Patient & Pharma Summit Europe Virtual

Sep 15, 2020 - Sep 16, 2020, Digital Conference, Networking & Exhibition

This is the only event you need if you’re looking for hands-on industry examples, the critical success and challenge factors, and the answers to issues ranging from compliance to culture. No more theory, time for action.

Patients and RWE: Is this the year?

There is reason to hope that the long-awaited breakthroughs flowing from patient-generated data are about to happen

The long-hyped redefinition of healthcare through wearable tech has been… well, long hyped. Early projects, such as Apple HealthKit and Fitbit, were undoubtably important in redefining ‘the possible’ but they haven’t yet achieved transformative application. 


Much has been written on why the philosophy that has driven the astonishing success of consumer technology doesn’t translate to healthcare and when we look at the state of innovation in 2020, many of these structural issues remain.  


As Emily Cerciello, Associate Director, Digital Health and Engagement at the Crohn's & Colitis Foundation states, “The technology is way ahead of where we are in healthcare, the real challenge is being able to operationalize it. It is more of a logistics bottleneck. All of this needs to catch up, we need to work out who is paying for it and who is leading it for this to be adopted at scale.” 


However, when we take a look at the glut of maturing projects within this space, there is reason to think that 2020 could be the year that stasis breaks.  


Areas for innovation

The US healthcare industry continues to advance value-based models, changing the structural conditions for wearable innovation. In principle, value-based care requires pharma to deliver efficient R&D, demonstrate value and ensure that medicines have maximum impact. All of the above must be fueled by patient data.


The FDA has a big a role to play in both creating demand and enabling supply here, and the 21st Century Cures Act is proving a catalyst for a progressive attitude at the agency. Importantly, this has enabled patient preferences to become incorporated in drug development. 


Underlining the significance of this for patient access, Angela Dobes the Senior Director, of the IBD Plexus program at the Crohn's & Colitis Foundation states, “Historically getting FDA approval was the big win, but today it is about showing value evidence to get on formularies to get treatments prescribed. RWE can now be used to better incorporate outcomes data into value-based decisions to enhance access to care.” 


Dobes highlights Rituxan Hycela as a landmark example, which actually incorporated patient preferences from clinical trials within the label. With a clear pathway established for RWE use in label expansion, this has been a key trigger to drive demand for patient data within industry. 


Native capabilities

As the momentum and interest within industry has slowly started to build, the underlying technology for wearables has continued to improve, progressing into new areas. A big trend has been to maximize what can be achieved with native smartphone capabilities. 


Making data collection as convenient as possible reduces one of the barriers to adoption and, importantly, also controls cost. One example here is the startup Miro Health. It has been refining AI algorithms on phone usage to make startlingly accurate predictions on mental health.


Apple HealthKit has also continued to make moves to position itself as the partnership platform of choice. Apple has sought to make it as easy as possible to build applications using its tools, as well leveraging its position as a common platform to slash costs. 


Not starting from scratch means that when it comes to passing medical device regulation, applications can save the expense of demonstrating manufacturing quality for the underlying device. This offers huge value to pharma players, who can act as knowledge partners without stepping into unfamiliar territory in tech, says Haider Alleg, Global Head of Digital Excellence at Ferring Pharmaceuticals. “This saves money and it means I can just focus on patient experience. If tech companies become data platforms and med device platforms, they become the partner of choice.”


Device Innovation 

This is not the only way forward, however. There are plenty of examples of what is possible through bespoke device design. 


One such pioneer is the startup Empatica, which spun out from the Affective Computing Group at MIT. They created small wearable devices that collect physiological data, going beyond movement and temperature to also include measurements that track output from the central nervous system. This enables them to create machine learning algorithms for new digital endpoints and biomarkers.


Their flagship Embrace2 device supports epilepsy patients, by detecting the onset of convulsive seizures and triggering alerts to caregivers. Chelsea Trengrove, Program Manager, at Empatica, describes the impact this technology can have on patients and caregivers: “I’ve met with mothers who’ve had to sleep in the same room as their child, worried about their child experiencing a seizure in the middle of the night. For the first time in ten years this device has meant that they no longer have to.”


Through a set of advanced sensor capabilities, this class of devices also offers a new depth of insight into disease, by creating dimensional data sets that track health across multiple data points. Trengrove points to stress, sleep and pain as one research areas where this technology could have a big impact. 


Research in these areas has typically relied on patient reported outcome surveys, which ask patients to self-quantify their experience of pain against the dated metric of choosing, such as a representative number/position on a scale. These approaches are subjective, inconsistent, imprecise and as a result, often inaccurate. They also don’t give any real insight to what is going on beneath the surface. 


Trengrove explains, that with an advanced device, such as the upcoming EmbracePlus, it is possible to gather the output of multiple sensors such as heartrate, inter-beat interval and skin temperature. For pharma, access to a greater quantity of higher quality data of this nature could translate into shorter trial timelines. And since this data is collected objectively and remotely, studies can be run on countless participants, without being reduced to specific cultures or geographies.


Patient Privacy

At a time when data privacy is increasingly contentious, a critically important issue is, of course, that patients understand how their data is being used and that they see the value in contributing. 


We asked the Crohn’s & Colitis Foundation how it builds this trust with patients. Caren Heller, the Chief Scientific Officer, had this to say, “When we collect patient data, we are transparent and explicit on informed consent…we have trust and we value this trust and we do everything in our power to protect it.” 


Her colleague Emily also speaks to patient attitudes in sharing data, adding, “Patients also feel good about the contribution to science. Disease management is so important to improve quality of life in conditions like Crohn’s disease and ulcerative colitis. Patients want to know what drug they should be on and when. Contributing RWE could give this information. I’ve had a patient tell me she contributes data because she knows the drug she is currently taking will lose its effectiveness one day. And this is the best way to create the next option.”


Communicating this value clearly to patients to galvanize a participatory attitude to R&D is essential if industry and academic researchers are to realize the benefits that digital data can bring to R&D, says Alleg. “I truly believe in the concept of a digital twin, as a digital replica of the patient which can contribute to research. It will be like the donation of tissues or organs today. The more patients donate data to help, the more effectively we can do clinical trials.”

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Patient & Pharma Summit Europe Virtual

Sep 15, 2020 - Sep 16, 2020, Digital Conference, Networking & Exhibition

This is the only event you need if you’re looking for hands-on industry examples, the critical success and challenge factors, and the answers to issues ranging from compliance to culture. No more theory, time for action.