the technology the missing link in biopharmaceutical sciences tm

13
The Technology THE MISSING LINK IN BIOPHARMACEUTICAL SCIENCES TM

Upload: anissa-lynch

Post on 23-Dec-2015

216 views

Category:

Documents


1 download

TRANSCRIPT

The Technology

THE MISSING LINK IN BIOPHARMACEUTICAL SCIENCESTM

“Anything that can be measured can be managed”

A basic principle

AARDEX

AARDEX

Advanced Analytical Research on Drug Exposure

Reliable assessment of drug exposure

Single point in time assessment

Continuous assessment over time

Biased •Pill counts •Pharmacy refill data

•Patient diary•Retrospective questionnaire

Reliable •Therapeutic drug monitoring (TDM)

•Electronic monitoring (EM)

Vrijens & Urquhart, 2004 Journal of Antimicrobial Chemotherapy

The MEMS® monitor

The MEMS 6 monitor is an electronic cap that shows the number of openings since the start of the current 24-hour period and of hours elapsed since the last medication event.

• Stores up to 3800 medication events in non-volatile EEPROM memory • Wireless data transfer, • Fits standard pharmacy bottles 38mm-400 thread closure, • Available with or without child resistant security, • Unique serial number identification is indelibly printed on the monitor and stored in its electronic memory, • Waterproof, • CE marked,• 18 months battery life.

Introducing advanced technology on monitoring adherence

Medication Event Monitoring System (MEMS®)

MEMS VI®

Events recording and storage

Communicator MEMS VI®

Communication device

www.viewcompliance.com

Internet

Need a simple but robust taxonomyOur web-based platform

Physician, Pharmacist

Sion, Switzerland

Anonymous, but drug-specific, aggregated database

Individual reports back to Physician, Pharmacist

FDA 21 CFR, 11 & HIPAA compliant

Internet

www.viewcompliance.com

Need a simple but robust taxonomy Log into the web compliance portal

EN / FR / D version

Need a simple but robust taxonomyIndividual compliance data report (forgetful patient)

Individual compliance data report (weekend effect)

Individual compliance data report (perfect patient)

Individual compliance data report (BID: evening variability)

Evolving Technology

• Over 400,000 patients monitored to date with the various version of MEMS (Medication Event Monitoring System)

• Currently used version (MEMS 6) has a proven track record on >140,000 patients

• >15,000 patients from controlled clinical trials with available data

– Data on >3 Million monitoring days

• Ongoing device development:

– MEMS 7 (Wireless)

– Polypharmacy

– Blister packaging

MEMS 6AARDEX®

AARDEX®

AARDEX®