Elements for Success in Digital Health for Industry

Interview Transcript: My name is David Radwaner and I’m a senior consultant with IDEA Pharma. I have the pleasure of introducing to you, and speaking with Alicyn Campbell today who is the recipient of this years CNS innovation index award, on behalf of AstraZeneca. Alicyn, congratulations, to your team at AstraZeneca for the win and the great work this past year. I know it's very well deserved.

1.???? AZ has been very successful over the past year in leveraging digital solutions. What, from your perspective, has AZ done well or differently compared to other pharma companies in these last few years in order to achieve this success????

?It’s a great question David, as I think if you look at and consider the words “digital,” “pharma” and “success” and consider the news over the last year those concepts could feel orthogonal vs connected.

However I think our success is based on these 3 pillars combined with resilience and a relentless focus:

(1)?? We invested in digital health, including hiring the best talent, committing resources and integrating it into our portfolio in a meaningful way.

(2)?? For Oncology, we set out and stuck to singular vision: to leverage emerging technologies to increase the evidence base for our medicines and pull those beyond the trial into the routine care setting to improve care for all patients.

(3)?? We focused on digital solutions that delivered a clear link and ROI to our portfolio not only in terms of documenting treatment effect and tolerability, but also applying technology to accelerate trial cycle times. We have focused our efforts on developing integrated, end-to-end, scalable solutions that support standardizing ways of designing and managing trials, simplifying the site experience and reducing the delivery burden in the clinical environment. So a clear focus in SCIENCE and CAPABILITIES in tandem.

We have internally built digital solutions that include a DCT platform, a study design and planning tool, and a portfolio management dashboard that all apply digital and advanced analytics to increase data visibility, efficiency of how we bring new drugs to market.

?We have a strong multi-disciplinary team that has deep experience spanning technology strategy and development, design, digital product development at the intersection of hardware and software, and core scientific capabilities such as data science, AI, measurement science, and behavioral science, and we’ve double downed on areas where we were superior and differentiated from tech and industry.

?But, it's not just our Digital Health team that drives this success, as fundamentally, the entire AstraZeneca organization sees the enormous opportunity for digital health. This is something we’ve done as an R&D organization, across all functions, together.?

2.???? What has your experience been like, as a head of digital health oncology R&D within AZ? – how has your role evolved over the last few years??

?I feel really privileged every day to lead such a dedicated and exceptional team of amazing scientists and technologists, it gives me endless energy! I firmly believe that great ideas come from great people, and by creating a fun, safe, mission driven environment where individuals feel empowered to deliver their best work, that we have and will continue to build and deliver amazing solutions that support patients, physicians and the wider sector. Provide a meaningful vision, like transform the assessment and treatment of cancer, bring amazing thinkers along with you, give them autonomy and a place to advance their best ideas, have a clear goal the team can align around.

?My role is constantly evolving as the Digital Health space evolves and advances at pace.? Through digital and AI, we have an opportunity to reimagine how we design endpoints, from data inputs through to analytics and how we and build and deploy algorithms as part of our bespoke digital products.

?Although we initially focused on novel digital therapeutics, and have one in late stages of development for a low prevalence high morbidity side effect of over 44 cancer therapies, we’re constantly reviewing the portfolio and the landscape for opportunities to create digital adjuncts that can be used alongside our medicines and any medicine with a similar tolerability profile. We’re increasing our focus on remote patient monitoring solutions as there’s an unmet need for tools that combine a patient’s physiologic signs and symptoms with management guidelines and HCP dashboards to increase the quality and efficiency of care, but also keep patients on treatment longer; reducing their suffering from side effects of therapy and maximizing therapeutic effect.

3.???? What have you learned over these last few years??

The last few years have been eye opening in terms of joining 2 weeks before covid lockdown in 2020, quickly seeing behaviors and acceptability alter, and technology and computational power scale at pace due to the externalities of the pandemic. All of a sudden patient and provider and even payer willingness to engage w digital aligned with advances in connected devices and the ability to collect and process vast amounts of data at scale.

It demonstrated that through digital and data, there is an opportunity to accelerate earlier diagnosis and treat for better outcomes. But, this is an urgent time to act, as more patients are expected to be diagnosed with later stage diseases and cancers following years of delayed care during the pandemic. We are working in partnerships with tech collaborators, academia, advocacy groups and governments with the aim of finding and treating chronic diseases and cancer earlier, detecting treatment progression earlier, digital detection and treatment methods are integral to these efforts.

4.???? Anything you think was done poorly early on by industry, and how were you able to correct or overcome these initial missteps??

I think within industry, digital and tech there is a propensity to want to include “digital for digital’s sake.” Even say the word digital and semantically you will find varied interpretations and definitions of what it encompasses. When I was first approached for this role in late 2019, I was spurious as historically digital groups in pharma were the teams that “tossed a sensor into a study” because it was new or cool but was not linked to patient relevant concepts or an assessment of treatment effect. So based on discussions w Mike & Clare Rea at JPM 2020, I chose to take on this role and apply a different approach, a much more quantitative, scientific, and rigorous approach. I have to say, seeing the amazing AZ digital health team combining best in class science and capabilities winning the Innovation award this year demonstrated to me personally that the time, and focus and dedication to our mission was absolutely worthwhile.

So what does successful digital look like? You should always start with the outcome of interest to assess in patients in the population under study, then consider what endpoints you should construct to assess that outcome of interest. You should apply the estimand framework , that should be used for all endpoints, and identify intercurrent events or aspects of your design that could impact the analysis. Then you should choose the most appropriate, rigorous and reliable tool to assess that outcome of interest...this could be a COA, a connected device, a composite biomarker… Digital teams have been in Pharma for at least 8 years now and I still observe digital health tech companies and pharma teams getting this backwards and starting with a device instead of the outcome. In my opinion, it does a massive disservice to the patients we serve when we’re not thoughtful about our assessments and the data we collect from them as part of a trial or as part of routine care.

?Our team’s also been successful as we’ve not only doubled down on the science, we consistently started with patients. If you want to improve the clinical trial experience or design a trial you need invest effort to understand patients’ experience and perspectives.? We’ve generated qualitative research from thousands of patients, caregivers, and trial investigators from 9 countries to understand their experience of their disease as well as their experience of participating in clinical trials. If you want to learn more, please check out a recent paper by Duran et al , co-authored by myself and other AZ senior leaders that discusses benefits and case examples in Nature.

?5.???? As most of us believe digital is likely to continue to transform the healthcare ecosystem, what do you think Pharma’s role in this transformation will, or should be (i.e., how should -or can- pharma facilitate this transformation)??

?As a sector, we need more leadership, investment, collaboration and integration, less fragmentation. Regulators, patients, providers, sites do not want multiple apps and solutions from every pharma & tech company. I think there needs to be consolidation under the best-in-class solutions and products to create more unified approaches in how we all develop and deploy digital technology. We need to work together more, either pre-competitively or with novel models of partnership.

?Digital solutions should help automate, streamline and simplify – this is true in every industry.?Healthcare is still quite fragmented in its approach to digital. We can all agree we need integrated, end-to-end, scalable solutions, and this means thinking about how we integrate into health systems across geographies and how our tools can be additive to their workflow increasing the efficiency and quality of care delivered alongside our medicines.? There’s a massive opportunity for the solutions we’re building to be integrated into large health systems who are also keen to assess and track patient outcomes for cross institution comparison. Usability affects not only efficiency but also the willingness of people to work with digital tools that do not fit into clinical workflows and do not assess a patient’s experience of treatment and disease in ways that’s relevant to them.

6.???? What kinds of digital technologies do you think are appropriate or good fits for Pharma companies to be leveraging, or developing themselves?

The opportunities are really endless when considering leveraging empiric evidence to document treatment effect. Digital health tools have a role to play across the whole treatment development lifecycle.? From transforming how we conduct our clinical research, to improving the patient experience and providing clinical evidence of the safety and effectiveness of new treatments.

?As a global, science-led, science driven biopharma company I feel we bring a unique perspective to the development of end-to-end digital health solutions, from scientific concept and endpoint development to designing and delivering clinical trials on our novel DCT platforms, and understanding how best navigate the complex regulatory landscape.? We’re also in a strong position because of data. We run clinical studies that include over 120,000 patient every year. This is a massive opportunity to include, collect, analyze and refine these technologies that no technology company would have access to. It’s why our team has been so successful, maximizing the opportunity and leadership role we have from having access to data.

?We also bring a deep understanding of the healthcare sector and clinician, and patient needs. We have developed a gold standard model for patient engagement working in partnership with organizations such as Savvy, University of Dundee, Spoonful of Sugar and Instinct Labs, to understand feedback on our tools to make sure they offer a good experience and support achieving the best outcome.

?We have a number of home grown solutions including our patient and physician app Unify, which is a digital app and clinical trial support tool that is able to virtually connect all study participants whether through engagement with patients and caregivers, via data collection in real-time through to streamlining the experience for sites, when we combine this with best in class science building our novel digital therapeutics, endpoints or remote patient monitoring tools we’re in an extraordinary position as we have the data from our trials to build these tools and document their effect.

?For patients that struggle to participate in trials due to limited resources or time, our digital solutions enabling expanded access to existing treatments & clinical trials and have the potential to improve health quality of life and increase better health outcomes, while also increasing the scale and heterogeneity of individuals who are able to participate in clinical research leading to the approval of medicines tested in more generalizable populations.

7.???? To wrap up, what are you most excited about & looking forward to in the future for yourself, AZ, and for the space in general

?For me: the continued evolution of products at intersection hardware & software, especially new and more refined FDA cleared Bluetooth devices we can integrate into our end-to-end digital solutions. We need the technology to accelerate to effectively document the physiologic signs and symptoms that matter most to patients in a low burden way. Also the opportunity to expand analogs from oncology into rare disease. And finally bringing our late stage DxTx to the market to reduce morbidity and improve outcome for millions of patients. It’s what motivates and drives me every day. (and personally I am looking forward to some longboarding in California over the holiday break)

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