40-41 - Responding to the explosion of mobile & digital health across international markets

The prioritisation of process digitalisation during the COVID-19 pandemic is one of a number of positive developments to have emerged from this challenging period in people’s lives and for the life sciences industry.

With so many traditional interactions disrupted, reliance on digital channels for conducting consultations, managing treatments and measuring outcomes has been both inevitable and, in many cases, welcome. It has allowed many services to continue, and it has highlighted the multiple benefits of digital health, paving the way for a future in which manual processes and a lack of end-to-end insight will hopefully play an ever-decreasing part.

Over the last 18-24 months, circumstances and innovative thinking has led to the transformation of a whole range of scenarios harnessing the latest technology and digital information flows. These have spanned everything from patient engagement and recruitment, to continuous health monitoring and remote treatment, using smart medical devices linked to apps or online portals.

Inspired and encouraged by the benefits this has brought, life sciences companies must now lean into that trend – especially as healthcare markets continue to plan for the new normal and the part that remote care and monitoring will continue to play in ongoing treatment models.

This is a global opportunity, too. One of the pandemic’s striking effects has been its universal impact and disruption of ways of doing things, so the scope for multiplying the benefits of associated innovation internationally should not be overlooked.

The FDA’s Digital Health Center of Excellence in the US sets out many of the modern opportunities for healthcare transformation through the use of digital innovation.

It is actively championing many of these – in the context of improved collaboration between different healthcare stakeholders, for instance (life sciences companies, regulators, primary and secondary care providers, etc). Opportunities here include sharing the latest insights and defining ways to accelerate access to effective treatments, as new knowledge is amassed at speed during this continuously evolving global situation.

Other examples include the application of artificial intelligence/machine learning to derive and respond to new and important insights from the vast amount of real-world data generated during the delivery of healthcare every day, particularly involving connected medical devices. As this potential is harnessed to beneficial effect, it could enhance the future role of medical devices.

We’ve already seen the power of data discovery for discovering important new correlations/indications during the pandemic – not least in the potential of a cheap asthma treatment (budesonide) to alleviate the symptoms of coronavirus infection in some cohorts.

Such discoveries pre-date the current pandemic, in fact. Some years ago, a cross-comparison of huge volumes of data highlighted a correlation between Botox use and reduced migraine symptoms in patients (Allergan made this discovery after pulling its diverse safety data into a data lake for extended analysis). Subsequently Botox has been found to effectively treat a whole host of conditions from depression to heart issues.

While some of these discoveries might have been arrived at incidentally, the ability to bring together and cross-analyse high volumes of data at high speed/in real time is enabling step changes in medical advancement. The ability to harness data lakes, data cleansing tools and cloud-based analytics is enabling life sciences/healthcare teams to spot new trends that are helping them stay ahead of medical risk. Although much of the enabling data has existed before now, its ability to provide transformational insights has been restricted by inconsistent ways of recording and storing that data, which have made it difficult to combine and cross-analyse data reliably and in a practical time frame. Defaulting to a digital data flow has changed all that.

Beyond basic research and biomarker studies enabling novel targets for products, the digital transformation of information handling and access is also transforming drug development and trial activity, as well as patient engagement.

During COVID-19 vaccine trials, where speed has been paramount, digital recruitment, patient form-filling and process automation has accelerated the process of candidate recruitment, patient reporting and regulatory risk management. Digital platforms such as online forums are also giving patients more of a sense of involvement in their own treatments and outcomes, improving their trust in and engagement with drugs.

The pandemic has also focused regulators and life sciences companies on the wider benefits of using data including real-world evidence to speed up processes from securing full health authority approval for a product, to improving drug formulations.

Amid all of this potential there are some logistical and strategic challenges, however. To really see the benefit of digital process management and related insights on a global level, it should be possible to look at situations and opportunities holistically.

Yet a one-size-fits-all approach rarely works across international boundaries. Rather, approaches and content must be adapted to suit each market, culture and language, so that services are consistent and reliable for all patients. This isn’t just about the language and phrasing used, but about units of measurement and other reporting elements that need to be localised.

There are regulatory considerations, too, which will inevitably extend to all healthcare data capture/touchpoints. Non-medical device manufacturers including smartphone companies, for instance, will need some form of control/approval if they are recording and submitting health data from heart rate monitoring and so on. Without a doubt, a medical device linked to an Apple Watch or similar via an app, which can update a physician about an individual’s status, has an important role to play in keeping patients well and transforming their daily lives and peace of mind. However the regulators need to catch up with the potential and maintain an environment which maintains patient safety and privacy. Regulator taskforces are already discussing and progressing suitable measures, but this will take time.

In the meantime, the challenge for healthcare innovators is how to manage all of the content, data and insights across multiple jurisdictions, cultures and languages. Whether the focus is international clinical trial activity, patient monitoring, safety/pharmacovigilance reporting, or scientific discovery (eg novel indications for existing products), companies need to be able to compare and make sense of all data, however it originated, and know how to handle and process it in line with local expectations.

Every population has its own expectations and experiences of medicinal advances, too and patient engagement can vary considerably around the world – just look at the relative take-up of COVID vaccines.

In the 1970s, a clinical trial in Puerto Rico uncovered the unwelcome side effect of sterility with a new drug. Such was the fallout from the experience that, almost 50 years on, local populations – and even linked communities in the Bronx in New York – are still averse to participating in clinical trials.

Knowledge of this history, coupled with strategic use of digital platforms and/or mobile apps, can help to reverse these trends in patient engagement and build confidence in drug safety by fostering positive relationships and educating populations at a personal level about all the positives around a new treatment, and the latest medical progress.

For drug companies, the opportunity to encourage patients to ‘follow’ a drug online, join a patient forum or community, share their experiences and meet people with the same condition, is a very powerful proposition.

However life sciences organisations take their digital initiatives forward during and after this next stage of the pandemic’s evolution, maximising potential requires that brands seek appropriate guidance and support as they navigate both the global opportunity and the intricacies of individual markets.