SMART™ in Disease Management

SMART drugs have numerous applications in Disease Management. Early candidates for SMART drugs are conditions where behavioral challenges make patient adherence especially critical, including management of cognitive impairment (Alzheimer's and related diseases), seizure disorders and certain psychiatric disorders.

Psychiatric Disorders - A SMART version of an antipsychotic drug would provide an unparalleled method for monitoring patient adherence, providing definitive proof of medication adherence and fool-proof reporting of non-compliance.
Cognitive Impairment - Management of Alzheimer's and similar cognitive impairment diseases would benefit from a SMART version of treatment drugs which would report via the breath on patient adherence, with the SMART system providing notification to caregivers or family in the event of non-compliance.

Other diseases where SMART drugs can benefit patients include diabetes, CHF, COPD, stroke and neurological diseases, where measuring patient adherence can be a key tool in determining efficacy of therapeutic agents.

Therapeutic Area	Product Rationale
Alzheimer's	Greater convenience for caregiver and patient
Epilepsy	Product would and document dose timing for physician management
Oncology	New generation of LT oral meds requires full adherence to work. SMART version will allow ADR monitoring, justify reimbursement.
Depression	Adherence will help clarify and separate any correlation between dose timing and AEs Morning dosing vs. night dosing recommendation needs to be followed (to activate drug action) Notable food effects mean dose ingestion must be carefully managed with respect to meals
Psychosis	"Perfect" adherence: Optimize dose, improve patient management Safer: self-reporting metabolic or CYP 450 impairments for ADR "warning flag" Provide definitive documentation of dosing for insurers, caregivers, trialists → enable positive incentives in intermittent compliers
Asthma/ COPD	Confirm that a full dose was received, metabolized Monitor for negative CYP450 conditions Increase efficacy through better dosing

Therapeutic Area

Product Rationale

Alzheimer's

Greater convenience for caregiver and patient

Epilepsy

Product would and document dose timing for physician management

Oncology

New generation of LT oral meds requires full adherence to work. SMART version will allow ADR monitoring, justify reimbursement.

Depression

Adherence will help clarify and separate any correlation between dose timing and AEs

Morning dosing vs. night dosing recommendation needs to be followed (to activate drug action)

Notable food effects mean dose ingestion must be carefully managed with respect to meals

Psychosis

"Perfect" adherence: Optimize dose, improve patient management

Safer: self-reporting metabolic or CYP 450 impairments for ADR "warning flag"

Provide definitive documentation of dosing for insurers, caregivers, trialists → enable positive incentives in intermittent compliers

Asthma/
COPD

Confirm that a full dose was received, metabolized

Monitor for negative CYP450 conditions

Increase efficacy through better dosing