The swift developments in digital technology in recent years have transformed so many areas of our lives, from education and personal banking, to everyday activities like booking travel. Healthcare has also seen digital incursions, yet the strides made here seem small compared with those achieved in other areas – the motor industry, for example.
Cars contain many sensors that continually monitor performance and notify the owner when something is wrong, points out Ali Parsa, CEO of digital healthcare provider Babylon. And he says the time will come when we will be able do the same in medicine. “We are approaching an area where we will be looking at our biosensors and signals in our bodies that will tell us what is happening in it. We will know the solution to your problem a millisecond after we have received the signal and that information will be freely available to everyone everywhere.”
Such is the huge promise of digital healthcare: experts say it can revolutionize medical progress, but the pharma and biotech industries cannot deliver these advances alone – they need technology expertise to help meet the growing expectations of their consumers. Industry has already begun to team up with tech firms, both niche companies and giants like Google and Apple, to help it catch up and begin to exploit more fully the field’s almost limitless potential. But at the same time, it is acutely aware of the need to negotiate regulatory and security minefields.
Better Late Than Never
Digital health company Qualcomm Life’s vice president and chief medical officer, Jim Mault, is unsparing in his assessment of where the industry currently stands: "Healthcare is still quite antiquated in its practices and delivery and it is one of the last remaining sectors of our economy and our society that is yet to go fully digital.
“The way we deliver healthcare hasn’t changed for 100 years. When we write someone a medication we say take x mg of x medication, but why is every human being getting the same dose of x? Do you really think everyone will respond the same? With digital health, what we will see is personalized care, intelligent care.” Mault said that Qualcomm Life was all about enabling "the internet of medical things" and that this would be the starting point for the "mass transition in healthcare from analog to digital."
If you consider the fact that technology can be lighter, smaller, harmless and dissolvable then I think it’s only natural that pharma asks for help in personalizing medication and healthcare. Perhaps it is time to bring in technology but the question is at what point will pharma be replaced by technology? Is that possible? I think not, but I suspect it'll be more of a marriage of convenience” – Christopher James
So why has pharma been so slow on the digital uptake? One expert, Professor Christopher James of Warwick University and chair of the Institute of Electrical and Electronics Engineers and the Engineering in Medicine and Biology Society (EMBS), explains that when digital health technology was in its infancy, the devices used were still big and bulky, and pharma was too complacent to recognize its need. It was still enjoying enough success doing what it always had done so well, creating pills and jabs, to immediately embrace the potential of the new technologies. "We’re moving away from a blanket approach to medicine," said James. The era of personalized medicine has arrived, the industry has woken up and is now eager to exploit the advances that digital health can bring.
AstraZeneca PLC’s pharmaceutical project director, Matthew Bonam, says his company is enthusiastic about the possibilities. “There are many potential benefits including enabling patients to self-manage their conditions, providing a more complete picture of a patient’s current and future health status to HCPs to support decision making. These technologies, and the data they generate, have the potential to revolutionize care, identifying ‘at risk’ patients earlier and supporting more cost-effective management for populations and improved outcomes for the individuals.”
It’s hard to believe that the use of digital technology would not become an integral part of healthcare delivery, he added. The information collected from digital delivery of health can be used to deliver personalized support for patients, giving them the specific disease and treatment information they need. The same information would be helpful to healthcare professionals to facilitate consultations and support clinical decision making.
For now, though, the field still looks rather less sci-fi than in Parsa’s vision: in healthcare, digital technology principally involves the use of devices to collect various types of data to store in a cloud and make available for use by various stakeholders such as pharma companies, healthcare professionals (HCPs), patients and caregivers.
Its first applications have included the more obvious low-hanging fruit of patient adherence. Without technology, it can be very difficult to tell how well a patient is taking their medication. As James explains, "You can put pills into boxes marked Monday, Tuesday, Wednesday etc., but if the box is empty, it doesn’t mean the pill has been taken. It could mean the dog ate it or it was flushed away." Only technology can provide a real idea of what patients are doing with pills and their true effectiveness, he believes.
Novartis AG's global head of digital medicine Amy Landucci added that compliance was a huge issue, particularly for chronic diseases. Not only could sensors in pills track adherence but also other physiological measures that will give HCPs an idea of whether or not the medicine they are prescribing is working, she said.
Chronic respiratory disease, in particular, is one area where big pharma companies have concentrated their initial efforts in patient adherence, and it is here where they have already inked deals with specialist firms.
Novartis, Teva Pharmaceutical Industries Ltd., and AstraZeneca, for example, are all looking at tracking patient adherence with their inhaler-delivered products. Teva’s global head of respiratory medicines Sven Dethlefs says that poor adherence to treatments for chronic diseases, such as asthma and COPD, is a “worldwide problem."
Landucci admitted that to get ahead in this space, Novartis saw partnerships as the way forward. "We are not looking to build capabilities in our company but we are looking for companies to partner with." Novartis is working with Qualcomm Life to make its Ebreezhaler a smart inhaler that can track a patient’s drug usage, for example. Qualcomm Life is a company well known for its wireless technology. The company provides the connectivity required to help pharma companies develop sensors and therapies to ensure patients are taking medication properly. Its medical-grade 2Net platform uses devices to capture and hold patient data such as blood pressure and weight.
Adherium’s Smartinhaler Product Range
AstraZeneca, meanwhile, has signed a 10-year supply agreement with B2B digital health company Adherium Ltd. for its technology platform that consists of a cloud-based server to collect data gathered by its Smartinhaler, a device that can be clipped onto any prescribed inhaler to treat asthma or COPD.
And in 2015, Teva acquired Gecko Health Innovations Inc. to obtain its CareTRx technology, a device that, like Adherium’s Smartinhaler, can attach to metered-dose inhalers and link to a program which stores data through an application.
The potential of this technology does not stop with respiratory. Novartis is also working with Proteus Digital Health Inc. – a company that aims to merge the digital world with traditional medicine – which has created an ingestible sensor that can be taken with medicine to track adherence and any drug reactions. However, in a possible sign of difficulties to come, its first forays in the regulatory arena were not crowned with success. In May, the FDA turned down a new drug application on a combination product that integrated Otsuka Pharmaceutical Co. Ltd.’s atypical antipsychotic Abilify (aripiprazole) with the Proteus ingestible sensor, intended to improve medication adherence, on the grounds that it needed more information particularly surrounding its usability. (Also see "Digitizing The Pill: Proteus Pioneer Explains How" - Scrip, 14 Dec, 2015.)
Proteus Digital Health’s sensor technology
Digital health apps appear to have potential for improving compliance even in really difficult disease settings. Recently, eHealth company and developer of digital therapies, Pear Therapeutics, presented promising results from a real-life implementation study looking at a research version of its digital application THRIVE in serious mental illness. Used alongside medication, THRIVE provides patients with schizophrenia or bipolar disorder support and options for disease monitoring. The study looked at 342 patients’ engagement with the digital therapy for 3-6 months after being discharged from hospital and found that more than 70% were successfully able to use the application.
Adherence, of course, overlaps with clinical trials. This is another area where the potential of digital health in collecting the huge amounts of data involved in clinical trials is obvious. Companies want to know whether participants are taking the required doses in a study and what the effects of the treatment being tested are. With new technology, companies are finding that they are able to collect data a lot more quickly and efficiently than before.
In its collaboration with Qualcomm Life, Novartis is using the 2net platform as a basis of its clinical trials. As Mault points out, blood pressure is one parameter that would need testing in a trial of a new heart disease drug. Historically a nurse would have needed to take and record the BP measurement but now using technology in the 2net platform participants can measure their own blood pressure and send the data to a cloud.
As might be expected, the big CROs are also getting in on the digital act. Quintiles IMS Inc.’s head of digital acceleration, John Reites, told Scrip about a software tool called ResearchKit developed by Apple, to which Quintiles contributed later enhancements. This software is designed to create mobile applications that can be used to help clinical researchers to gather data more easily, frequently and accurately. ResearchKit enables the creation of applications that collect information from caregivers, doctors and the patient themselves, which is useful for indications like Parkinson’s and Alzheimer’s disease where caregivers play a large role.
According to Otsuka’s executive vice president and chief strategic officer, Robert McQuade, there is real potential to use sensors in clinical trials. Indeed, its partner Proteus Digital Health is in talks with a company for this.
Furthermore, in 2015 GlaxoSmithKline PLC entered into a partnership with Propeller Health in which Propeller was to develop a custom sensor for GSK’s Ellipta inhaler to be used in clinical trials. According to a spokesperson from GSK, the company is looking to use sensor technology in its respiratory clinical studies “to more precisely correlate adherence with safety, efficacy and economic outcomes.” It is still early days for the collaboration, says the spokesperson, but “initial progress is encouraging,” with sensor technology itself being something the company aims to incorporate into its R&D, particularly through partnerships.
GSK’s forays into digital health do not stop at the drug level. The company's head of global multi-channel marketing platform,AJ Ploszay, shed light on how the company was tying its new policy of not paying HCPs for promotionally speaking for the company to its digital transformations, hoping to build “trust fundamentally with the HCP." The company has rolled out various digital features such as web portals, webinars and webcasts to provide physicians and HCPs with more direct, accessible and accurate information. On the patient side, GSK has developed an app called MyAsthma that provides information, support and services to those suffering from asthma to help them manage their condition.
GSK has also incorporated digital applications into its clinical studies and recently announced that it used Apple’s ResearchKit to build an iPhone app to use in its Patient Rheumatoid Arthritis Data from the Real World (PARADE) study. The app GSK PARADE, which is powered by Medidata, a provider of cloud-based solutions for clinical research, and POSSIBLE Mobile, a mobile development agency, will be used to carry out surveys and with the work of sensors, track and collect symptoms of Rheumatoid Arthritis. Through this, GSK is looking to collect and examine data to help shape studies which will ultimately aid in the development of medicines.
But great advances are always accompanied by challenges and questions surrounding data privacy and patient confidentiality were recurring themes for all the companies.
Reams and reams of data are being generated by these new technologies, creating the potential for security lapses and a need to reassure patients that their data are safe. As the pharma industry is already subject to data privacy regulations, patients’ perceptions could be the weak link here, experts believe.
As Landucci said, “Regulations may be a challenge but it's not a hurdle that we cannot overcome.” The challenge, as she sees it, is to change patient behavior and mindsets.
In an survey of the general public carried out by Scrip, two of the major concerns of respondents were safety and privacy, suggesting a hesitancy to put personal health information out in to the virtual space.
Quintiles IMS’ Reites noted, “People are concerned about their security, privacy and what they’re giving up. The only way we can change this is by a very open opt-in consent.” For clinical trials in particular, patients need to know what data they are giving up, what data will be collected, and why, and how long it’s going to be stored.
AstraZeneca’s Bonam agreed: "There are issues which need to be carefully addressed. Issues such as data privacy and security, along with the use of the data for further research, all need to be managed well by the providers and consumers alike. It is also critical that providers deliver digital health tools with the same level of rigor in design, development and evaluation that would be expected of any healthcare intervention."
Qualcomm Life’s Mault, however, took a more robust view, pointing out that the benefits outweigh the risks and the public will just have to get used to a new reality. "This digital evolution is bringing a whole different model of care that everyone will need to adapt to although there will be bumps and frustration.”
He continued: “When you start talking about whether you want your health information digital or somewhere on a piece of paper … it's an unfortunate level of concern right now, because it's not rational when you look at the facts. This digitization has to happen, the healthcare system is so broken and dysfunctional it’s a scary notion for it to not change – the problem is; it's just not changing fast enough.”
When you get a prescription filled, there is a record with your name on it and the medication you are taking, he argued. “All that stuff is on a database, in lots of different places – so you're already facing it, whether you know it or not. You have already been exposed for a long time to the risk of someone hacking into your information – you're already exposed to risks that exist. The problem is you're not getting any of the benefits – the benefits that could save your life.”
Looking To The Future
It is the prospect of the huge benefits that will keep pharma on its digital adventure. Pharma companies are only just starting to get a handle on all that is possible with the advancement of digital technology. Whether it is creating sensors, partnering with companies to build those sensors, designing applications for patients to manage diseases or providing digital channels for HCPs to acquire more information, we are only at the beginning.
So what’s next? Quintiles’ Reites believes that virtual reality could come to the fore in providing education and training in a more engaging way, particularly when commercializing new products. “So much of what we spend our time doing is educating.”
Those doing well in digital health so far, he says, are those being meticulous about the "crawl, walk, run" strategy and spending their time perfecting the crawl. To succeed, pharma needs to keep asking: What value can digital health give us? How does it help patients today? How can we ease into that future as opposed to flat out running from the start?
People won’t be abandoning their smart tech devices anytime soon, and it would make no sense for pharma to not take advantage of it. The day of the biosensor in your body is coming.