There has never been a more pressing need for pharma to be in digital, as existing technology starts to come into its own and newer categories begin to offer truly disruptive healthcare benefits.
Insights derived from the right data are at the forefront of this, tying together trends in mobile health, wearables, regulatory needs and even innovative approaches to partnerships.
Meanwhile, a source of technology disruption that’s unique to the pharmaceutical industry is the emerging field of digital therapeutics. Rapidly maturing, the category looks set to offer substantial clinical benefits and a true source of medical disruption.
A welcome boost for digital health technology came from the US Food and Drug Administration with its Digital Health Innovation Action Plan, and in particular that plan’s Software Pre-Certification (or Pre-Cert) Pilot Program. Nine companies were picked in September 2017 to take part in the programme, with Roche and Johnson & Johnson lining up alongside the likes of Apple, Fitbit and Pear Therapeutics.
The initiative looks to marry the iterative design and development seen in the software world with the FDA’s traditional oversight processes. To do that, it will adopt a more streamlined regulatory process for companies that have demonstrated “a robust culture of quality and organisational excellence” and are “committed to monitoring real-world performance of their products once they reach the US market”. But, as the real-world monitoring requirements suggest, it will be a process of adjustment on both sides.
That’s not to say that they have to rigidly adhere to the way pharma works, but there’s certainly a need for a highly collaborative approach and the generation of data that people will believe, albeit in a way that makes sense for the technology.
Meanwhile, wider uses of health technology are being shaped by broader societal forces, with often scary results. “There’s a convergence of a number of different things that are disrupting existing technology,” says Alex. “As an example, the use of social media has had a push-back this year, and from a health perspective there’s a shocking amount of misinformation (as can be seen with various anti-vaccines campaigns).” He says there now needs to be some kind of recalibration in this respect.
Whether, as Apple CEO Tim Cook believes, regulation of social media is inevitable to protect users and their data, it’s certain that data in its widest sense is a key driver for digital health and pharmaceutical companies alike. Witness the enormous efforts within Roche on data systems design over the last few years, which saw it add first an open data platform and then acquire the data-rich European diabetes start-up mySugr.
More fuel for its machine was added recently via a partnership between Roche Diagnostics and Novo Nordisk. This will essentially see the diabetes leader input data from its connected insulin pen into Roche’s open platform and is quite a coup for Roche’s open ecosystem.
“There’s a clear, big data strategy at Roche that they’ve embarked on and that they’re executing against and it looks like it’s yielding results. It’s a great example of a grand vision in digital disruption that’s actually bearing fruit,” says Skye Hodson, engagement manager at Syneos Health Consulting. It’s also a partnership model that has plenty more development left in it.
For pharma, the opportunities presented from improved use of data include the ability to build a more comprehensive understanding of the patient and their needs, identifying patients eligible for clinical trials, engaging them in more meaningful ways and targeting sub-cohorts of patients where higher drug efficacy might be seen. “The integration of datasets and the impact of putting the patient at the centre of healthcare allows you to build a more holistic picture and make more informed decisions that affect drug development, product positioning, messaging, patient engagement and how all the different pieces of the process come together,” says Skye.
Another standout example from the industry that is well worth keeping tabs on is Abilify MyCite, which combines Otsuka’s antipsychotic drug with an ingestible sensor from Proteus Digital Health that tracks if patients have taken their medicine. Approved by the FDA late last year it marked a digital health first in terms of its tracking system and a triumph for its clinical research team, which faced a unique set of problems – including fundamental challenges of where best to place the skin patch that transmits patient data from the pill to an app and how to optimise the whole end-to-end experience.
From a data perspective, Abilify MyCite, which is approved in the US for schizophrenia and some forms of bipolar disorder and depression, aims to create objective datasets that will assist healthcare professional teams with helping their patients. As Proteus CEO Andrew Thompson noted at Frontiers Health 2018 in Berlin recently: “Adherence is not a defective patient problem, it’s a defective product problem.”
Digital medicine is the first time in 36 years that the FDA has created an entirely new product category and leading that charge alongside Abilify MyCite is the emerging force of digital therapeutics. Pear Therapeutics’ substance abuse app reSET last year became the first FDA-approved prescription digital therapeutic, with claims of improving clinical outcomes, to be cleared by the regulator. And in November 2018 it was launched as part of a commercialisation and development pact with Novartis’ Sandoz unit.
Digital therapeutics and other digital medicines offer a unique source of pharma disruption. Neither suffer from the ‘shiny penny’ syndrome of flash-in-the-pan, style over substance, applications of technology, and both lack a ‘fast follower’ model whereby the industry could look to other sectors to learn from how the technology has been adopted there. Moreover, they potentially offer complete replacement programmes for existing pharmaceutical approaches.
“It looks at the moment as if there are a handful of big areas where you can have that complete replacement,” says Duncan Arbour, SVP of strategy and innovation, Europe at Syneos Health Communications. “One is mental health, where there is still some uncertainty around how some classes of antipsychotic medicines actually work, and their total impact on the patient. Mental health issues are some of the biggest problems in society at the moment and they’re growing. They also cause some of the biggest doubts and soul-searching about what is being done for these patients. For example, I look at what Akili is looking to do with ADHD and the thought that there might be a more transparent treatment that doesn’t involve messing with the biochemistry of a young person with this condition is epically transformational.”
So, it’s no wonder that the UK’s National Institute for Health and Care Excellence (NICE) was asked in June 2017 to assess how digital therapeutics can be used to treat anxiety and depression. Issuing its first digital psychological therapy briefing in January this year, the respected health technology assessment concluded that Servier and Gaia’s online and mobile programme Deprexis should be trialled on the NHS. First launched back in 2007 by Hamburg-based Gaia, Deprexis has a CE mark in Europe as a class 1 medical device and FDA approval for the US.
Another area with clear, though somewhat earlier-stage, potential is voice technology. The likes of Apple’s Siri, Microsoft’s Cortana, Google Assistant and, most notably, Alexa from Amazon have brought this technology into the consumer mainstream in recent years. “When you start looking at the potential of digital biomarkers, the application within these of voice technology suddenly starts to look incredibly real,” says Duncan. “Just like digital therapeutics, it’s an entirely new replacement that’s out there. If Amazon does get its vision and every consumer home is quietly recording conversations, you will be able to do early detection of Parkinson’s disease and a number of other conditions.”
However, despite voice technology being mass-marketed across the consumer sector, within health it’s possible that certain patient groups will find it even more useful. “It’s the sort of application that will find success in niches where a voice-led interface is particularly valuable. For example, people with poor vision and motility issues – for these groups there’s evidence to suggest it’s already becoming a game changer,” says Alex.
Development on those use-cases is progressing apace. In October Boston Children’s Hospital’s Voice.Health hackathon, which also involved Amazon and voice AI firm Orbita, awarded prizes to teams working on managing discharged patients, food allergy preparations and patient intake.
Amid so much substantive digital change, there is much scope for the pharmaceutical industry to harness these developments. “For pharma it’s an opportunity to change how drugs are developed and shape what value they offer to the healthcare system and patients,” says Skye. “Pharma is still a very good source of innovation, but they’ve just been doing that very traditionally and digital technology provides them with an opportunity to shift to new models of doing business and makes innovation more sustainable. So, it’s more about adopting incremental innovation across the whole drug development process, from target identification and validation to finding the right patients and building meaningful engagements with them, all while ensuring you have a continuous flow of evidence to support your claims from start to finish.”
Even to be incrementally successful companies will have to do things in different ways. “As Thomas Friedman puts it in Thank You for Being Late, we are living through an ‘age of acceleration’,” says Duncan. “For pharma to try and catch up with the nimbler start-up companies out there requires a change of systems and ways of working, and the adoption of a continual learning process within organisations.”
Greater participation within digital health ecosystems is a central part of this and getting plugged into local start-ups scenes, as companies from Johnson & Johnson to Bayer, Pfizer and Novartis are looking to do, is a very useful step.
There are, however, strong signs that digital is now getting a seat at the boardroom table. For example, last year Novartis created a chief digital officer role, recruiting Bertrand Bodson, chief digital and marketing officer for Sainsbury’s Argos, a complex fast-moving consumer business. It was a move that swiftly followed GlaxoSmithKline appointing Karenann Terrell, Walmart’s former chief information officer, as its chief digital and technology officer.
Skye Hodson, an engagement manager in the Commercial Strategy & Planning Practice at Syneos Health Consulting, has 6 years of multi-sector experience that has seen him not only shape strategies but also ensure their successful implementation. He specialises in supporting the commercialisation of new and disruptive innovation, working across healthcare systems and the lifecycle of assets, with a particular focus on digital strategies and digital therapeutics.
Alex Brock leads digital for communications across Syneos Health Europe, and runs the central digital team based in our London HQ.
He has worked at Syneos Health for the past six years, overseeing the evolution of digital insight, strategy and optimisation across the business. Prior to this he has worked in various insight and digital strategy roles in healthcare and consumer sections over the past 13 years.
Duncan works in the Innovation team within Syneos Health Communications. He has been with Syneos Health for the last six years and has had an exclusive focus on life sciences for the last 11. Prior to healthcare, Duncan spent a decade in senior strategy roles for some of Europe’s leading digital agencies including DigitasLBi and Syzygy, leading projects for clients in sectors including financial services, automotive and government. In the wider industry, Duncan has been an advisor to the UK Government’s Creative Skills Council, and is a frequent speaker at industry events.