Prime – The European approach to expedited pathways

By: Steffen Thirstrup, Director, NDA Advisory Board & Eva Lilienberg, Principal Consultant 


Steffen Thirstrup, Director, NDA Advisory Board

A timely market introduction is a critical component of any drug development strategy – not only from a commercial stand point, where an early introduction can mean beating competition to market or simply significantly increased revenue, but also to patients awaiting better or alternative treatment options.

The debate around how regulators can facilitate this process on both sides of the Atlantic has resulted in new pathways for new medicines of major public interest. The FDA have the Breakthrough/RMAT pathways, and in the EU, EMA has put the PRIME process in place.

In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.

To read the full article download the PDF

Download PDF

How we can help?

NDA Group supports life science companies all over the world with the aim to streamline the global development and commercialization process in order to accelerate patient  access to important medical therapies.

Whatever regulatory hurdle you’re facing, we can help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.

To learn more about our services and how we can help click here

Or contact us at meet-us@ndareg.com to talk to one of our experts.

Athersys

Athersys is a US-based clinical stage biopharmaceutical company with a growing pipeline of therapeutics to treat significant and life-threatening diseases. To ensure the global success of its drug, it was necessary to broaden this clinical trial programme to include Europe. However, the company recognised the need for specialist regulatory support to advise how to best approach this region.

Top 10 Pharma

To get its drugs to market faster and reduce the cost of developing new medicines, the company recognised the need to change the way it was approaching its whole development and approval processes for new medicines. The company had traditionally always addressed the regulatory and HTA requirements separately, and over two stages. However, it realised this was no longer an effective way to work. Having worked with NDA Group for a number of years on the regulatory side, the company was interested in NDA’s consulting service to provide joint advice on gaining regulatory and HTA approvals in Europe, called NDA Joint Advice.