Pharma companies turn to wearables to improve R&D
The Michael J. Fox Foundation, Pfizer, Apple, and IBM are some of the organizations and companies testing out mobile technology for patients with Parkinson's. Photo credit: Creative Commons/BTNHD Production
A number of drugmakers are partnering with technology companies and patient groups to test the use of wearables in patients with Parkinson's disease.
Approximately 40% of Parkinson's patients experience motor fluctuations within four to six years of the disease's onset, and the fluctuations increase by 10% each year thereafter, according to the Parkinson's Disease Foundation. Tremors, slowness, and stiffness are early indicators of the disease, and medications are often prescribed to help combat these symptoms.
That's why drugmakers, researchers, and technology companies are incorporating wearables in clinical studies to advance research and development of Parkinson's disease treatments.
The Michael J. Fox Foundation for Parkinson's Research teamed up with specialty drugmaker Cynapsus Therapeutics and Intel to incorporate wearable technology in a Phase-III clinical trial of APL-130277, an experimental drug being tested to treat “off” episodes, which are periods of time when the symptoms of the disease return even though the patient is still on a therapy.
“Parkinson's is a disease whose symptoms are primarily related to movement and the incapacity of movement,” said Cynapsus CEO Anthony Giovinazzo. “If we can better measure when patients are on and off, what's happening in their body, and be able to analyze some things more than the human eye can interpret, it allows us to be more specific in the design of the treatment and understanding of the problem.”
APL-130277, a sublingual film formulation of apomorphine, is the only approved drug to convert Parkinson's patients from "off" to "on" in the U.S., Japan and several other countries, said Anthony Giovinazzo, CEO of Cynapsus (pictured, left).
Pfizer, UCB, Apple, and IBM are just a few of the other companies testing out mobile technology for patients with Parkinson's. Apple's ResearchKit and Pfizer's and IBM's wearable sensor system are both being used to gather data in real time to better understand the disease. Last June, an Australian health tech company called Global Kinetics received FDA approval for the Personal KinetiGraph, a wristwatch-like device that records data about a patient's movement. UCB is also working with MC10 on a wearable sensor patch that monitors the symptoms of Parkinson's disease and utilizes a patient diary app.
The unpredictability of Parkinson's disease's off episodes can be both debilitating and dangerous for patients, said Maggie McGuire Kuhl, medical research communicator at the MJFF. “We had one person on our patient council who was an electrician,” she recalled. “If he were to go off, it would be dangerous.”
Participants in the APL-130277 study are using a wearable device and smartphone application developed by the MJFF and Intel to gather data and send it to a secure cloud platform. Researchers are using that data to gain insights about the disease and potential drug reactions that can impact movement and perspiration. The organizations expect the studies to be completed later this year.
“The symptoms vary day to day,” said McGuire Kuhl. “Most data comes from clinical appointments and diaries, which are burdensome for patients. Using the wearable will contribute to research and tell us what their day looks like.”
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The smartwatch contains an accelerometer that can detect how long a patient experiences an off episode, and it also has an alarm, which reminds patients to take their medication. It can also analyze movement.
“When a hand is shaking, it could be shaking for a bunch of reasons,” said Ketan Paranjape, general manager of life sciences at Intel. “Maybe your tremors that day were because of something else like brushing your teeth. Maybe the person doesn't have Parkinson's disease, but there is a high risk, so preemptively you can predict Parkinson's disease.”
The device does not replace in-person research and will likely be used to complement the traditional way of conducting research, insisted McGuire Kuhl. The smartwatch allows patients who don't live near the research site to participate remotely, providing a more objective quantitative look at data from a large pool of participants, she added.
Participants in the Parkinson's APL-130277 study are using a wearable device and Fox Insight smartphone application developed by the MJFF and Intel to gather data and send it to a secure cloud platform.
When it comes to wearable technology, fitness trackers such as the Fitbit and Apple Watch are already gaining in popularity among consumers simply looking to track their health in their everyday lives. According to an International Data Corp report, vendors shipped 78.1 million wearable devices in 2015, up 171.6% compared to 2014. Fitbit, the top wearable vendor, reported a 48.5% boost in revenue to $1.86 billion in 2015 as well as 26.9% market share.
“You now have an infrastructure where data is captured and transferred to a large storage system and is made available to researchers, physicians, or nurses,” added Paranjape. “And then the holy grail is that this data should be sent back to the patient with the results. The bottom line is getting the patient into this conversation.”
Feedback has been receptive so far, both from researchers and from patients, according to McGuire Kuhl. “People want to contribute to studies, but barriers such as geography limit them from doing them,” she said. “People say they don't notice it — they have been sleeping with it even.”
The hope is to learn more about the nuances of Parkinson's disease to illuminate new areas of research, said McGuire Kuhl. “We're learning about people's quality of life and we'll have a greater understanding of therapies and their impact on people and their ability to enjoy their lives,” she said.
Drugmakers such as Biogen are already using the Fitbit to better understand multiple sclerosis in patient studies. In the future the technology could be extended to be used as a tool for preventative care and in Alzheimer's disease research, added Paranjape.
“They're going to improve in the next generations,” said Giovinazzo. “Think about where we were five years ago with cars. They had an engine, lights, doors, and AC. Today, they have GPS navigation, they can parallel park themselves, and [they] can stop if they have an accident. It allows an evolution for a particular industry, as will be the case for devices used in medical treatments like a wearable watch.”