Digital Biomarkers

Digital Biomarkers 2017-10-11T10:47:17+00:00

The arrival of connected digital technologies, such as wearable biosensors and mobile devices that enable the passive measurement of parameters such as sleep, activity and heat rate, has the opportunity to revolutionize the capture of data from clinical trial participants.

Such technologies present the possibility to collect data continuously and extract from the data new digital biomarkers that are more precise, patient-centric, clinically meaningful and objective compared to current methods used in research, such as subjective rating scales and patient diaries.

What are we doing at IXICO

We are combining the best emerging wearable technology together with our digital platform and our scientific and regulatory expertise. We are partnering with biopharma companies to discover and clinically validate new digital biomarkers for deployment in regulatory compliant clinical trials; fit for use in the specific patient populations.

IXICO is developing and validating new deep learning algorithms to analyse wearable biosensor data for specific neurodegenerative diseases. These disease-specific algorithms can improve the sensitivity and specificity of standard algorithms to measure physiological parameters such as sleep, activity and circadian rhythm. To support our innovation, we have funded a number of studies to gather actigraphy data, alongside other clinical measures.

Regulatory environment

Today, digital biomarkers provide pharma companies with supplemental, contextual information to arrive at clinical trial Go/No Go decision more confidently and efficiently.

Our strong regulatory track record and digital technology capabilities means that we are at the forefront of developing and validating digital biomarkers.

As a new and emerging technological advancement, we are actively participating in consortia and engaged with regulatory bodies to continue to validate digital biomarkers and develop the pathway to support the use of digital biomarkers as endpoints in clinical trials to support regulatory approval.

Coalition Against Major Diseases 
(CAMD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer’s disease (AD) and related neurodegenerative disorders.

IXICO’s data and regulatory scientists are enabling the following CAMD initiatives:

  • The qualification of low baseline hippocampal volume for use in Alzheimer’s disease (AD) clinical trials for selecting subjects as having a high probability of being in the prodromal stage of the disease
  • Progress the regulatory landscape for the use of Digital Biomarker Measures as endpoints in clinical trials to support regulatory approval of new medicines to treat people with Mild Cognitive Impairment (MCI)

To speak to one of our experts and find out more