Pharma news in clinical trials, chronic condition management, and innovation from Q4 2017

By Jonah Comstock
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Digital health in pharma definitely had a milestone moment in the fourth quarter with the FDA approval of Abilify MyCite, a new, sensor-enabled version of Otsuka’s drug for schizophrenia powered by Proteus Digital Health’s ingestible sensor technology. In addition to that, the quarter saw numerous other moves by pharma companies around clinical trials, chronic disease management, mental health, and, more generally, innovation.

Read on for our fourth quarter pharma round up, then check out Q1, Q2, and Q3 to review the rest of the year.

Mental health

As we wrote in our deep dive on the news, Otsuka’s clearance is the first time a sensor/drug combination has been approved as a pharmaceutical, and it will allow the system to be prescribed like any other drug. If Abilify MyCite is eventually labeled to improve medication adherence, it will represent a big leap forward in adherence monitoring,

That was not Otsuka’s only digital move around Abilify. The startup also partnered with Australian digital health company Medibio to use Medibio’s system to assess the drug’s efficacy. Medibio uses wearable-derived data about heart rate, motion, and sleep to create objective biomarkers for mental illness.

Another pharma company, Takeda, also began studying a digital health intervention for a mental health condition, namely major depressive disorder (MDD). Takeda, Lundbeck US, and Advocate Health Carewill began a study to explore the effectiveness of a mobile app designed to improve engagement between patients with MDD and their providers. The investigation will use the Advocate Pathway App to capture the start of or any adjustments to a patient’s antidepressant therapy. Through a consumer-friendly interface, users will also be able to record their mood symptoms, side effects, medication adherence, and more. These all can be shared with the patient’s provider to guide care and initiate conversations between the two parties.

Chronic condition management apps

A number of pharma companies debuted or worked on developing digital interventions for chronic condition management.

Pfizer was particularly active in this area, coming out with apps for cancer and hemophilia, as well as sharing some learnings from its smoking cessation app, Quitter’s Circle. The cancer management app, LivingWith, includes social components to build a network of loved ones to update about treatments and progression, a dashboard to manage daily tasks and coordinate assistance from family and friends, and features to take notes and keep track of documents between doctor visits. It also includes tracking tools for mood, pain, steps, and sleep.

Pfizer teamed up with the Friends of Haemophilia Society to launch an app game specifically designed to help boys aged four years and older learn about and manage their hemophilia. 

Released in Qatar, “HemoHeroes” tasks players with guiding their ‘hero’ through different everyday scenarios, such as exercising, cooking, and bathing. While each of these are designed to be a fun challenge, they also focus on the lifestyle considerations that come with hemophilia, specifically in regard to healthy eating, oral hygiene, household hazards, taking prophylactic medication, and other areas of disease management.

Additionally, Sun Pharma, makers of severe acne medication Absorica (isotretinoin), released a companion mobile app to help dermatological patients manage their treatment and assist with medication adherence. In addition, the app’s “My Progress Tracker” feature uses the phone’s camera to regularly photograph the users skin at various points in their therapy. By doing so, the app allows users to gauge their skin’s reaction to the medication over time.

In the diabetes space, Eli Lilly and Company announced this quarter that the first Type 1 diabetes patient has been dosed in a feasibility study of the company’s investigational Automated Insulin Delivery system, while Onduo, a joint venture of Verily and Sanofi, announced a slew of new digital health integrations.

Clinical trials

Other pharma companies were involved in clinical trials during the quarter, both testing digital health interventions and using digital technology in drug trials.

An example of the first is Purdue Pharma, which is working with Geisinger Health System on an upcoming trial of medical wearables as an alternative therapy for chronic pain. The ResearchKit study looks to see how wearables (in this case, the Apple Watch) can alleviate pain without relying on pharmaceutical painkillers, a commendable goal for a company whose painkilling opioid OxyContin has been at the heart of the US’ ongoing opioid epidemic.

As for pharmas using digital technology in drug trials, the quarter saw Los Angeles-based Science 37 complete a clinical study for AOBiome Therapeutics conducted entirely through a smartphone app.

The Phase 2b study ran on the back of Science 37’s mobile Network Oriented Research Assistant (NORA) platform, which allows for real-time video chat, customized self-photography models, data collection, and electronic consent. Science 37 says this study marks the first time an interventional, randomized, placebo-controlled trial of this kind has been conducted completely in the virtual space.

Otsuka also deepened its relationship with Science 37.

Another example is Janssen Research and Development, a Johnson & Johnson subsidiary. Janssen announced plans to launch the first clinical trial to use its iSTEP technology toolset, which employs smart blisterpacks and a patient-facing smartphone app, by the end of the year. iSTEP, which stands for Integrated Smart Trial and Engagement Platform, has been under development at Janssen for five years.

Innovation and startups

Finally, pharmas continued to bolster their innovation portfolios by launching accelerators and contests and working with startups.

Health 2.0 saw a number of pharma execs talking about their companies’ approaches to innovation. Executives from BTG, Amgen, and Boehringer Ingelheim talked about their thoughts on build vs buy and spoke about the biggest opportunities in the space right now, particularly around clinical trial recruitment and value-based care.

Bayer also announced at Health 2.0 that it would be bringing its Grants4Apps program, which has been running in Berlin for five years, to the United States. Bayer is hoping to leverage the innovation model that’s been working in Berlin to spur innovation in this self care sector. Specifically, the company is looking at the areas of nutrition, pain management, skin protection, and holistic ecosystem plays.

Self-care and skin protection are also the focus of the The Digital Beauty QuickFire Challenge, launched this quarter by Johnson & Johnson Innovation’s JLABS incubator. Along with funding to advance a product prototype toward commercialization, the challenge’s winners will receive up to one year of residence at the incubator and one funded, custom-designed consumer research initiative at Johnson & Johnson’s Consumer Experience Center.

The challenge is focused on developing three areas of digital skin care: tools focused on educating consumers and improving their self-care, monitoring devices and adherence solutions, and other technology or devices that increase the efficacy of topical therapy applications.