In-depth: Pharma’s digital health initiatives move into commercialization

By MHN Staff
Share

More and more, pharma companies are making real bets in digital health, and reorganizing their businesses to put some power behind those efforts. The space is, in some ways, quieter than it was this time last year, but there’s reason to believe that quiet is a calm before a storm of activity, driven more by pharma’s tendency to keep early-stage projects close to the chest than by a lack of activity. The executives we spoke to for this report talked about initiatives with real potential for broad commercialization.

[To download an eBook version of this in-depth report, visit our sponsor BIO's website right here >>]
 
Boehringer Ingelheim Director of Business Innovation in Digital Health Larry Brooks told MobiHealthNews that advances in its collaboration with Propeller Health demonstrate its progress in the past year. Brooks said this year the focus is more on commercial advancements and less on conducting additional pilots.
 
Meanwhile, GlaxoSmithKline just recently formalized its innovation group, giving it a dedicated team and budget, according to Rob DiCicco, vice president of clinical innovation and digital platform performance at GSK.
 
“The impetus [for formalizing GSK’s innovation group] was that we had maxed out what we could do by asking people to try to do what we’re doing now on top of their day job,” DiCicco told MobiHealthNews. “Because the day job always wins out. … If this is some kind of exploratory project but then you have your day job tied to your performance markers and those sorts of things, the day job always wins out. But by giving it some dedicated budget, it takes one of the barriers away to move these things forward.”
 
The watchword for pharma in 2016 seems to be “partnerships”. Companies are taking notice of the many tech companies and startups offering digital health solutions and are figuring out how to really work with them to improve their businesses and better serve patients.
 
“The first thing we look at is ‘What are we trying to bring to market?’” Ruchin Kansal, executive director and head of business innovation at Boehringer Ingelheim, told MobiHealthNews. “And once we have an understanding [of] what that is, when we say ‘Ok, which of the partners can help us achieve that solution?’ Then we look at how mature the technology is, how good is it, and make the decision based on things like that. The salient point is, what are we going to bring to market and which partners will help us get there?”
 
Some of the biggest pharma digital health stories of the past year have involved partnerships: Daichii-Sankyo tapping Partners Healthcare for their beyond-the-pill solution; GSK, Aptar, and Boehringer Ingelheim all working with Propeller Health on connected inhalers; GSK and Purdue working on Apple ResearchKit pilots; and Otsuka digging deeper into its partnership with Proteus Digital Health to release the first bundled pharmaceutical with an ingestible sensor.
 
Pharma companies are increasingly recognizing the benefits of, working with a partner that’s already largely refined and validated a technology or intervention. DiCicco told MobiHealthNews that GSK’s forthcoming ResearchKit app learned plenty of lessons from early movers in the academic realm.
 
“People in the academic space are a little ahead of pharma in figuring out how to do that, and I think we’re learning from them,” he said. “Groups like MIT [and] University of Rochester have figured out how to quickly put these things in motion.”
 
That’s not to say that partnerships are necessarily the endgame for pharma. Brooks told MobiHealthNews that as pharma moves from pilots into full-scale commercializations of new technology, they may start to develop more solutions in-house.
 
“Our approach has been to work with external companies,” he said. “I think the main opportunity is to figure out what kind of capabilities do we need if we’re going to transform from a pharma company to a healthcare company. We’re going to leverage our existing capabilities, but we’re going to need to create new ones. Once pilots are at commercial scale, we can see broader investments in capability building.”
 
And, of course, M&A is another option for bolting on capabilities to a company, and we’ve seen the beginnings of that trend in pharma as well, with two acquisitions in the connected inhaler space: Teva Pharmaceuticals acquired technology company Gecko Labs last year and Opko Health acquired Inspiro Medical in 2014.
 
It’s still early enough that various pharma companies we spoke to articulated different approaches to innovation. Leo Pharma, for instance, a Danish for-profit foundation, has three innovation labs in different countries that have no defined revenue targets. Instead, they use their budget to cast a wide net and build solutions around one particular condition: psoriasis.
 
“It’s not like we will build all of our solutions,” Miron Derchansky, head of innovation at Leo Innovation Lab in Canada, told MobiHealthNews. “For some of them we’ll hire app developers and engineers, others we’ll find vendors, and for others we’ll do a hackathon. It’s not just about decision solutions, but it’s also the process where we’re trying to shake things up and do things differently as opposed to the traditional corporate approach, where it’s ‘let’s hire 100 consultants to come in and run an innovation session and prioritize their ideas internally’. I’m also meeting with patient groups, and the idea is I’ll send them the top 30 ideas that we’ve had and they vote on their top ideas and then we actually go and build it.”
 
At the Life Sciences Roundtable, co-located at the HIMSS Connected Health Conference last November, Dr. Joseph Kvedar, the vice president of connected health at Partners HealthCare, told MobiHealthNews that he sees pharma companies slowly turning their ships to align with the new realities created by digital technology.
 
"I make analogies to ... healthcare providers who have done quite well under the current system for so long, it’s hard to change," Kvedar said at the time. "Even though we have done well as providers, the amount of margin that pharma companies made in the old way of doing business is breathtaking, so you can imagine it’s hard for them to change. We’re seeing some evidence that it’s being taken seriously now. It is more than just, 'Let’s see if we can add the marketing component by maybe putting an app up that somehow advertises our drug,' but we’ve got a ways to go.”
 
Digital therapeutics
 
One area a number of pharma companies are looking into right now is “around the pill” digital offerings, that could be prescribed by a doctor or bundled with a drug. For instance, Partners teamed up with Daichii-Sankyo to develop a "mobile wrap-around" for a Daichii Sankyo anticoagulate drug prescribed for atrial fibrillation, that will also work with other afib drugs. It will involve a wearable monitoring device and an app, through which patients can receive positive feedback from their doctors and from the automated, personalized feedback generated by the app itself.
 
"We are seeing more of that now,” Kvedar said last year. “We are seeing more instances where people either are adding a wearable component as part of the package or an app that is an integral part of the therapeutic. We have quite a bit of evidence from our own group that tools like apps and wearables in themselves can offer a therapeutic success independent of molecules. We all ought to start thinking quite differently about the space, and not everything that makes you better is a pill.”
 
These sorts of offerings can begin to recognize that the patient experience is bigger than just symptoms and treatments. At Leo Pharma’s Canadian innovation lab, for instance, Derchansky’s team is focused on learning what patient pain points are ignored by a treatment approach that just focuses on medications.
 
“[We explore] any kind of thing that affects the patients living with a chronic skin condition like psoriasis and look at some of the challenges outside of treatment. Between stress management and diet and nutrition and intimacy, there’s a lot of mental, psychological challenges,” he said. “… We identify the need and then we use whatever technology we need to kind of make that happen, whether that’s building apps, web platforms, or augmented virtual reality, artificial intelligence, any tools we need to kind of make the magic happen. … So just last month we had ‘intimacy and psoriasis’. We had a full week where we brought in patients. We brought in psychologists. We talked about some of the challenges and then we started thinking of solutions.”
 
But there are still challenges around this kind of approach. GSK’s DiCicco warned that if apps are going to be prescribed, and considered to be a part of treatment on the same level as a drug, they needed to be validated to the same standard as well.
 
“My children are nine and eleven and they ask for an app every other week,” he said. “And if the app is great and it works they keep playing with it. If it glitches out and they struggle with it, they delete it from their tablet. But if you’ve done a whole development program to demonstrate the value and the benefit to the patient that comes from using the app and the medicine, you have to have a quality program that is very, very different from how we think of the apps we use on our phone today. It has to have almost the same quality element the medicine has in terms of its reliability.”
 
And then there’s an infrastructure problem — for now at least, there are no established pipelines for apps to go through to be vetted on the same level as drugs.
 
“The interesting thing about digital therapeutics or whatever we call them, is that there’s certainly a shorter R&D timeline vs traditional therapeutics, but once you commercialize they don’t really gain the scale that a traditional pharmaceutical would achieve,” Boehringer’s Brooks said. “So it’s kind of got an opposite business model relative to R&D timeline investment and what you get on the backend in commercialization. So I think one of the industry’s opportunities is to figure out how to leverage the ecosystem that’s been built up for pharmaceuticals in order to scale digital therapeutics.”
 
At this year’s HIMSS annual conference, Amanda Havard, Chief Innovation Officer at Health: ELT, made a similar point about health games.
 
“I tend to think that the unknown aspect here is what’s really keeping [health games] from blowing up,” she said. “If you think about what would happen if you had a drug that posted these kinds of numbers, that’s great, but that’s because there’s already a concrete vetting process of how you do a clinical trial, how you evaluate a drug.”
 
Medication adherence
 
Medication adherence continues to be an area of digital health where the field is slowly but surely making progress. It’s a target for the space because it’s win-win — it improves outcomes for patients and revenues for pharma companies. NEHI has long considered it to be a $290 billion problem.
 
“I think we’ve made progress [on adherence],” Boehringer’s Brooks said. “This is in part what the essence of the Propeller collaboration looks to achieve. If we think about it from the perspective of wanting to achieve health — full stop — adherence is and will continue to be a big component of that. Making sure patients take the therapy that’s prescribed is just an important part of achieving adherence to a care plan.”
 
Several times in the past we’ve rounded up the different adherence-focused initiatives in digital health. Some of those, like Johnson & Johnson’s Care4Today mobile app or some of the various smart pill bottle efforts, haven’t surfaced much news recently. AdhereTech launched its version 2.0 bottle in October and is now working with a number of undisclosed pharma companies.
 
Perhaps the biggest recent news in adherence comes from Proteus Digital Health, which has launched two major partnerships for its ingestible sensor system in the last year: a provider partnership with Barton Health in Lake Tahoe, California, and a pharma partnership with Otsuka, which marks the first time a drug will be marketed with a built-in sensor.
 
In a conversation with MobiHealthNews at HIMSS, Proteus CEO Andrew Thompson shared that he sees his company’s commercialization plans and technology as analogous to Tesla’s electric car line.
 
“We are showing the world what drugs with digital drive trains look like, just like Tesla is showing the world what a car with an electric drive train looks like,” he said. “Tesla is going to sell 50,000 cars, but they are probably worth the same as GM … and it is not because they are going to be the biggest car company in the world or because they are going to sell 50,000 cars. It’s because everybody is now betting that when the automotive industry goes electric they will get the technology from Tesla.”
 
Following that analogy, the Proteus’ first commercial pharma deal with Otsuka has similar long term value to Proteus as Tesla’s arrangement with BMW does. Thompson described it a flagship customer that will demonstrate the value of the technology to the entrenched pharma stakeholders.
 
One interesting adherence company we’ve reported on the past is AiCure, which uses artificial intelligence and the phone’s camera to confirm that a patient has taken their pills. AiCure raised $12.25 million in January. Though he didn’t name names, GSK’s DiCicco described a very similar offering to AiCure’s when he spoke about what GSK’s looking at in adherence.
 
“There are some things that are promising in the sensor technology arena, in terms of visual evidence that somebody’s actually done what they’re supposed to do with the medicine,” he said. “There are things like, facial recognition software, to see if people actually swallowed the pill. They’re not perfect but the data looks pretty good. When the app and the visuals tell you the person’s taking the medicine, the blood level also tells you they’ve taken the medicine.”
 
Derchansky, of Leo Pharma, described an interesting adherence project his lab is exploring for topical medications. He noted that adherence to medication regimens for skin conditions is less than 5 percent.
 
“Imagine the iLab creates a little microchip like the tire pressure sensor in your tire,” he said. “A little microchip that goes into your lotion [bottle] and it can tell how much volume is there or how much pressure. Meaning if you haven’t used your medication it sends you a little text that says ‘Hey I’m lonely, squeeze me, this is your medication’ to help with adherence.”
 
But he also made the key point that adherence doesn’t exist in a vacuum, and solutions aimed at patient engagement or education also often improve adherence.
 
“We’re creating an app we’re launching in Canada called In Touch, a teledermatology app [that] focuses on remote follow-ups. So you go to your dermatologist, you get diagnosed with psoriasis or acne or eczema or whatever, you get nonbranded any medication you need and [the doctor says] ‘Please follow up with me a week later.’ You come home, you download the app, you see any photos that were snapped during the visit, and then next week you get a little ping from the app, you do a remote follow-up, take a picture, the doctors can follow-up, so it avoids you coming back into the office physically. In Canada we only have 400 dermatologists, so it’s a huge line, six to 12 months in some areas, so this kind of helps with that.”
 
Though it’s a telemedicine play designed to help combat a specialist shortage, it also has the potential to profoundly affect adherence.
 
“From a business perspective, patients are more engaged, more involved, they have a direct line to their doctor, outcomes are better, but they’re also using their meds in a smarter way and a better way,” he said. “It’s the reason we all brush our teeth the month before we go to the dentist, because we know somebody’s going to be looking at it. Versus ‘Hey, take this lotion, come back in six months’. Those are two different mindsets. So while we didn’t start with ‘Hey let’s think of ways to improve adherence’, we thought about ‘Hey, it’s a pain in the butt to get followups, there’s this auxiliary benefit that spills into the core business.’”
 
At a session at the HIMSS annual conference in February, a team of Indiana University bio-informaticists were also talking about the benefits of a more holistic mindset on adherence. Brian Dixon, a research scientist at Indiana University’s Regenstrief Institute Center for Biomedical Informatics, pointed out that in the area of Type 2 diabetes, digital interventions by themselves still don’t have a great track record.
 
“There have been a lot of efforts in the past to deal with the problem of appropriate medication utilization in Type 2 diabetes,” Dixon said. “Many prior mHealth innovations have offered narrowly scoped solutions with very little success. If you review medication adherence data in diabetes, what you learn is the very best of the studies you see maybe improve medication utilization by about 20 percent. So they’re not really robust, successful interventions.”
 
Going forward, whatever adherence plays pharma makes — and the overwhelming interest in the smart inhaler space suggests it will continue to be a key focus area — they would do well to consider the whole patient experience.
 
Clinical trials

Like adherence, clinical trials are an area where pharma has talked the talk for a long time, but now we’re starting to see them walking the walk. Some of the impetus for that has come from an unlikely source: Apple.
 
DiCicco told us that GSK is pursuing a ResearchKit trial for patients with rheumatoid arthritis. They hope to have the trial launched in the next six months. Purdue Pharmaceuticals is also reportedly working on a ResearchKit trial. Larry Brooks from BI didn’t specify whether his company is, but he couldn’t deny the effect Apple has had on the growing acceptance of remote clinical trials.
 
“We’ve identified opportunities in clinical trials,” he said. “I can tell you from my perspective as a business person that it’s something that will gain greater adoption from the perspective of Apple being a big player. If we’re going to see consolidation, and after that adoption, I think Apple has a key role to play here. My guess is we’ll see further adoptions [of ResearchKit].”
 
Prior to now, the definitive remote clinical trial was a famous trial launched by Pfizer, which the company admitted wasn’t entirely a success. But though the trial was cancelled because of recruitment problems, Craig Lipset, Pfizer's Head of Clinical Innovation, said at a conference last summer that it was a learning experience, as it was meant to be.
 
“For us, we took away a series of modules that worked and one that didn’t," he said at the time. "That’s not meant to imply that online medication recruitment is a failure. In this particular protocol going after that particular patient population, it did fail for us, but the other components did work. So our priority has been to take those components that did work, whether it’s electronic consent or other components, and scale those up. Because we’ve got 200-some clinical trials ongoing every day of the week, so how can we leverage what did work?”
 
And that Pfizer trial was a learning experience not just for Pfizer, but for everyone.
 
"What didn’t work, we’ve socialized, we’ve published, we’ve shared in another form," Lipset said. "We shared it not just out of altruism. We shared it because, if it’s just a Pfizer thing, we’re not going to have support from regulators and other providers. We needed it to be more widely adopted. And I’ve been encouraged that there now have been at least three other pharma companies that have picked up where we left the ball on the field and have taken that farther down. And I’m optimistic that they’ll continue to share so that … it becomes more than just clever little pilots and much more of a mainstream tool.”
 
DiCicco from GSK also cited the Pfizer trial as an important stepping stone to the work being done with remote clinical trials now, and an example of how different pharma companies need to work together in this area.
 
“That Pfizer study that was done a few years ago was very foundational,” he said. “We learned a lot from it. A lot of different companies are tackling individual barrier, and that goes back to my idea of collaboration. We will get there faster if we collaborate on things like that. I think in the end, the ability to put sensors into trials and do telemedicine and point of care and get the data off, that will be a commodity. Everybody will figure out how to do that. It’s what you do with the information, what did you learn from it about your medicine?”
 
That collaboration is also happening via the Clinical Trials Transformation Initiative, a group of pharma companies, academics, and regulators, including FDA, looking to create a new “gold standard” of clinical trial design using digital technology. DiCicco and Brooks both stressed the importance of pharma, providers, and even payers working together on trials.
 
“I think all the stakeholders need to think about this in a different way,” DiCicco said. “Healthcare providers, regulatory agencies, pharmaceutical and biotech need to think about clinical care and clinical research as one entity or one dimension, not a separate infrastructure for clinical care and a separate infrastructure for clinical research.”
 
Boehringer Ingelheim, meanwhile is working with Sutter Health, Anthem, and Humana in different partnerships.
 
“I think those are good examples about how we think we can work together with customers in order to co-develop around research, real world evidence, joint types of patient resources and the like,” Brooks said. “I think certainly digital tools and digital health can fit under that umbrella where we’re working with other stakeholders and ecosystems to deliver value at the end of the day to help them achieve health, not just through pharmaceuticals, but helping with broader things like their entire experience and their entire effort in managing their condition.”
 
Pharma continues to move slowly in digital health, but clearly momentum is building.
 
Digital health news roundup from the past 12 months
 
Q2 2015
 
Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch.
 
Biogen did another MS study in collaboration with PatientsLikeMe, using Fitbit devices. It was a non-controlled feasibility study to assess the potential usefulness of wearables in increasing the activity of people with multiple sclerosis, and in tracking their activity outside of a doctor’s office setting.
 
Boehringer Ingelheim Pharmaceuticals, the Connecticut-based US subsidiary of German pharma company Boehringer Ingelheim, announced in May that it's working with Sacramento, California-based health system Sutter Health on a five-year research collaboration that will explore the clinical value of mobile health technology, data analytics, and other digital health tech.
 
The second quarter of 2015 was especially big for Eli Lilly, a major pharma company that's just beginning to dip its toe in digital health. The company made two related moves, both involving drug delivery devices. First it announced the opening of a new drug delivery and innovation center in Kendall Square in Cambridge, Massachusetts. Construction will begin immediately, with the center opening by the end of the year for a planned staff of 30 scientists and engineers.
 
Then it made an undisclosed investment in San Diego, California-based Companion Medical, a stealthy medical device startup developing a Bluetooth-connected insulin pen and connected app. The company is led by a veteran engineer of Dexcom, Medtronic, and Tandem Diabetes Care, and it intends to improve on the insulin pump for people living with type 1 diabetes.
 
Johnson & Johnson company LifeScan quietly launched a clinical trial to determine whether its OneTouch Verio blood glucose meter (or a not-yet-launched version of it) creates a greater reduction in A1C levels when used in conjunction with its companion app.
 
In April, Johnson & Johnson was one of several companies to partner with IBM's new Watson Health unit. The focus of the collaboration was on creating app-based coaching systems using Watson. The initial focus area will be preoperative and postoperative care for joint replacement and spinal surgery. They also plan to launch apps focused on chronic conditions.
 
Then in June, McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that makes over the counter medications like Tylenol and Zyrtec, released a new mobile app, called Healthyday, that uses crowdsourced data to inform users about location-based allergy, cold, and flu trends. The app is the first to make use of an API from Sickweather, a company that has offered its own version of a health map app for years.
 
In April, AstraZeneca followed the lead of Genentech to sign a five-year data access deal with patient community PatientsLikeMe. AstraZeneca will have full access to PatientsLikeMe’s global network, and the company will use the data to shape future medicine development and work to improve outcomes in different therapeutic areas, with an initial focus on respiratory disease, lupus, diabetes and oncology.
 
At the BIO conference in June, Craig Lipset, Pfizer’s Head of Clinical Innovation, shared some information about the fate of 2011's Remote clinical trial, a Pfizer trial that was to have been conducted entirely remotely, but was cancelled because of lack of enrollment. Since 2011, Pfizer has incorporated many successful facets of that trial into its ongoing efforts — and has put the failed aspects out there for other companies to learn from.
 
Pfizer also joined a research initiative, called Project Catalyst, led by AARP. where the organization will work with partners including Pfizer, UnitedHealthcare, and Georgia Tech to promote an increased focus on users over 50 in digital health research and development. The first project of the new initiative, focused on sleep and activity trackers, is launching at Georgia Tech.
 
A few smaller pharma companies also had news this quarter. News emerged that BioDelivery Science, a specialty pharma company based in Raleigh, North Carolina, released an app back in December to help support recovering opioid addicts. The app, called InReach, is designed to work with the company’s drug Bunavail.
 
In June, we learned that a mystery pharma company is working with Scripps Health on a novel clinical trial: one that is actually a behavioral trial, not for patients, but for cardiologists. Its goal is to help Scripps discover what kind of results are necessary to drive adoption of digital health technology among providers.
 
New Jersey's Division of Consumer Affairs launched an app in April for iPhones that will allow authorized users of the state’s prescription monitoring program, prescribers and pharmacists licensed in New Jersey, access to the database via their smartphone. The database is managed by the New Jersey Prescription Management Program (NJPMP), a program under the Division of Consumer Affairs.
 
Walgreens President and Walgreens Boots Alliance EVP Alex Gourlay, who transitioned over from Boots, spoke at HIMSS 2015 about a few digital health-related deals the company made and some of the larger strategy behind them. Gourlay laid out a three-point strategy for Walgreens: becoming patient-led, promoting innovation, and good partnerships.
 
Gamified medication adherence app maker Mango Health moved beyond medications, using a new Google Fit integration to add tracking of blood pressure and weight, as well as activity tracking, into its app, the company announced.
 
In addition, Swedish clinical trial recruitment company Trialbee raised $5 million to support its entrance into the US market and Iodine, the crowdsourced medication review company run by former Wired editor Thomas Goetz and former Google engineer Matt Mohebbi, launched a new study to look specifically at the effects of antidepressants.
 
A report in the second quarter revealed Teva Pharmaceuticals may have made an eight-figure investment in American Well. According to Globes, the investment of "tens of millions of dollars" is part of a new push into digital health by Teva, which has also included the development of a cellular-connected smart inhaler, an app for reporting negative drug interactions, and a "digital support center for multiple sclerosis patients", as well as an incubator launched in Israel in collaboration with Philips.
 
A small study of veterans with epilepsy, conducted by PatientsLikeMe and sponsored by pharmaceutical company UCB, shows that an online patient community can increase self-efficacy and self-management of patients. The study was published in the journal Neurology. A total of 92 patients enrolled in the study and completed a six-month follow up survey.
 
Iodine, the crowdsourced medication review company run by former Wired editor Thomas Goetz and former Google engineer Matt Mohebbi, launched a new study in May to look specifically at the effects of antidepressants.
 
A study published in the BMC Medicine medical journal in May concluded that smartphone apps that offer an insulin dose calculator may actively contribute to incorrect dose recommendations, according to the systematic assessment of 46 insulin dose calculator apps available on iOS and Android in the UK App Store. Apps data was collected in August 2013.
 
Q3 2015
 
There wasn't much pharma news in the beginning of Q3, but as the quarter drew to a close, several announcements started to come out of major pharma companies. This quarter, AstraZeneca was particularly active in the digital health space and a few pharmaceutical companies made accelerator-related announcements.
 
One of the few early pharma announcements came out of Novartis, which released a new Apple Watch and Android Wear app geared at helping visually-impaired people navigate their environment. The app is one of two Via Opta apps that have been available on the iPhone since August 2014, but a new upgrade adds additional features and brings Via Opta Nav onto a wearable for more convenient navigation.
 
A few months later, news broke about both connected contact lenses Google and Novartis are working together on: A new patent application shed light on how Google might power its glucose-sensing contact lens, just a week after Novartis told a Swiss newspaper it was on track for human trials in 2016 of an autofocus lens for presbyopia patients.
 
Roche Pharma Research and Early Development, a division of Roche Pharmaceuticals, developed a mobile app to measure Parkinson’s disease symptoms. The app was developed in partnership with Max Little, a British mathematician at the head of the Parkinson’s Voice Initiative, and it will actually be used in a drug development trial with Prothena Biosciences.
 
Roche subsidiary Roche Pharma France, partnered with French medical app company Voluntis to develop a mobile-based therapy for breast cancer. Voluntis makes companion apps as medical devices. It has so far focused on the areas of diabetes, hemophilia, and coagulation.
 
Roche also launched an FDA-cleared diabetes app with insulin calculator in US. It received FDA clearance for the Android version of the app in mid-March and finally received clearance for the iOS version in early June, using the Android clearance as the predicate device.
 
Indianapolis-based pharma giant Eli Lilly announced that the company started offering an Android version of its app, called Glucagon, which is designed to help caregivers and providers treat people with diabetes if they fall into an insulin coma.
 
Sanofi and the Joslin Diabetes Center partnered with Google Life Sciences, which would later be renamed Verily. At the time, the team explained in a statement that the organizations have partnered "to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management."
 
AstraZeneca partnered with mobile-enabled health coaching services company Vida to launch an app, called Day-by-Day, that helps patients who are recovering from a heart attack. The app is not only designed to speed up the patient’s recovery, but it also helps patients deal with trauma that they may feel after experiencing a heart attack. The app is currently part of a trial program at Duke University.
 
AstraZeneca also partnered with New Zealand-based Adherium Limited, which offers a mobile-enabled inhaler, to incorporate digital health offerings into AstraZeneca’s patient support programs for people with COPD and asthma.
 
Shortly after this announcement was made, Adherium released data from three small studies of the company’s Smartinhaler system. Data from the studies, all of which involved children and adolescents, indicated a 144 percent increase in adherence for patients using the connected devices, a 14.9 percent increase in lung function and a 37 percent reduction in oral steroid usage, as well as qualitative insights about patient reactions to the form factor.
 
And in August, Adherium raised $25.6 million ($35 million AU) in an initial public offering on the Australian Securities Exchange, including a $3 million investment from AstraZeneca.
 
Towards the end of the quarter, AstraZeneca publicly released preclinical data from more than 50 of its medicines in order to find new drug combinations for cancer treatments. The data AstraZeneca released will be used in a competition it created in partnership with the DREAM Challenge, a non-profit, collaborative community that runs crowdsourcing efforts for biology.
 
Finally, Teva Pharmaceuticals announced that it would acquire Cambridge, Massachusetts-based Gecko Health Innovations (previously known as GeckoCap), a smart inhaler company. The terms of the deal were not disclosed.
 
Johnson and Johnson Innovation (JJI) announced that it was teaming up with hardware manufacturing company PCH to create Hardware for Health, an accelerator of sorts for companies with a consumer health oriented hardware prototype.
 
Merck Sharpe and Dohme (MSD), the UK subsidiary of US pharma company Merck and Co, partnered with Wayan Open Future, a digital startup accelerator run by Spanish telecom company Telefonica to create a new digital health accelerator focused on preventative health.
 
Pharma company Bayer HealthCare announced the next five startups that would take part in the company's Grants4Apps accelerator program in Germany.
 
In December 2014 NYC-based tech accelerator Blueprint Health spun off the Blueprint Health Collective, renamed Junto Health, to help stakeholders like payers, pharma companies, and hospital systems, find and curate innovative solutions to their problems by working with the right startups -- or by developing innovations together in-house. This quarter, Junto Health added another dimension to the service by promoting the Sachs Policy Group from a member of the consortium to a partner.
 
After years of using its digital health feedback system in clinical trials and studies, Proteus Digital Health, and partner Otsuka Pharmaceuticals, submitted a sensor-embedded version of the antidepressant Abilify for FDA approval.
 
Meanwhile, Madison, Wisconsin-based Propeller Health secured two FDA clearances for new sensors that are designed to work with two particular inhalers on the market: the Diskus inhaler from GlaxoSmithKline and the Respimat inhaler from Boehringer Ingelheim.
 
Other pharma-related news included a report released by German app company SmartPatient that found 66 percent of all pharma app downloads in the United States, the United Kingdom, and Germany, were downloads of the top 10 apps and an app launch from Iodine, the crowdsourced drug review startup that launched last year. Iodine's new app aims to help users document their experience with antidepressants.
 
And PillPack, the mail-order pharmacy that raised $50 million last June, went mobile this quarter, launching its first app, for iOS and Apple Watch. The PillPack app will be available to everyone, not just PillPack customers, and has several novel features for a medication reminder app.
 
Q4 2015
 
At the Health 2.0 conference in Santa Clara, California, Greg Powell, director of pharmacovigilance at GlaxoSmithKline, spoke about how the pharma company uses the data it collects from its partnership with Epidemico. GlaxoSmithKline collected data about public postings on Twitter and Facebook that mentioned any of a list of 1,000 of the company’s drugs. Altogether, they found more than 6 million hits on Twitter and more than 15 million hits on Facebook.
 
Later that quarter, GlaxoSmithKline and Madison, Wisconsin-based Propeller Health announced a partnership in which Propeller would develop and manufacture a custom sensor for GSK's Ellipta inhaler for COPD patients.
 
At the HIMSS Connected Health Summit in National Harbor, Maryland, Pfizer executives talked about two of the company's apps and their broader strategy for developing mobile health interventions. Pfizer said it has 15 apps in the US iOS app store, ranging from a chapstick companion app to an app for people with kidney cancer.
 
French companion app company Voluntis partnered with AstraZeneca to develop an app for women undergoing treatment for ovarian cancer. Specifically, the app will help patients and clinicians manage the side effects of a combination therapy of the drugs cediranib and olaparib, which can cause hypertension and diarrhea.
 
San Diego, California-based PatientSafe Solutions acquired all the assets of Merck subsidiary Vree Health for an undisclosed amount. The acquisition would help the care coordination and provider workflow company expand its offerings to the home care market in addition to the hospital. The acquisition may have had something to do with the fact that Merck Global Health Investment Fund (Merck GHI) is already a major investor in PatientSafe.
 
Google Life Sciences finally got its new name as an independent company under the aegis of Alphabet: Verily. With the launch of a new website, the company has also clarified and cemented its mission: to bring different healthcare and technology stakeholders together to reinvent areas of healthcare.           
 
Foster City-based Oration, which is backed by Google, launched a mobile offering that helps employees save money on prescriptions.
 
The FDA wants to know more about mobile-enabled clinical trials for investigational drugs. According to a post on the Federal Register by Associate Commissioner for Policy Leslie Kux, the FDA is soliciting comments "from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations".
 
CVS Health announced the launch of five new digital offerings that help customers refill prescriptions and manage their medications. The digital tools include an Apple Watch app, a prescription scanning feature, an insurance card scanning feature, a medication reminder called MedRemind, and in-store messages.
 
San Jose, California-based Akibah launched a crowdfunding campaign for its connected glucometer smartphone case, called GluCase. The company's CEO is Larry Ellingson, who was previously chair of the American Diabetes Association as well as executive director of diabetes care at pharma company Eli Lilly.
 
AdhereTech, the New York City-based smart pill bottle company, began shipping the generation 2 version of its bottle to pharma and provider customers. The new version incorporates a number of changes based on user feedback that make it more robust, easier to use, and expand the reach of the company outside the United States.
 
Mail-order personal genetics service and research company 23andMe completed a $115 million round led by Fidelity Management and Research Company with participation from  Casdin Capital, WuXi Healthcare Ventures, and Xfund, as well as existing investors Illumina, New Enterprise Associates, MPM Capital, and Google Ventures.
 
Austin, Texas-based RxWiki, which offers a medication encyclopedia written and edited by pharmacists as well as tools to help community pharmacists to communicate with consumers, raised $5.7 million.
 
Los Angeles-based mobile clinical trials company Science 37 raised $6.5 million from Lux Capital and dRx Capital, a joint venture of Qualcomm and Novartis that launched in January.
 
San Francisco-based TinyRx, a prescription delivery service, launched with $5 million in funding from Eight Partners, Google Ventures, Stanford’s StartX, as well as angel investors.
 
Q1 2016
 
Novartis announced a partnership with Qualcomm Life, a subsidiary of Qualcomm, to develop a connected version of its inhaler, Breezhaler, for people who have COPD. Specifically, Qualcomm Life will develop the reference design for the module that will connect the Breezhaler to the Qualcomm Life 2net platform, a hub for connecting home health devices. This platform will collect data on inhaler usage, including the duration of the patient's inhalation, which Novartis said indicates quality of the inhalation.
 
A month later, Novartis signed deals with two major health plans, Cigna and Aetna, to reimburse for its new heart failure drug Entresto. The deals are among the first publicly announced examples of outcomes-based drug pricing. While Novartis discussed using digital health devices as part of its planned Entresto rollout last year, reports about the new payer deals have not mentioned the prospect of including digital health tools in the mix.
 
And a week later, Microsoft announced a partnership Novartis that began a few years ago to create a system, called Assess MS, that better evaluates how patients perform on multiple sclerosis (MS) tests. The current MS tests require patients to perform movements, like touching their nose or sitting with their arms outstretched. Providers watch the patients and rate their movements on a scale, but ratings that providers give are somewhat subjective, according to the companies.
 
Another pharma company, GlaxoSmithKline, also partnered with Qualcomm. According to a report in Bloomberg, GlaxoSmithKline is in talks with Qualcomm to create a new joint venture to develop medical technology. Financial Times added in its report that the JV could be worth up to $1 billion.
 
Digital smoking cessation company 2Morrow partnered with GlaxoSmithKline to offer the company’s Nicoderm CQ Patch to smokers who complete 2morrow’s cessation program.
 
Propeller Health and Boehringer Ingelheim announced a commercial partnership. Under the partnership, COPD and asthma patients using Boehringer's Respimat inhaler will have the opportunity to enroll in a program at select health systems that will monitor their adherence via a Propeller sensor and improve their engagement in their health.
 
Nestle is conducting a two-year clinical study with data company Medidata in China to assess the impact of physical activity and nutrition on adults with joint discomfort. The study will use Garmin fitness trackers and a mobile app.
 
Propeller Health announced a partnership with Aptar Pharma, a drug delivery system company, to create what the company believes will be the first-to-market integrated, connected metered dose inhaler (MDI).
 
The Medical Research Institute of New Zealand (MRINZ) announced that it plans to launch an multi-country clinical study, called Novel START, using New Zealand-based Adherium’s connected inhalers. In addition to New Zealand, other study sites will be in Australia, the United Kingdom, and Italy.
 
AiCure, announced that it had raised $12.25 million in a round led by New Leaf Venture Partners, with additional funding from Pritzker Group Venture Capital, Tribeca Venture Partners, and Biomatics Capital, established by Boris Nikolic, former Chief Advisor for Science and Technology to Bill Gates. The company has developed a smartphone camera-powered medication adherence tracking offering.
 
Baltimore, Maryland-based WellDoc announced a collaboration with LifeScan, a Johnson and Johnson company that makes blood glucose meters. WellDoc also raised an additional $7.5 million from Johnson & Johnson Innovation and other investors, bringing the company’s total funding in its most recent round to $29.5 million.
 
And Greyhealth group (ghg), a healthcare-focused agency owned by WPP that was a founding partner of Text4Baby and an early IBM Watson partner, acquired The Lathe, a health app design and development firm, for an undisclosed amount.
 
Recently, Quintiles, a company that helps pharmaceutical companies improve clinical trials, named Dave Tripi as its vice president of global operations. Tripi has worked at various Johnson & Johnson subsidiaries for at least 20 years. He most recently worked for Janssen Healthcare Innovation.