiencies and research costs within the healthcare industry.
“In silico medicine has so much to offer healthcare industries by improving efficacy, drastically reducing research costs and, crucially, allowing them to demonstrate the value of their products, through an improved understanding of how complex physiological systems respond to therapies, often in early development” says Henney. “Right now a policy framework for the acceptance of in silico data simply does not exist and this needs to change if we are to realise this potential fully. Even the most predictive model is of little use to industry if the data cannot be submitted as part of a marketing authorisation or proof of product value. We intend to work with our Members to create a policy framework that allows them to submit this data and ensure the value of their products is seen.”
The Alliance in 2016 will be engaging with the Commission and FDA to look towards common policies on in silico with the aim of ensuring that policies are harmonized from the very beginning. It will also be looking towards creating training schemes between its industry and VPH members providing a chance for students to gain experience in industry and for industries to assess new talent.
Dr. Henney feels that there is strong appetite in Brussels for policy along the lines of what the Alliance is seeking to create, much of which has developed as a result of the considerable focus on personalized medicine and big data.
“There is a great deal of talk about both the potential of big data and the promise of personalized medicine. The question now is how do we get from one to the other? For Avicenna Alliance members the bridge between the two is modelling and simulation; it’s in silico medicine.”
More information about the Avicenna Alliance and their activities can be found at Avicenna-alliance.com