Q4 2016 Pharma Sector Review: Surge in Clinical Data Collection and Chronic Disease Management, Especially in Diabetes

Pharmaceutical news in the fourth quarter of 2016 largely fell into two categories: clinical trial data collection and chronic disease treatment, with the latter placing particular emphasis on diabetes and chronic respiratory diseases. MobiHealthNews compiled news reports from several global pharmaceutical companies during that period, and VCBeat (WeChat ID: vcbeat) translated and edited the content.

We observed that in the fourth quarter, pharmaceutical companies made substantial investments in digital tools designed to enhance data collection in clinical trials.

In early October,Sanofi (Sanofi) injected $31 million into Science37 through its investment arm, Sanofi-Genzyme Ventures. Volunteers willing to participate in medical trials and researchers conducting these trials connect through Science37, enabling volunteers to take part in clinical trials from the comfort of their homes.

“We are pleased to see the expansion of our investments in the digital health sector, with Science37 marking a new starting point for this expanded commitment. Science37 is a leading digital technology company that applies revolutionary digital technologies to the design of clinical trials and participant enrollment,” said Bernard Davititan, General Manager of Sanofi Genzyme BioVentures, in a statement at the time. “This investment aligns perfectly with Sanofi’s digital strategy and provides us with an opportunity to play an active role in the digital revolution.”

Takeda Pharmaceutical has also been highly active in the field of clinical trials. In late October, Litmus Health (a company dedicated to helping pharmaceutical companies improve the efficiency of Phase I and Phase II drug trials through the use of wearable devices)Announces Collaboration with the University of Chicago to Test the Impact of Activity, Sleep, and Diet on Patients with Inflammatory Bowel Disease (IBD). This trial was funded by Takeda Pharmaceutical Company.

Takeda has also adopted the platform of Koneska Health, an early-stage technology company dedicated to collecting data and monitoring health metrics via mobile phones, wearable devices, and other digital technologies, thereby supporting pharmaceutical companies in clinical trials that utilize biosensors and wearables. Takeda aims to develop what it calls “digital biomarkers,” which involve gathering data from devices that continuously monitor patients’ vital signs, activity levels, and sleep metrics. Ultimately, Takeda hopes these data will aid in decision-making and enable a comprehensive assessment of patients’ daily physical conditions.

The company has also partnered with Definiens, a German image analysis and data company, to conduct research on tissue analysis, another area of clinical trials. Definiens’ VeriTrova, a cloud-based digital pathology platform, enables biomarker analysis, allowing Takeda to reduce the standard analysis time from months to weeks.

Two Distinct Business Units of Johnson & Johnson Made Headlines in Q4 Digital Health News. In October, prompted by an alert from the cybersecurity firm Rapid7, Johnson & Johnson issued a warning through its subsidiary Anima to users of the Animas OneTouch Ping insulin pump, notifying them of a security vulnerability and providing instructions on how to mitigate the risk. According to Rapid7’s statement, because communication between the remote control device and the insulin pump is unencrypted, attackers could theoretically manipulate the pump from up to two kilometers away, administering unauthorized insulin doses to patients and thereby posing a risk of potential hypoglycemia.

In December, Johnson & Johnson’s subsidiary LifeScan delivered better news: the U.S. Food and Drug Administration (FDA) approved a wireless integrated device, which represents an integration of LifeScan’s blood glucose monitoring system with WellDoc’s digital management platform for patients with type 2 diabetes.

The two companies initially collaborated in March 2016. The integrated system includes the OneTouch Verio Flex, LifeScan’s Bluetooth-enabled smart blood glucose monitoring system and its companion app, as well as WellDoc’s FDA-cleared mobile diabetes therapeutic platform, BlueStar.

Additionally, this quarter, Common Sensing announced a partnership with the Joslin Diabetes Center and Sanofi (Sanofi) and Dkang Medical (Dexcom) jointly conducted clinical testing on the cap of their developed smart pen-style insulin injector.

A total of 125 patients participated in the trial, which was led by Joslin and funded by Sanofi. Each patient received a Gocap smart cap from Common Sensing, designed for disposable insulin pen injectors. The device detects when the injector is used and measures the amount of insulin remaining. Patients also received continuous glucose monitoring (CGM) devices from Dexcom.

Eli Lilly (Eli Lilly), the company also invested in the pen injector sector in 2015 and developed a mobile application for patients with type 2 diabetes using Trulicity. Trulicity is a once-weekly injectable medication for diabetes produced by the company, which can also be used with the KwikPen. Since September, all features of the app have been fully implemented, and it is currently available free of charge on iOS for individuals with a Trulicity prescription.

The Trulicity app offers several distinct features for patients using this medication: it serves as a virtual demonstration pen, simulating the actual Trulicity pen in terms of every characteristic, function, and measurement; it provides weekly reminders to take medication according to the user’s pre-set schedule; and if users require assistance with administration, it can send timely messages or place calls to the Lilly Answers Center. Ultimately, Senseonics expanded its partnership with Roche in December (Roche) signed exclusive distribution agreement. Senseonics, a company based in Germantown, Maryland, is dedicated to the development of Eversense, a long-term implantable continuous glucose monitor.

Now, Roche (Roche) exclusive rights to promote and sell Eversense products to diabetes clinics and patients in most of Europe (excluding Scandinavia and Finland), the Middle East (excluding Israel), and Africa. This agreement builds upon an agreement signed by the two parties in May, which granted Roche the same privileges in Germany, Italy, and the Netherlands.

Adherium, a company with close ties to AstraZeneca, has been selected for the EU’s myAirCoach project, a multidisciplinary research initiative funded under the European Union’s Horizon 2020 Research and Innovation Framework Programme.

Next year, Smartinhaler will be deployed at Imperial College London, the University of Manchester, and Leiden University Medical Center to assist in patient treatment.

The project was supported by the Greek Research and Technology Centre. A new study conducted at Sheffield Children’s Hospital in the UK at the beginning of this quarter demonstrated that Adherium’s Smartinhaler increased patient medication adherence by 43% and reduced hospitalization rates fivefold. The findings were published in Thorax. The randomized controlled trial included 77 children with asthma.

Similarly, Propeller Health, based in Madison, Wisconsin, offers a digitally guided respiratory therapy platform. In collaboration with multiple pharmaceutical companies and the Medical Institute for Research (MIR), the company provides not only the Propeller System but also mobile and clinical spirometers from Italian health technology firms. Propeller has also secured FDA 510(k) clearance for its latest product, a sensor compatible with GlaxoSmithKline’s Ellipta inhaler. This marks the eighth time the company’s products have received FDA approval, an achievement realized since its partnership with GSK began last December.

At the beginning of this quarter, GlaxoSmithKline partnered with The Weather Channel and the WeatherBug website to launch a cold and flu tracking application, enabling users to monitor the latest local activity levels of colds and influenza.

The application is also part of GSK’s promotional campaign for the launch of Theraflu ExpressMax Caplets, making Theraflu the company’s first brand to leverage IBM Watson for advertising. Consumers can interact with Theraflu advertisements via voice or text through websites or smartphones, asking Watson questions such as, “How long is the flu contagious?” which will be answered by Watson’s chatbot.

When it comes to IBM Watson, Teva Pharmaceuticals has entered into a three-year research collaboration with IBM to integrate its capabilities with the Watson Health Cloud. Building on the existing alliance between the two companies, this project focuses on two critical areas in healthcare: developing a systematic approach to discovering new indications for existing drugs and improving the treatment of chronic diseases. They have also partnered with the pharmaceutical company Celgene to develop monitoring tools for adverse drug reactions. The cloud-based Watson Patient Safety tool is designed as an automated drug safety service that rapidly collects and organizes large volumes of patient data from multiple sources, including electronic health records (EHRs), medical claims databases, and other information channels.

Ultimately, Watson’s patient safety tools will enable pharmaceutical companies to rapidly flag issues when safety concerns arise.

This quarter, StartUp Health, a digital health investor and incubator, signed a three-year partnership agreement with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) to enable Janssen executives to more directly leverage StartUp Health’s network of digital health entrepreneurs and innovators. The FDA stated that it may revisit its social media guidance after collecting risk-benefit data reported via the web, which is not constrained by the character limits imposed by social media platforms.

The agency posted a research proposal for public comment in the Federal Register in November. The proposed research comprises four studies—two conducted on Twitter and two on Google Ads—involving a total of 6,502 participants. The studies will examine consumer behavior when exposed to mock advertisements for a weight-loss drug and for a migraine treatment.