PREPARING FOR SUCCESS:

UNITED STATES

The NDA Accelerator launched in style with a dedicated pre-launch event focused on engagement and approval strategies for the US FDA.

The speakers: Thomas Lönngren, Kim Forbes-McKean, Laurie Smaldone-Alsup, Johan Strömquist

Friday the 18th, the last work day before the official launch of the NDA Accelerator, over thirty drug development professionals and senior leaders of Swedish biotech companies met in central Stockholm to discuss approaches to the US market and celebrate the launch of the NDA Accelerator.

The presentation room was crowded and expectations high as former EMA Executive Director Dr Thomas Lönngren started the day off by going through a number of differences and similarities between the EU and US regulatory agencies. A presentation peppered as much with anecdotes as to how the trans-Atlantic collaboration between the two agency giants came to be, as with facts and figures around the state of regulatory approvals and performance today, got the event off to a fabulous start.

NDA’s CMO/CSO, Dr Laurie Smaldone-Alsup, picked up the baton and covered how the FDA is viewing and implementing expedited pathways – in practice. This session looked as much at the actual practice of granting Accelerated Approvals, Fast Track and Breakthrough Designations, as it explained the main criteria of gaining them. Using several recent examples of companies that have been awarded different designations and challenging the audience to provide motivation as to why those companies and those assets had succeeded, she got the whole room thinking about what characterises successful applications.

This was then followed by Kim Forbes-McKean, General Manager of NDA’s US operation, who walked the audience through how to best prepare for and manage face-to-face interactions with the US regulator. This session touched on formal preparation steps but really delivered when it came to hands-on, practical advice on how to prepare the team and manage the interaction on site.

NDA’s CEO, Johan Strömquist, then introduced the NDA Accelerator. The idea of a membership based portal for thought leadership, training resources and service provision got very positive reception from the whole audience. The fundamental ideas that knowledge must be shared for science to flourish and that we must continue to disrupt our own business models as service providers was met with nods and excited comments.

“NDA Accelerator is the Netflix for drug development advice”

Johan Strömquist, CEO, NDA Group

INTERMISSION – AKA LUNCH

Following a tasty lunch prepared by the talented and service minded people from 7A near Stockholm Central where the event took place, Laurie Smaldone took to the stage again. This time she was joined by our secret guest, Nikolaj Sorenssen, CEO of Orexo.

In a thought provoking fireside chat the audience was guided through the mine field of PBMs and financial incentives that litters the path to the US market. Through Nikolaj’s and Orexo’s first hand experience the audience learned about the importance of understanding their stake holders, regardless of market, in great detail, and not to believe that experiences in one market can be so easily transferred to another.

Orexo’s experiences, success and great potential in the US market give us hope for more Nordic entrepreneurs to find similar opportunities in the lands on the other side of the Atlantic.

Laurie continued by guiding us through pitfalls of regulatory interactions in a highly interactive session that really put the audiences senses and sensibilities to the test. Based on real cases curated by the FDA themselves we were asked to identify appropriate responses to a number of more or less challenging scenarios.

Although some of the scenarios seemed pretty straight forward, it was clear that just a modicum of discussion brought whole hosts of complexity to the surface and gave everyone a lot to think about.

FINAL WORDS

Johan Strömquist then returned to the stage and took the audience through the ways that the FDA is funded and what this means in terms of user fees for applying biotech companies. Fortunately for everyone in the room, Johan further showed how the FDA applies different types of incentives, such as user fee waivers to stimulate innovation. Ensuring awareness of these opportunities seemed particularly important as the application fee for a full dossier in 2020 is very close to €3 000 000.

During the wrap-up of the day it was clear that this type of meeting is viewed to be very valuable among the audience and we at NDA will naturally assess any opportunity to provide similar experiences to the biotech community going forward as well.

In conclusion we believe this was a remarkably successful first NDA Accelerator event and we can’t wait to hear back from attendees to figure out what we should do next!