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Stephen E. Zweig, Ph.D. CEO, CliniSense Corp.

Advances in drug stability monitoring. Stephen E. Zweig, Ph.D. CEO, CliniSense Corp. A chain is as strong as the weakest link. Problems can potentially occur at any time during storage, causing “hidden damage”

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Stephen E. Zweig, Ph.D. CEO, CliniSense Corp.

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  1. Advances in drug stability monitoring Stephen E. Zweig, Ph.D.CEO, CliniSense Corp. CliniSense Corporation

  2. A chain is as strong as the weakest link • Problems can potentially occur at any time during storage, causing “hidden damage” • Manufacturer’s responsibility doesn’t just stop on initial delivery – it continues until the product is actually used! CliniSense Corporation

  3. Where hidden problems can occur • Initial shipment: between different storage sites, each with separate temperature recorders • In the health care facility • Receiving • Transport to one or more storage sites • Transport to point of care site • Transport to patient • Time delay before administration • Patient mishandling of drug delivery devices CliniSense Corporation

  4. Biotherapeutics are delicate drugs • Much larger and more complex than traditional pharmaceuticals • Composed of unstable proteins with a precise structure • Easily damaged by unfavorable temperature history during storage CliniSense Corporation

  5. Even insulin has temperature problems Insulin Shelf-life • Insulin is a very temperature stable biotherapeutic • A graph of storage life vs temperature shows a “saw tooth” peak • The product dies at both temperature extremes 1000 100 Months 10 1 0.1 -20 0 20 40 60 Temperature (C) CliniSense Corporation

  6. < 0o C Freezing Protein denaturation Formation of aggregates Loss of functional activity Formation of potentially hazardous immunogenic byproducts > 8o C Chemical side reactions Protein denaturation Formation of aggregates Loss of functional activity Formation of potentially hazardous immunogenic byproducts Effect of temperature storage extremes CliniSense Corporation

  7. Smart packaging vs dumb packaging • Smart packaging can guard against human errors in handling, and accidental temperature abuse. • Is traditional dumb packaging simply a relic from an earlier era? Does it pass modern failure modes analysis? CliniSense Corporation

  8. An ideal storage monitor: • Accurate and effortless to read • Show remaining life (gas gauge-like display) • Outs thermal history record upon request CliniSense Corporation

  9. Electronic Previous time-temperature monitors • Chemical indicators are not flexible or accurate • Electronic temperature loggers are accurate, but don’t show shelf-life. • Temperature alarms only show extreme “out of bounds” conditions Chemical CliniSense Corporation

  10. LifeTrack RFID LifeTrack technology demonstrator LifeTrack™ Technology • Monitors and analyzes temperature history • Custom programmed to exactly match the sensitivity curve of any pharmaceutical • Instantly shows all types of temperature abuse CliniSense Corporation

  11. Small # of withdrawals per hour Low temperature High temperature High # of withdrawals per hour Stability bank "B" The stability bank algorithm CliniSense Corporation

  12. Stability points per hour Insulin Shelf-life 1,000,000 1000 100,000 100 10,000 Points Months 1,000 10 100 1 10 1 0.1 -20 0 20 40 60 -20 0 20 40 60 Temperature (C) Temperature (C) Stability calculation exampleB = 165984– Σ P(temperature) time 0 CliniSense Corporation

  13. Sample LifeTrack profiles • Each different stability profile produces a different P(temp) function CliniSense Corporation

  14. Evaluating LifeTrack technology • Is our stability data adequate? • Customers like? • FDA requirements? • How can I do a quick feasibility test? CliniSense Corporation

  15. Thermistor +/- good bad display Lifetime bar Battery door Infrared LED Programming & expansion Port Battery (3 yr life) LifeTrack Technology Demonstrator CliniSense Corporation

  16. Inside the unit • Low-cost electronics • Simple construction • Designed for high production volumes • Digital watch example • Modules cost < $1.00 • Ultimate costs in $2.00 to $3.00 range CliniSense Corporation

  17. LifeTrack Demonstrator Display • Shows “+” when product is good, “-” when product has expired • Lifetime indicator bars decrease as the lifetime is used up CliniSense Corporation

  18. Programming a unit • Enter the stability data into an Excel spreadsheet model • Transfer parameters to LifeTrack program • Load LifeTrack program into LifeTrack device CliniSense Corporation

  19. Demonstrator Data Output • Downloads temperature statistical data via IR cable to an RS232 port • Only one bit needed to tell good/not good, additional bits tell you how and why • Highly compatible with the limited data transmitted by RFID tags CliniSense Corporation

  20. Data output example: The entire relevant history record in only 150 bytes Material: Biotherapeutic ID: 12345678 CliniSense Corporation

  21. Using LifeTrack Technology • Provide biotherapeutic stability data for multiple temperatures (e.g < 0, 4-8o C, 25o C, etc.) • CliniSense will generate one or more provisional algorithms, request approval, and return flash programmed LifeTrack technology demonstrator units for evaluation within a few days • CliniSense will work with you to embed this technology into your preferred drug delivery device or other type platform, license as needed CliniSense Corporation

  22. Smart biotherapeutic packaging Drug delivery devices • LifeTrack detects deteriorated product • Can be embedded into drug delivery devices • Accurate and easily customized LifeTrack RFID LifeTrack technology demonstrator CliniSense Corporation

  23. Injection pens LifeTrack RFID LifeTrack technologydemonstrator LifeTrackTM Technology Detects all types of improper storage

  24. Recent publications • Zweig SE: Advances in vaccine stability monitoring technology, Vaccine, 2006 (in press)  • Zweig SE: 21st century electronics for 21st century drugs, Drug Delivery Reports, Spring/Summer 2006 • Zweig SE: From SmartTags to Brilliant Tags: Advances in Drug Stability Monitoring, BioPharm International, November 2005, 36-44. • Zweig SE: Technologies for monitoring IVD stability, IVD Technology 10(5) 59-63, June 2004 CliniSense Corporation

  25. Recent patents • Patent 6,950,028, Electronic Time-Temperature Indicator • Patent 7,096,090, Electronic time-temperature indicator and logger (basis for PCT filings) • Patent application 10/747,926  (pending) Method and device to reduce therapeutic protein immunogenicity CliniSense Corporation

  26. For more information • CliniSense website (www.clinisense.com) has many examples • Demo units available • Feel free to call (408) 348-1495 and ask questions CliniSense Corporation

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