The drug development process today increasingly starts in collaborative environments, incubators, start-up hubs and is supported by industry organisations with growing political clout. Over the last few years Sweden BIO, the Swedish Life Science Industry Organization, has grown to more than 260 member companies, 25% of which are biotechs.

These companies are increasingly resourced thanks to new sources of financing from international partnerships and the successful Stockholm Nasdaq stock exchange. 2017 saw Scandinavian life science companies raise $2.2 billion, doubling from 2016, with strong growth across IPOs, refunds and venture funding as reported in Industrifonden’s report “Scandinavian Life Science Funding Report 2017”.

The soil for growth and development of the vibrant Nordic biotech clusters has never been more fertile than it is today.

A couple of years ago estimates suggested a global drug pipeline of around 7 000, a significant number that has only strengthened since. Over 5 000 of these originate from the United States, and the Nordic contribution is in this context limited.

Given the nature of these different communities this comparison is of course not an apple-to-apple exercise. There is however a lot for Nordic life science companies to learn from their peers across the Atlantic and there is plenty of inspiration to be had by looking at the way that the biotech eco system in the US has evolved and developed. At NDA, these experiences have been plentiful and also been brought to Nordic biotech companies in different, constructive ways.

ACCELERATING DRUG DEVELOPMENT

With the increase in Nordic biotechs comes a need for service providers to change the way they serve this important segment. During a recent survey of small companies in Sweden, it was made clear that flexibility, cost effectiveness and a helping hand – throughout the development process – are requirements that many companies are looking for as they select their partners, consultants and experts.

A company with deep pockets will almost exclusively aim for speed and accolades of expertise. A less fortunate, or earlier company, has other priorities – this should be obvious, but it can sometimes be difficult to appreciate the differences in appetite between companies that on paper look pretty similar. New approaches from service providers and experts are therefore required to adapt and stimulate development in these different kinds of organisations given their particular requirements.

Acceleration strategies and the ability to do a lot with a little is something that most, if not all Nordic biotechs are looking for. Through NDA’s service lines companies get access to world leading expertise to support regulatory strategies, pressure test clinical development programs, manage regulatory procedures and help setup necessary quality management systems to oversee it all.

Acceleration is strategic – choosing targets, products and populations that can be accelerated – but it is also very much tactical. Once you have the right target you must navigate the regulatory maze through delicate management of both procedures and regulatory interactions. You must ensure that your plans fit the regulatory and payer frameworks. Without a strategy there’s nothing to operationalize, but without impeccable execution even the finest strategy can fail.

Working with partners with a strong international reach translates into strong, tangible value. By working with one regulatory partner the drug development program is de-risked, strategies vetted, and outcomes assured. This is true whether the ultimate goal is marketing authorization or out-licensing to a partner.

The end goal is always to see the patient treated. This is why we are all here – to minimize the delay to get that wonderful innovation into the hands of the physicians and into patients to improve their lives. This is important to remember, even if your company is targeting an exit before then. The next company to take on the product will have this top of their list and it will determine its value as you pass it on.

The NDA Accelerator is a new way to serve small biotechs, providing access to thought leadership, expertise, guidance and hands-on support, and resources to train and strengthen teams of drug development professionals.

We keep developing the NDA Accelerator to meet the needs and requirements of small biotechs and are always looking out to learn from the companies and professionals we serve to ensure we continually meet their needs.