Lundbeck making strides in the field of digital biomarkers

A collaboration between Lundbeck and French company FeetMe tackles this question with the use of sensor shoe soles that monitor walking ability in people living with Parkinson´s. FeetMe's shoe insoles with digital capabilities can help us obtain rich and objective data sets on critical motor functions. In people living with brain diseases, therapeutic interventions can be evaluated by using digital biomarkers such as FeetMe-derived measures. These biomarkers may serve as supportive and objective outcome measures and may additionally help provide a more refined diagnosis and accurate staging of the disease.

Eighteen pressure and motion sensors placed in a convenient shoe sole, one for each foot, will collect kinetic and kinematic data on people’s gait patterns. The analysis of these data provides ample information on the neurological condition to assess the current progression of the disease, objective symptom monitoring and whether currently administered treatments are successful or not.

Earlier this year in an interview with Ingeniøren, a Danish trade magazine focusing on developments in technology and science, Ingrid Sofie Harbo, VP of biometrics in Lundbeck, said: "It means a lot to patients when their balance is affected and there is a real risk to fall. We have found an opportunity to measure balance in everyday life in the patient's own home, or when they are out for a walk."

This technology may eliminate the need for subjective assessments, which can often lead to missed or latediagnoses and imprecise prognoses.

Digital biomarkers are an essential element in Lundbeck’s overall strategy to digitize and possibly further decentralize our clinical trials. By combining new approaches with the existing scientific and innovative competencies of the R&D organization, we have great potential to bring improvements that can help us better address the high unmet needs in brain diseases.

We are actively investigating how we can incorporate the FeetMe technology to generate new insights towards Lundbeck’s commitment to providing transformative outcomes to people living with brain diseases. Ultimately, at the heart of this technology lies a true patient-centered need.

Generally, biomarkers are naturally occurring characteristics, like the presence of a gene or a protein, that can easily and reliably help identify a disease, symptom, patient subpopulations or treatment response. A digital biomarker, meanwhile, is defined as the successful collection of quantifiable data for a certain behavior using digital technologies.

In the case of the sensory shoe insoles, data will be collected on several features of a person’s gait to assess motor control and overall performance. These include length of each stride, trajectory of the center of pressure, swing and stance phases, where do patients apply pressure when they step and how do they distribute that pressure during heel to toe rolling motion. When put together, these parameters inform clinicians on whether the patient is progressively losing balance due to the advancement of the disease, or conversely, whether the patient is regaining balance as a result of successful treatment.

The project is still in its early days with more research and optimization needed before reaching the final goal when it comes to the seamless use of digital biomarkers. Nonetheless, through these efforts, Lundbeck opens the door to a brighter future, where patients are treated based on reliable, objective data collected for each individual in real world conditions with less bias. Granted the success of the project, the concept can and will be even further expanded to other neurological disorders as well.