A New Approach to Measure Adherence to Medicines Using Biomarkers and Sensors

Area of Science:

• Pharmacokinetics and Drug Development
• Biomarker Discovery
• Clinical Trial Methodology

Background:

• Poor medication adherence is a global issue, impacting chronic disease management and drug development by introducing variability in pharmacokinetic (PK) and pharmacodynamic outcomes.
• Adherence measurement is critical for advancing precision medicine and ensuring accurate drug efficacy and safety assessments in clinical trials.
• Current methods for tracking medication adherence are insufficient, hindering the development of effective interventions and reliable drug evaluations.

Purpose of the Study:

• To present a novel cross-technology platform for high-resolution measurement of medication adherence.
• To enable accurate back-calculation of ingested drug doses using pharmacokinetic modeling and biomarkers.
• To integrate adherence measurement seamlessly into existing drug development and clinical trial timelines.

Main Methods:

• Development of a platform combining pharmacokinetic (PK) models with PK biomarkers (genotyping/phenotyping) to understand dose-exposure relationships.
• Utilization of edible ingestion sensors (IS) to digitize and record the administration of orally administered medicines in controlled cohorts.
• Application of built PK models to back-calculate actual patient dosage based on observed drug exposure and patient data.

Main Results:

• The proposed platform integrates PK modeling with IS technology for precise adherence measurement.
• Dose-exposure data from fully adherent cohorts using IS enables robust PK model development.
• The platform allows for the back-calculation of ingested doses, addressing adherence variability.

Conclusions:

• This adherence measurement platform can be implemented within current drug development phases (Phase 1-4) without major process changes.
• The technology facilitates the development of both new drugs and companion adherence monitoring software.
• Accurate adherence measurement via this platform is essential for the realization of precision medicine and reliable clinical trial outcomes.