News
FDA to look towards Observer Status in Avicenna Alliance
The Avicenna Alliance has been in touch with the FDA on the issue of in silico medicine over the last number of months and has reached a new level of cooperation with the FDA looking into Observer Status in the Avicenna Alliance. The FDA are quite advanced in terms of Regulation in this field and are looking to the Alliance as potential interlocutor between the US and EU on harmonisation of in silico policy.
Avicenna Alliance review meeting with the European Commission
On 02 May 2016, Avicenna Alliance delegates met with representatives of DG Connect to discuss progress on in silico medicine in the 1st quarter of this year.
EC Appoints VPH to key stakeholder group
The European Commission has appointed the Virtual Physiological Human Institute (VPHi) to its eHealth Stakeholder Group. With VPHi representing 50% of the membership of Avicenna, this provides the Alliance access to a key influential group in Brussels.
EMA Regulation Vote result – major gains for in silico
On 10 March 2016 the European Parliament through an overwhelming majority, voted in favour of requiring the EMA to take into account alternative models in clinical trials. The Avicenna Alliance has been working with supportive Members of the European Parliament to modernize elements of the 2004 EMA Regulation to enable the in silico market and provide certainty for investors and researchers in the in silico community.
EMA PRIME scheme – room for improvement
On 07 March 2016, the European Medicines Agency (EMA) launched their new Priority Medicines Scheme (PRIME) which aims to accelerate assessment of innovative medicines by shortening development time through stronger interactions between industry and the EMA. The scheme has a good number of similarities (at least in terms of goals) as the FDA designed “Innovative Pathway 2.0” which also aims to tackle the long time to market of new therapies.
Over the Horizon 2020
Ignoring the painfully unimaginative title of this article and getting to substance, the planning for the successor to Horizon 2020 is to start soon. This is no small task and to see how the 9th Framework Programme for Research and Innovation might turn out, it is worth having a look at why Horizon 2020 was brought in to replace FP7.
