By Jonah Comstock | July 14, 2017
In Q2 2017, we continued to see more pharma companies step up their efforts in digital health, from app launches to FDA clearances to wearable usage in clinical trials. Read on below for a summary of those moves.
In a move that could have growing significance for pharma going forward, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership of pharma companies, academics, and regulators, including FDA, looking to create a new “gold standard” of clinical trial design using digital technology, released new endpoint recommendations focused on the use of mobile technology in clinical trials.
“By engaging with experts who have been early champions of mobile technology in trials and combining that with patient insights, CTTI has created practical recommendations and action-oriented tools that have the potential to really accelerate the use of mobile technology in clinical trials,” Craig Lipset, Pfizer’s head of clinical innovation, said in a statement at the time. “In particular, the use cases provide a realistic pathway for incorporating novel endpoints through technology into clinical development programs. CTTI’s recommendations show we may be closer than previously believed to realizing the benefits of these novel endpoints, creating a sense of urgency to act.”
Along those same lines, life sciences consulting firm Parexel teamed up with Sanofi to research the role of wearables in clinical trials this quarter. While sensor-enabled devices have increasingly featured in a variety of research projects and studies, their efficacy and accuracy remains a point of debate, and Parexel and Sanofi hope to investigate that question. Together, Sanofi and Parexel are leveraging their respective clinical, regulatory, logistical and technical expertise to determine how wearables can optimize data collection and study performance, ultimately resulting in faster drug development.
Shire Pharmaceuticals is taking another approach to innovating research, teaming up with online patient network PatientsLikeMe to develop digital communities and create research opportunities for people with highly specialized, often underserved conditions. Through the multi-year collaboration with Shire, the two companies will focus their efforts on creating more opportunities to connect patients with rare diseases through PatientsLikeMe’s platform, which allows anyone with a chronic condition the opportunity to track and share symptom and treatment experiences and contribute data for research.
The quarter also saw Japanese pharmaceutical company Otsuka and startup Proteus Digital Health make a second try for FDA clearance for the first ever drug with a bundled sensor. One year after the FDA declined to approve the new sensor-embedded formulation of antipsychotic drug Abilify, the companies are giving it another shot, resubmitting the application with additional information. As before, the application is a New Drug Application (NDA) — both the Proteus system itself and Abilify are already FDA cleared and approved, respectively. The companies expect to hear back by Q4.
The rest of the quarter’s pharma news had to do with the launch of new apps and/or connected adherence devices from various pharma companies.
Roche chose to up its app game late in the quarter through acquisition, snapping up longtime partner mySugr. Under the agreement, mySugr will continue to function as a separate legal entity, but will serve as the central point of Roche Diabetes Care’s patient-focused digital health services. mySugr, which was founded in 2012, is now present in 52 countries spanning 13 languages. People with diabetes use the mySugr GmbH app and service for coaching, testing trips and automated data tracking thanks to integration with a wide variety of connected devices.
In Japan, several pharma companies tapped Japanese startup Welby to help build their apps. Welby will develop an app for irritable bowel disease patients with Johnson & Johnson subsidiary Janssen; an app for pulmonary arterial hypertension (PAH) patients with Japanese pharma company Nippon Shinyaku, and an app for rheumatoid arthritis patients with UCB Japan. Welby works with at least 10 pharmaceutical companies altogether, making apps for lifestyle-related illnesses, chronic pain, central nervous system diseases, oncology, immunology, and rare diseases.
Sanofi quietly received FDA clearance in April for a smartphone app with a built-in insulin dose calculator. According to FDA documents, the app, cleared at the end of March, is called My Dose Coach. A pending trademark application gives a more in-depth description of the app, describing it as “downloadable software in the nature of a mobile application for use by patients with diabetes, for calculating and monitoring insulin dosages”. The trademark application also suggests the app will contain some kind of database of diabetes information.
Synergy Pharmaceuticals launched an interesting app for people with Chronic Ideopathic Constipation, an educational app that features a team of animated emojis called The Poop Troop. The free keyboard app, available on the App Store and Google Play, features a cast of anthropomorphic turds representing different stages of the bowel movement continuum, from constipation to normal to diarrhea. The aim of the app, which is part of Synergy’s Confront Constipation initiative, is to spark more productive conversations in hopes of improving treatment. Synergy focuses on research and development of new therapies for a range of gastrointestinal conditions, so the app could help people with CIC and their doctors better understand how they are responding to medication.
One the device side, Bayer received FDA approval for a connected auto-injector for relapsing-remitting multiple sclerosis medication and companion app. The device is called the Betaconnect Electronic Autoinjector and the app, due out in July, is myBetaApp. The Whippany, New Jersey-based pharma company didn’t clear the app and device through the 510(k) medical device pathway; instead the agency approved a supplemental Biologics License Application for the drug, Betaseron.
And Crystal Lake, Illinois-based Aptar Pharma is teaming up with digital health startup Kali Care to develop a new way of measuring adherence to eye drops in clinical trials. Because they are somewhat onerous to use, eye drops have even lower rates of adherence than other medications. Kali Care, based in Silicon Valley, makes a small sensor that can be installed in a container for eye drop medications.
Finally, Merck and Amazon Web Services teamed up to launch a developer competition that plans to harness artificial intelligence for people with diabetes. Dubbed the Alexa Diabetes Challenge, and powered by Luminary Labs, the contest aims to incent startups and individual developers to create apps that harness Amazon’s Alexa voice-enabled technologies particularly for patients recently diagnosed with Type 2 diabetes. The contest just recently announced its five finalists.