Avicenna Alliance – Review 2016

Early 2016, the first success was scored by amending the EMA Regulation in a way that it now includes a reference to the need to consider in silico models, alongside others, in the evaluation of novel medicines. A similar success was achieved with the inclusion of a reference to in silico approaches in the revised Medical Devices Regulation. These two significant achievements are early indicators of the ability of the Avicenna Alliance to exert influence on policy through the advocacy channels it has established, boding well for the future.

Throughout the year, the Alliance continued its outreach to regulators, stakeholder groups and potential new members. Strong connections were established with the Food and Drug Administration (FDA) who are working on their own internal strategy for modelling and simulation and who are keen to work with the Avicenna Alliance to harmonise approaches to policy development for in silico medicine.

In parallel to that, the Avicenna Alliance has also established concrete discussions with the European Medicines Agency (EMA), through their Modelling and Simulation Working Group, the Norwegian Regulatory Agency, and the Danish Regulators, exploring the potential with the latter for the Avicenna Alliance to contribute to the Heads of Medicine Agencies task force on Big Data.

The VPHi was appointed to the European Commission’s eHealth Stakeholder Group. With VPHi representing 50% of the membership of Avicenna, this provides the Avicenna Alliance access to a key influential group through which the Alliance has a route to present its views in discussions relating to all matters of eHealth, mHealth and the part those have in the Digital Single Market.

The Alliance has also been invited to participate in discussions on in silico contributions to toxicology at the EU Reference Laboratory at the EC Joint Research Centre in Ispria, Italy, with a view to exploring potential partnerships and collaborations.

In October 2016, the first event of the Avicenna Alliance took place in the European Parliament, hosted by MEPs Nicola Caputo (S&D, Italy) and Sean Kelly (EPP, Ireland). With not a single seat free and standing room only for a number of attendees, the event showed that huge interest exists in what might have been considered a niche topic.

In terms of publications and press releases, for a new organisation the Avicenna Alliance has had some significant wins, not least with publications in French medical news outlets and, in December, an article in the institute of Mechanical Engineering journal “Professional Engineer”.

Avicenna Alliance is very pleased to have been joined by Edwards Life Sciences and, more recently Johnson & Johnson and the Avicenna Alliance is hopeful to further boost its membership in 2017.

Other goals for 2017 will be consolidating and formalising the working relationship with the Commission and Regulators, establishing fully functional Working Groups and raising the profile of every example of influence and delivery from the work that is being done by the Avicenna Alliance and its members, from webinars, through collaborative projects, internships and placements and publications.