Closing out 2023

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Many of you may still be relishing in the holiday bliss, but for HealthXL, the new year is already in full swing. Before we properly close the door on last year, I wanted to take a minute (or so …) to reflect on the tumultuous year that has been.  

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To us at HealthXL, 2023 can be summarised in 3 key themes, which not so coincidentally correspond to three report titles we published last year, namely:

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• Pharma 3.0 and how we can do digital health better
• Pharma medical affairs as digital health’s next strategic enabler
• Unlocking the value of digital measures for drug development

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In what follows, I’ll explain why we chose these report topics, outline the thread that connects them, and give you a glimpse into what our community will likely focus on in 2024.

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Digital Health’s Great Turning Point is an Opportunity for Medical Affairs and R&D

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A bright horizon for healthcare in recent years has been the promise of digital health as a means for achieving milestones such as increased access to care, improved patient monitoring, connected health and streamlined workflows. The Covid-19 pandemic accelerated innovation – solutions such as telehealth and digital mental health supports saw unprecedented adoption. In early 2023, the industry as a whole experienced the sober realisation that we’re all trying to launch digital health products for markets that have yet to mature from a digital infrastructure, regulatory and reimbursement point of view. Consequently, achieving scale with digital health has been elusive and has led observers to question the commercial viability of digital health endeavours.

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Pharma has been central to digital health’s journey to the main stage, with many high profile deals and partnerships occurring over recent years. Pharma initially focused on innovation in specific disease areas, concentrating on how digital health fits around the molecule. Pharma viewed digital health as a tool to stave off patent cliffs, engage with healthcare systems and add additional value to established assets. While digital health found refuge within pharma initially, the industry acknowledged its struggles to move the needle with digital health initiatives amidst fragmented and change-resistant healthcare systems. Many healthcare systems are simply not ready yet to use pharma-backed technology innovation and in many ways, pharma’s success with digital health will always be externally contingent. While our first report of the year focused on analysing the root cause of digital health’s woes in the pharma industry, we also offer a framework for how to course correct. In any case, it was not all doom and gloom; the malaise on the commercial side does not necessarily extend to other functions of the pharmaceutical industry. In fact, in many of our community conversations throughout the year, experts and industry leaders repeatedly pointed to the untapped opportunities for digital health in medical affairs and drug development in particular. 

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Why continue to invest in digital health at a time when budgets are shrinking?

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The HealthXL team tackles this question in our report focused on the next phase of digital health in pharma titled, ‘Pharma 3.0: Doing Digital Health Better’. With contributions from over a dozen experts across pharma and digital health, our team analyses the root causes of pharma’s challenges and provides a framework to guide the industry in building stronger foundations for digital health. 

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Access the full report here.

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The Proliferation of Digital Health Technologies in Evidence Generation is a Strategic Tailwind for Medical Affairs

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Historically, pharma has been treating digital health as a separate function of the business, rather than an intrinsic driver or enabler of pipeline or portfolio. For instance, digital health teams are often siloed from other functions within these large organisations, whereas digital expertise is required across the entire value chain. Experts contend that digital capabilities will need to be democratised across molecule teams (and ideally, all the way up to senior leadership). The fact that digital health expertise and skills are not equally or strategically distributed across all functions creates a bottleneck to innovation. 

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The proliferation of digital health technologies (DHTs) in pharmaceutical R&D and the growing integration of DHTs in the patient journey is now requiring medical affairs to take a stance on digital health and make a decision on whether this function could play a more strategic role in how pharmaceutical businesses drive technology-enhanced healthcare. As the owners of data generation strategies in pharma companies, medical affairs have a strong imperative to develop  deep digital health capabilities and skills.

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In discussion with our community members, which served as a precursor for this second report of the year, it transpired that innovation-conscious organisations will need to upskill and expand medical affairs’ core digital capabilities in areas including

• Digitally-enabled patient journeys 
• Digital measurement technologies
• Real world evidence 
• Multi-functional orchestration and end-to-end decision-making 
• Technology scouting and assessment
• Personalisation and automation of engagement

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The future success of medical affairs relies on this function becoming a strategic enabler of digital health activities in pharma. Medical affairs teams have a deep understanding of disease and medicines, they work closely with R&D and commercial and regularly interact with physicians. No other function within pharma is as ideally situated to push for greater uptake of digital health whilst optimally aligning key external stakeholders for adoption. 

Digital health champions within medical affairs and across other functions need to capitalise on the existing momentum and embark on educational and advocacy campaigns to debunk the prevailing old-school mentality and convince this function to embrace technology in a forward-looking way.

Can medical affairs unlock digital health’s full value for pharma?

This report looks at why medical affairs must increase focus on and unlock the value of digital health. As the owners of data generation strategies in pharma companies, medical affairs have a strong imperative to develop deep digital health domain knowledge. 

Access the full report here 

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Willingness to Collaborate on Endpoints will Unlock the Value of  Digital Measures for Drug Development

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The themes of ‘emerging maturity’ and ‘capability gaps’ that we explored in the first two reports of 2023 also carried through into our last report of the year, which we co-authored with Biofourmis. Digital measurement technologies are undoubtedly still maturing; for one, they are not yet commonplace in clinical research nor do they have uniform application across therapeutic areas. Challenges to the more widespread adoption of digital endpoints, including digital biomarkers, encompass multiple issues, ranging from gaps in awareness among patients and healthcare providers, a lack of technical expertise, to regulatory uncertainty and high development costs. A key concern that transpired in this report pertained to the lack of standardisation surrounding measures; without standardisation and a common technology-enabled framework for measuring, disease companies will develop their own metrics for their own drugs, leading to a highly fragmented landscape. The success of digital endpoints, including digital biomarkers, will be contingent on open-source collaborations and the scalability of digital measures. Experts contend that this will require pre-competitive collaboration on the development of truly patient-centric metrics that are decoupled from pharmacologics. 

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Compared to the Pharma 3.0 and medical affairs reports, however, we felt greater optimism writing about the potential of digital health in R&D, in the sense that R&D functions were much more bought into the potential of digital health. According to 21 experts that we surveyed, the utility of digital measures is overwhelmingly recognised in pharmaceutical organisations. While the utility of digital measures is widely recognised, it is yet to be optimised. Experts, however, predict that digital endpoints will support label claims within the next 3-5 years. This is a relatively short time horizon, but one that puts great trust in DHTs.

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How can we unlock the value of digital measures in drug development?

This report looks at how pharmaceutical companies can drive greater adoption of digital measures in R&D. We present an expert-led analysis of the state of digital measures in drug development and review key milestones that have been achieved to date.

Download the report to learn what our HealthXL community experts believe is in store for the future of digital measures in drug development and how best to prepare for it. 

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Opening up 2024

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At the start of 2023, you could have been forgiven for predicting the end of digital health in pharma. What happened last year, however, was a (re-)positioning of digital health as a strategic enabler of the core business in many organisations (with some continuing to selectively explore other digital healthcare endeavours at a scale relative to emergent market dynamics). The turning point of 2023 invited a deeper reflection on the appropriateness of digital health innovation as a de facto tactic. In many ways, this was a positive development for many pharmaceutical companies who are beginning to undertake very focused journeys in digital health. Digital health champions in pharma must capitalise on this momentum; they need to make a stronger case for budgets and upskill their teams. All of this, however, will be in vain if teams cannot catalyse a greater mindset shift and buy-in for digital health projects across their organisations and beyond.

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The opportunities for digital health across medical affairs and R&D are endless, so much so that we’re actively encouraging conversations on these topics in our Q1 2024 meetings framework. For colleagues on the commercial side, we predict a renewed focus on digital therapeutics and evidence-based platforms. Artificial intelligence will power up all facets of digital health and we’re convening plenty of meetings and peer discussions on this topic.

We hope you enjoy the walk down our reporting memory lane. Stay tuned for many more insightful reports in 2024. To check out our upcoming virtual meetings, browse our catalogue of Q1 meetings.