The future of speech biomarkers: transforming psychiatric disorder detection.

1. ki:e
ki:e
ki:elements | pioneers in speech biomarkers
ki:elements
The Future of Speech Biomarkers:
Transforming Psychiatric
Disorder Detection

2. ki:e
ki:e definition of a speech biomarker
2
2
patient-facing
front-end
prepare predict
extract
speech probe
patient
OPERATIONS
concept of interest
meaningful aspect
of health
compound
HEALTHCARE
Biomarkers measure indicators of normal biological processes, pathogenic processes, or
responses to an exposure or intervention. If this biomarker is collected using a digital
sensing product, it’s a digital biomarker. If this sensing product captures speech, we call
it a speech biomarker.

3. ki:e
Co-development across the clinical trial
lifecycle (aim: biomarker approval)
3
Consult & Design
Conceptualize &
Plan
Verify & Validate Approve
• Select and position valuable
endpoint
• Determine COA vs. biomarker
• Review of literature and
available technology
• concept for system
integration of future
endpoint (with additional
tech vendors)
• provide training material for
trial staff on technologies
• develop study protocol
• Conduct (interim) analysis
• move from exploratory
endpoint in phase 1 trial to
secondary/tertiary endpoint
in further phases
• Help with regulatory
submission
• License biomarker
1 2 3 4
Speech biomarkers allow for remote, inexpensive, ecological trial
assessment and can be implemented across the clinical trial lifecycle.

4. ki:e
Digital innovation advantages
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1.Speech extracted during task performance is non-invasive
2.Pre-screening tool for clinical trial participation and
enrollment
3.Scalable for different neurological conditions and
applications
4.Based on scientific evidence and validated use cases
5.Flexible integration with other solutions such as a
landline call-bot or phonebot; ecologically valid

5. ki:e
ki:e and J&J speech biomarker
collaboration
5
Therapeutic
areas
ki:elements projects with pharma
(selective cases)
ki: vision
Alzheimer's Disease or
Dementia
MCI cognitive biomarker Biomarker Co-Development MCI
Pre-clinical AD (joint study: academia +
pharma)
Biomarker Co-Development
preclinical AD
In a clinical study, selected sites Phone-based pre-screening

6. ki:e
Speech biomarker assessments vs. typical
clinical trial enrollment
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Reduction of patient and trial site burden with the same trial inclusion rates through better pre-selection