EMA primed for action
30.06.2016 - We all know about the incredible amount of time it takes to bring a novel therapeutic to patients and the market, and the eye-watering cost associated with that process. It has broken many a person and richer and better than you or I.
The European Medicines Agency has introduced a new tool, called PRIME (like a TransformerTM) that can hopefully help applicants to accelerate approval, particularly those in advanced technology areas or where no treatment is currently available. As the world gets smaller, it is great to see that they nicked the idea off the Americans, as it reflects the Breakthrough Therapy programme over there which has been running at the Food and Drug Administration since 2012.
PRIME (PRIority MEdicines) will offer selected programmes early and 'proactive' support with the aim to get registrations achieved after 150 days rather than the usual 210 – 60 very valuable days for both patients and patent holders. Not everybody can use this – you have to demonstrate potential to benefit patients with unmet medical needs based on early clinical data. However, once you have been picked, you get continuous support to build your marketing authorisation application, meeting with multi-disciplinary experts and receiving advice at key milestones including from Health Technology Assessment bodies.
This is good news for small companies, where cash is king and friends with money are hard to come by. Acceptance into PRIME is a strong indicator of investment and partnering potential, helping de-risk highly novel potential therapeutics for larger companies which roll their eyes like a terrified horse at anything not shaped like a sugar cube. It's also good for Europe's translational research landscape, making it easier to take truly innovative ideas from the lab into development. Hopefully it will contribute to brains, money and momentum entering the pipeline.
And of course it is better news for patients - PRIME goes straight to those hard to reach spots and there are plenty of people there who won't get another chance of a novel medicine. To have something genuinely different become available when all you had hopes of was a reformulated 'something' is something that will sustain patients and their families in tough times.
With the close of recent calls from Horizon2020, which included advanced biomaterials for the treatment of neurodegenerative disorders, it looks like PRIME will be very useful. Medical research is combining the outcomes from breakthroughs in disease understanding with an increased ability to manipulate biology and merge it with many other technologies for the creation of medicines that boldly go where no medicines have gone before (always end with Star Trek if you can).
Make it so!http://www.european-biotechnology-news.com/people/heard-in-brussels/2016/ema-primed-for-action.html