Digital therapeutics, medication adherence, clinical trials were key pharma interests in Q2

By Jonah Comstock

Pharma companies are getting more and more open about their digital health initiatives, which has given more opportunities this quarter than usual to chronicle pharma’s efforts around adherence, clinical trials, and the burgeoning world of digital therapeutics. In addition, at the BIO conference in Boston this quarter heard pharma innovation leaders share their stories.

How big pharma is tackling innovation today

Pharma’s interest in innovation was displayed at BIO where a lot of enthusiastic conversations about digital therapeutics took place. 

During an afternoon roundtable session held Wednesday at BIO 2018 in Boston, a panel of digital medicine and pharmaceutical representatives discussed the impact that these novel medicines have had, and could have, on drugmakers, regulators, and those prescribing the medications.

While it’s easy to point to regulatory forces as a potential impediment to digital adoption, members of the panel were generally warm to the FDA’s ongoing work to classify the new treatments. Otsuka Phamaceuticals' Senior Director of Global Clinical Development Timothy Peters-Strickland in particular was full of praise for the agency that was “finding a path” during its hands-on appraisal of Abilify MyCite.

“Since our approval and even before our approval, the landscape is starting to change,” he said. “We’ve had, I think, around 15 interactions with the FDA just around this product … and we’ve had more FDA meetings face-to-face than we’ve ever had before with any of our other products. They’ve been engaged, I think they wanted a path forward as much as we did.”

Novartis is also keen on digital therapeutics, as their VP articulated at another session at BIO.

“If you think about the trajectory of medicine what is a drug these days: is it a pill, is it an injection, is it infusion, is it gene therapy? We’ve created some artificial constructs in the industry,” Jeremy Sohn, vice president and global head of digital business development and licensing at Novartis, said. “The thing that is always constant, as the FDA will tell us, is it is about data-driven processes that allow us to demonstrate efficacy and truth.”

In the run-up to BIO, Sanofi VP of Digital Business Development and Licensing Rachel Sha spoke to about Sanofi’s innovation strategy. The company applies digital and innovative solution across all appropriate areas of the business. But in each of those areas, it’s focused on two strategic priorities: drug discovery and development and what Sha calls “drugs ”, ways in which hardware and software can be bundled with drugs and improve outcomes. And in all areas the company relies on partnerships, especially with startups and larger tech companies, to bring those innovations to Sanofi.

Pfizer also turns to startups to spur innovation, in the form of its Pfizer Healthcare Hub: London competitive grant. This was the second time that Pfizer has held the startup-focused program, which representatives from biopharmaceutical company said had a strong inaugural year in 2017.

Medopad, an app platform for patients to log and share data during clinical trials or care; Inhealthcare, a remote patient monitoring company; and Perfect Ward, an app-based tool that helps conduct and report healthcare inspecting results, were chosen as recipients of the grant. Each will receive a share of the roughly $70,000 (£50,000) grant alongside a year of support and access to Pfizer’s regional partners, which includes the National Health Service.

Pharma turns to digital to bolster adherence

The use of digital technologies to improve medication adherence has moved beyond tests and pilots.

This quarter saw the FDA grant over-the-counter clearance for AstraZeneca’s SmartTouch for Symbicort connected inhaler. The device grafts onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is designed to be easy to install and remove, and includes three buttons that help patients access the audio visual-reminders, battery monitoring, and Bluetooth low-energy pairing features. OTC clearance will allow the inhalers to get into the hands of more Symbicort users.

Boehringer Ingelheim partnered with at least two digital health companies this quarter to improve medication adherence.

Early in the quarter, following a successful nine-month pilot, Boehringer and HealthPrize Technologies announced that the digital adherence support program RespiPoints will be expanded to any patient who is taking certain Boehringer Ingelheim medications, including some available in the Respimat inhaler. Launched in 2016, the web- and mobile-based RespiPoints program offers patients a variety of adherence-building activities and challenges that reward points redeemable for electronic gift cards.

Later in the quarter, Boehringer announced a partnership with Medisafe, again following a successful pilot. The partnership is around the oral anticoagulant Pradaxa. Medisafe will offer a wraparound app experience that incorporates Pradaxa-specific educational information into a special version of its app, which patients will be directed to when they're prescribed the drug. Pradaxa patients will have access to all the normal Medisafe features, including adherence tracking, alerts, biometric tracking, and MedFriend, a service that notifies friends and family when the user is nonadherent. Prescribing physicians will have access to Medisafe's physician portal, which allows them to see the patients' adherence information.

Although some pilots in this space are coming to fruition, others are just beginning. Novo Nordisk and San Francisco-based Sempre Health announced their collaboration in April on a pilot program that will offer diabetes medications through Sempre’s monetary incentive and SMS-driven prescription refill platform. The partnership is hoping to engage 10,000 diabetes patients on Sempre’s platform within 2018.

Companion apps take aim at particular conditions

Biogen launched a new app this quarter, though it doesn’t wrap around a particular drug. Called Aby, it’s aimed at giving people living with multiple sclerosis (MS) support, as well as accurate and reliable information about the condition. The app is free and gives users articles, tips and inspirations about living with the condition. It also provides patients a personal journal, where they can create custom treatment reminders, track appointments, and record symptoms, mood and physical activity. App users can also access exercise videos that were developed by healthcare specialists in the MS community that are designed specifically for people living with MS. 

At the Healthcare Experience Design (HXD) conference in Boston, Dr. Kamal Jethwani, senior director of connected health innovation at Partners Healthcare, shared another case study of an app for a particular condition: They partnered with UCB to develop an app for epilepsy patients. The team came up with a simple platform doctors and patients can look at together that they call RefleX. The platform gives facts about medication price, insurance coverage, and side effects. Jethwani detailed how Partners and UCB worked with a patient advisory panel to create the intervention.

Clinical trials still an area of interest

Remote clinical trials have long been a major focus of pharma’s digital health efforts. These days, pharma companies are also increasingly eyeing artificial intelligence as another clinical trial game changer.

At the World Medical Innovation Forum in Boston on April 24, a panel of pharma leaders discussed the future of AI in the industry

“It's quite top of mind for us at Novartis as we are reimagining life science companies like ours as medicines companies powered by data and digital and also because the radical advances, perhaps driven by consumer applications of this critical vector of computer science, have overt, immediate, and profound downstream relevance,” Dr. Jay Bradner, president of Novartis Institutes for Biomedical Research, said at the event. 

Also present at the event was Roche, which recently acquired oncology tech company Flatiron Health. In May, Flatiron and Bristol-Myers Squibb announced a three-year collaboration that will allow the biopharmaceutical company to use Flatiron’s data for research and development. The effort will focus on generating real-world data across a range of tumors and broadens access to Flatiron and Foundation Medicine’s Clinico-Genomic Database.

While AI may be the future of clinical trials, mobile apps and wearables are rapidly becoming the present.

For instance, ActiGraph activity monitors and a mobile app from Clinical Ink were at the heart of a pilot study backed by Bayer and announced this quarter. The ongoing study is evaluating how these digital products and a Bluetooth-enabled weight scale are perceived by patients, and the feasibility of implementing such devices in future clinical trials run by the pharmaceutical company.

Novartis, meanwhile, launched an app specifically designed for eye patients to participate in ophthalmic clinical trials. Built with ResearchKit, the FocalView app looks to improve data captured by allowing patients interested in participating to conveniently self-report their conditions through their smartphone, thereby providing researchers with a greater wealth of time-stamped data.

And Science 37 announced  to implement the former’s site-less clinical trial platform in neurology and immunology research. UCB’s studies using Science37's decentralized Metasite model are slated to begin later this year.

Additionally, CRF Health announced this quarter that its TrialMax Touch and TrialMax Slate products will be implemented in a phase 3 clinical trial conducted by an unnamed Japanese pharmaceutical company. The study will enroll 800 screened and 320 randomized subjects across 40 US trial sites. TrialMax Touch will be provided to participants so that they can easily report daily updates using their smartphone, while TrialMax Slate will be provided to the investigators to help them better manage their patients and other study logistics. 

At BIO 2018, Pfizer’s Daniel Karlin led an interesting and wide-ranging discussion about how pharma’s increasing use of wearables and apps is leading to a need for new and better data standards.

“We’re trying to take the real world and encode it in a way that makes sense,” Karlin said during the panel. “And we’ve hit a point in that effort where there’s a recognition … that without some efforts at standardization, and interoperability, and research that’s reproducible from one site to another and one device to another, it’s going to be really, really difficult to have the observations made by digital devices take on real meaning.”