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"Digital Biomarkers of Neurological Function”
Neuro-focused prescription digital health companies are taking aim at a range of diseases from psychiatric and mental health disorders to neurodegenerative diseases. In this excerpt from our September 28 feature, “Digital Taps Into Neurological Function,” Mark Ratner talks with William Marks, MD, about Verily Life Sciences’ activities in the field.
One of digital technology’s significant contributions to exploring and treating neurological diseases stem from its potential to provide better, objective measurements of neurological function. William Marks, MD, Head of Clinical Neurology at Verily Life Sciences, agrees that the subjectivity of the current measurements of neurological function and disease frustrates clinical neurologists and needs improvement. With cardiovascular and metabolic disease, even oncology, reasonably clear-cut markers for disease exist. Not so in neurodegeneration. “You have behavioral issues, cognitive problems, motor problems, visual problems, sensory problems that can make it difficult to disentangle the root cause of these disorders,” he says. And because such measurements are often taken in a clinic visit or a research study visit, they don’t represent the real-world function of people. “You can’t close the loop on therapy delivery unless you can really measure the disease and its response to therapy,” he says.
Verily is focusing on better ways to measure key components of brain and nervous system function: movement, cognition, mood, sleep, etc. with the idea that many are altered in a variety of diseases. The company is using Parkinson’s Disease (PD) and multiple sclerosis as proving grounds for its measurement technology, trying to gain a deep understanding of those conditions not only to develop better therapies for them but also to translate more broadly across neurological disorders. In PD, patients not only exhibit altered movement but also altered cognition, mood, and sleep. Cognitive behavioral issues and sleep issues are also common in dementia, epilepsy, and migraine, and in multiple sclerosis. “You see different types of alterations in these core functions,” Marks says. To manage these disorders demands having a better ability to measure them. “We largely are developing digital tools for this purpose, to be coupled with molecular capabilities,” he says. “It’s also our thesis that unidimensional data will never be as powerful as multidimensional data, so bringing together the endotype (what’s going on at the molecular level) with the digital phenotype and the clinical phenotype and the imaging findings will give us a deeper picture of health and disease and the transition between the two,” he says.
Take tremor. “I can describe it, say it affects the left hand more than the right hand, that it is large amplitude, has a certain frequency,” Marks says. During a 30-minute clinic visit, it may be present half the time and the patient may say it is mainly at night or in conjunction with certain activities. A digital technology can provide more refined mathematical measurements of tremor amplitude, and with the continuity of measurement a wearable device can provide, give the full picture of the scope of the phenomenology, when and how often is it occurring, and the pattern, he says. Add to that sensors that look at not just physiology but a person’s interactivity with the world and the environmental factors that provide the contextual information. “One could imagine totally new constructs that might be a better real-world reflection of the impact of a disease or response to therapy,” Marks says.
That should pique the interest of medtech companies with neuromodulation devices, for example. With an implantable deep brain stimulating device, the extent to which it is working may not be clear because of crude measures, making it difficult to document a trend over time, Marks says. “We and the field are first of all going toward more quantitative measures: devices that collect data either more continuously or more often; that are multi-dimensional in nature; and that have not only physiological but contextual information.” That translates into a real-world picture of patient function and outcomes, he says. “If I were a medical technology company, I would want to demonstrate a real-world impact of the therapy with payors by integrating these different signals to represent real-world impact.”
Verily has also teamed up with GlaxoSmithKline PLC to form Galvani Bioelectronics Ltd. to develop bioelectronic devices for neuromodulation of peripheral nerves. It is not tackling psychiatric disorders. Instead, the joint venture is working through the nervous system to tackle a slew of chronic diseases centered on organs or systems in the main body cavity: inflammatory, cardiovascular, metabolic, and respiratory conditions.
Bioelectronic medicines send an electrical signal through the nervous system. “It’s a highly connected and digital therapy solution,” says Galvani president Kristopher Famm, PhD. “The connectivity in a bioelectronic therapy system is substantial.”
“We are using the nervous system as a very targeted way to get to particular end organs and how they affect dramatic things in the body like airway tightness or blood pressure or insulin release,” Famm says. By targeting a nerve that only goes to one organ, the approach should have few side effects. “It is a local, well-controlled effect,” Famm says, as opposed to trying to control neural circuits going to the brain that have behavioral or cognitive effects.
Galvani is drawing on Verily’s expertise in integrated circuits and electronic designs. “We are well configured with smart devices that engage with the therapy that is being delivered,” Famm says. While current neuromodulation devices already gather data, Galvani’s goal is to obtain more and more recordings of the effect of neuromodulations on the body or what the biological state of the patient is in the first place across a range of diseases. That could mean detecting the effect of stimulating the nerve—it’s important to be able to detect the effect of a therapy in real time—then be able to calibrate it within a millisecond.
The long game is to record more continuously changes in the disease and then respond to them, Famm says. Plus, there is opportunity to track treatment and disease condition. “You have an engaged patient, tracking with a smartphone, where the data could be integrated very easily with your treatment as a time-stamp,” he says. Bioelectronic medicines, like other categories of digital tools, also provide the agility of being able to analyze performance and quickly introduce improvements to therapy, to improve outcomes.
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Further Reading in MedTech Strategist
3D Manufacturing – “Carbon: Bringing a Revolution to the 3D Revolution,” by David Cassak
Start-Ups to Watch—“EIT Emerging Implant Technologies: The Opportunity of 3D Printing,” by Wendy Diller
Industry Spotlight – “Materialise NV: Will 3-D Printing Disrupt Medtech?” by David Cassak
Musculoskeletal Oncology — “Onkos Surgical: Jumpstarting a Specialty Medtech Company,” by David Cassak
Industry Outlook—“Technologies to Watch in 2017,” by the MedTech Strategist Editorial Team
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