Drug delivery
cost. “We’re making sure we don’t just get half of the benefits of a drug,” notes Østergaard. Of course, ensuring even a simple app like the one Novo Nordisk is trialling for diabetes meets regulatory requirements and patient needs is a much bigger ask than making a typical habit tracker or calculator available to download. “It’s simple to understand and simple to programme,” admits Østergaard, “but what we have to do is comply with a lot of documentation to satisfy regulatory authorities that this is safe and tested before we give it to patients. “That’s the team we’re setting up. The hard part is not the coding: we could probably code the app in two weeks. But testing and ensuring that it’s safe and documenting exactly how it works so we know that it is safe in all situations – that takes a long time.” For Østergaard, that means melding a tech culture that valorises moving fast and breaking things into a pharmaceutical one that has absolutely no tolerance for mistakes or failures that could result in patient safety issues. He compares the plight of a digital therapeutic developer with that of early social media entrepreneurs. Although Mark Zuckerberg (the originator of the ‘move fast and break things’ credo) specifically made Facebook for university students, there was no requirement for him to concern himself with the dangers – and the stresses – that could arise from its use by the rest of society. Digital health companies, by contrast, need to obsess over people not using a product for its intended purpose, and either find ways to prevent that from happening, or ensure that no dangerous situation can arise from it. “Basically, we need to find developers that also like to do documentation,” Østergaard laughs. “They’re a little bit hard to find: they prefer to develop.”
Simple solutions
Those difficulties aside, Østergaard is clear on the benefits of the science-led and risk-averse attitude for which pharma is known, and believes it gives companies like Novo Nordisk a clear advantage over tech- and brand-focused start-ups that focus exclusively on digital therapeutics. This isn’t the consumer world, where “80% of people will choose Coke and 20% will choose Pepsi” even though blind taste tests almost always find that people have no real preference for one or the other. “What a lot of these new start-ups are struggling with in digital therapeutics is that they have not proven that they're delivering improved health outcomes, more health,” he explains. By contrast, pharma can use digital therapeutics synergistically within its model of new innovative medicines. “We are saying, when you use our medicines, which have a proven benefit, with a digital therapeutic, then you get more health. That’s what society is
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
interested in getting, so, to have a place in the digital health game, you need to document by proven scientific methods, that, versus, the alternative, your product delivers more health.” People with chronic health issues don’t choose their conditions like they do phones or customise them like social media profiles, so digital therapeutics still need to be therapeutics first. The perceived benefits of being associated with a particular brand – of picking either Coke or Pepsi – are meaningless when it comes to coping with something like diabetes.
According to a 2020 Novo Nordisk-led study, smart insulin pens can increase mean discounted life expectancy by 0.9 years.
“If you’re paying for medicine, you should only pay for something with a real benefit. And it’s the same for society, if they’re making medicines or digital therapeutics available for people to use, it should be because they have a proven effect.”
Søren Smed Østergaard, Novo Nordisk
Østergaard is adamant on this. “If you’re paying for medicine, you should only pay for something with a real benefit. And it’s the same for society, if they’re making medicines or digital therapeutics available for people to use, it should be because they have a proven effect.” If people with diabetes couldn’t tell whether their medicines and therapeutics had a real impact on their health, they’d just be extra stressors. “And it’s not just for Nordisk and diabetes: morally, this is something we should engage ourselves in as an industry,” Østergaard concludes. “From a societal point of view, we need to ensure, especially in chronic disease, that people are optimally using the medicines that are developed to help them cope and live long lives free of complications.” ●
The amount of people with diabetes who noted that their condition negatively affected their physical health. Novo Nordisk
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Victor Mulero/
www.shutterstock.com
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