Marriage of Pharma & Tech Yields Benefits for Patients
It is no wonder pharmaceutical companies are looking to enter new health care territory. In 2016 there were only 22 new drug approvals in the United States, returns on investment continue to fall,1 and pricing pressures continued to mount. At the same time, the cost of bringing a new drug to market—a process that can take many years with no assurance of success—rose to over $2 billion.
To compensate for this uncertainty, drug makers are diversifying their portfolios by partnering with technology companies and embracing innovative products such as connected data-gathering medical devices and platforms that collect and analyze patient data.
It’s a lucrative space, according to Rock Health, a venture fund focused on digital health that reported funding of $4.2 billion in 2016. The most funded categories are genomics and sequencing, analytics and big data, wearables and biosensing, telemedicine, and digital medical devices.2 Drug makers hope these will help them amass more (and more accurate) patient adherence data, offer personalized treatment advice, manage chronic diseases better, provide medical alerts and reminders, and analyze data.
Novartis, considered a leader in the adoption of digital health technology, has formed partnerships with many technology firms to benefit both patients and the company.
“Smart technology, wearables, and sensors are increasing our ability to gather more robust data around patients’ responses to medications, their adherence to prescribed regimens, and disease progression,” said Vasant Narasimhan, MD, global head of drug development and CMO for Novartis. “The proliferation of connected sensors also enables health care companies to improve the measurement of clinical end points, which reduces the burden on patients by allowing us to measure those end points from the patient’s home.”**
A vibrant segment of device development is inhalers that monitor use by patients with asthma and other respiratory diseases. Both AstraZeneca, maker of Symbicort, and GlaxoSmithKline, which pioneered its Ventolin inhaler in 1969, are developing these “smart inhalers.” Generics manufacturer Teva Pharmaceuticals bought Gecko Health Innovations in 2015 to access its CareTRx platform for the management of respiratory diseases. By using a clip-on sensor that connects to its inhalers, CareTRx data analytics capability provides alerts to help patients manage their disease.
Novartis plans to launch a smart inhaler with an integrated sensor in 2019.3 “Novartis is the first pharma company in respiratory medicine to offer a completely integrated and connected delivery device,” said Narasimhan. The firm has partnered with Qualcomm to develop sensors for its Breezhaler, a wireless inhaler for patients with chronic obstructive pulmonary disease. Patients and their doctors will have access to real-time health and adherence data, transmitted wirelessly via mobile applications and the data cloud.
For diabetics, keeping track of blood glucose levels in hand-written logs can be onerous. Tech companies such as Livongo and Medtronic market glucose monitors that send data wirelessly to insulin pumps, where it is recorded for reference. The information can be uploaded and stored in the cloud, and mined for patterns that allow patients and their health care providers to better manage their disease. Medtronic also has an app that collects data from diabetics on their exercise and carbohydrate consumption. IBM Watson, a cognitive computing platform, analyzes the data to predict potential hypoglycemic events hours in advance, allowing patients to avoid harm.
Novo Nordisk, a major producer of insulin that began its partnership with IBM Watson Health in 2015, began to collaborate with software company Glooko in 2017 to develop a diabetes management app that will continuously monitor blood glucose levels. The data is sent to Watson to record the effects of insulin and measure drug adherence.9 ,10
Verily Life Sciences (formerly Google Life Sciences) began work with Alcon, Novartis’s ophthalmic division, in 2014 to research “smart ocular devices.” The companies are investigating two groundbreaking types of contact lenses: One could correct presbyopia, or age-related farsightedness. Another version is being planned to monitor glucose levels in diabetics’ tears.4 Lens design allows tear fluid to reach embedded sensors that measure blood sugar levels. A microscopically thin wireless antenna will transmit the information to an external device.7 Building on its expertise in miniature electronics, data analysis, and software development, Verily also launched Onduo, a joint venture with Sanofi, a leader in the global diabetes market, to create an as-yet-undefined management and treatment program for type 2 diabetes.5
- 1Deloitte. “Measuring the Return from Pharmaceutical Innovation 2016.” https://www2. deloitte.com/uk/en/pages/life-sciences-and-healthcare/articles/measuring-return-frompharmaceutical-innovation.html
- 2Tecco, H. “2016 Year End Funding Report: A Reality Check for Digital Health.” Rock Health. https://rockhealth.com/reports/2016-year-end-funding-report-a-reality-check-for-digitalhealth/
- 3Reuters. “Inhaler Makers Want to Watch Every Breath You Take.” Fortune, 20 July 2016. http://fortune.com/2016/07/20/smarter-connected-inhalers/
- 9Levine, Brian, and Adam Brown. “Novo Nordisk and Glooko to Develop Digital Diabetes Tools.” Diatribe, 30 January 2017. https://diatribe.org/novo-nordisk-and-glooko-developdigital-diabetes-tools
- 10Mack, Heather. “Novo Nordisk Teams Up with Glooko for Digital Diabetes Management.” Mobi Health News, 9 January 2017. http://www.mobihealthnews.com/content/novo-nordiskteams-glooko-digital-diabetes-management
- 4Verily. “Smart Lens Program.” https://verily.com/projects/sensors/smart-lens-program/
- 7The Medical Futurist (TMF). “How Will the Digital Contact Lens Help Diabetes Patients?” http://medicalfuturist.com/googles-amazing-digital-contact-lens-can-transform-diabetescare
- 5“Sanofi and Verily Life Sciences Announce Launch of Onduo, a Joint Venture to Develop Comprehensive Diabetes Management Platform.” Press release. 12 September 2016. https://static.googleusercontent.com/media/verily.com/en//press/articles/Onduo.pdf
In addition to implanted devices such as pacemakers, which have been used for years to correct irregular heartbeats, deep-brain electrical stimulation has also been effective in the treatment of Parkinson’s disease and severe depression. To help control appetite in those struggling with obesity, EnteroMedics has developed vBloc, a pacemaker-like device implanted under the skin that sends electrical signals to the vagus nerve, which helps control stomach emptying and tells the brain when the stomach feels full.8
Research is showing that bioelectronics stimulation can also treat chronic diseases such as diabetes, asthma, and arthritis without the use of chemicals or proteins. Galvani Bioelectronics is developing miniaturized electrical devices that will wrap around nerves to deliver these electrical impulses.
“Existing devices target large areas of tissue indiscriminately,” said Kristoffer Famm, President of Galvani. “Our objective is to home in on specific groups of neurons within circuits. We believe that recent scientific advances have made it possible to create the potential to develop more precise bioelectronic medicines.”
Famm says that these devices will affect individual nerve fibers or brain circuits to modulate the neural impulses controlling the body, repairing lost function and restoring health. “They could, for example, coax insulin from cells to treat diabetes, regulate food intake to treat obesity, and correct balances in smooth muscle tone to treat hypertension and pulmonary diseases.”
The model for creating and marketing digital technology products can sometimes clash with pharmaceutical firms’ traditional model, which involves spending years on R&D to develop a new drug, followed by regulatory approval, production, and marketing. In contrast, digital products typically undergo rounds of improvements and upgrades that continue after launch. While upfront costs are typically lower and development time shorter, the profit from digital devices is much smaller than for blockbuster drugs. The question of who controls patient data is an additional concern; pharmaceutical firms worry that technology companies are gaining access to large amounts of information about the behavior and outcomes of patients who use their drugs.6
Despite the challenges, Novartis remains bullish. “Our ambition is to harness these technologies to make the drug development process better, faster, and cheaper,” said Narasimhan. “We’re partnering with tech companies small and big at every step of the development chain, from identifying patients to redefining the role of trial sites, designing novel endpoints using sensors and wearables, and leveraging data to improve our operations.“Enhancements in drug development like these will only come to life through collaboration across the health care and technology spaces. It is crucial that we continue building ecosystems of collaborative science, and foster seed investments and partnerships with incubators for revolutionary enhancements to drug development. Partnering with best-in-class experts and leaders in other industries will be critical to successful scale-up of these technologies in the drug development arena.”
- 8US Food and Drug Administration. “FDA Approves First-of-Kind Device to Treat Obesity.” 14 January 2015. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm430223.htm
- 6Neville, S. “Digital Disrupters Take Big Pharma ‘Beyond the Pill.’” Financial Times, 24 April 2017. https://www.ft.com/content/d7a60642-0361-11e7-ace0-1ce02ef0def9