“The Coming RFID Revolution in Individual Dose Drug Packaging”

1. “The Coming RFID Revolution in Individual Dose Drug Packaging” Mark A. Niemiec Global Packaging Innovations & DDMS Holdings June 6, 2005

2. “We need new systems to monitor the use of drugs.” Explains acting Deputy Commissioner, FDA, Janet Woodcock Source: 2/7/05 Business Week “The Vioxx Fallout on the Hill” FDA Under Pressure! DDMS,LLC

3. RFID Provides Opportunity For New System DDMS,LLC

4. Drug Delivery Management System • Patented DDMS technology is being developed that will detect when a pill is removed from the unit dose drug package • “Real Time” monitoring using RFID technology • Additional “security circuit” to detect when pill is removed • Portable or fixed reader • Environmental sensors DDMS,LLC

5. Pharmaceutical Industry Facing Major Issues • Reduce clinical trial cost • Eliminate mistakes in hospitals • Implement track’n trace • Improve patient compliance DDMS/RFID packaging can provide solutions to all of these issues DDMS,LLC

6. Clinical Trial Cost Factors • Qualified patients - hard to find • Acquiring the data - manually • Accuracy of data - patient honesty • Non-Compliant patients - bias data DDMS,LLC

7. Electronic Compliance Packaging Making Inroads Into Clinical Trials • Two electronic compliance packaging systems already being tested: • cerepak – MeadWestvaco • Medic – Information Mediary Corp. • Both require downloading compliance data at later time DDMS,LLC

8. DDMS Can Reduce Clinical Trial Cost • DDMS provides “real time” patient monitoring • Electronic compliance data recording • More cost effective • Allows for intervention • Improves quality of data DDMS,LLC

9. Pharmaceutical Industry Facing Major Issues • Reduce clinical trial cost • Eliminate mistakes in hospitals • Implement track’n trace • Improve patient compliance DDMS/RFID packaging can provide solutions to all of these issues DDMS,LLC

10. Hospital Safety Major Issue • ’99 IOM Study – 98,000 deaths due to mistakes • Increases cost • FDA forced to take action • Have you been personally affected by mistakes? DDMS,LLC

11. FDA Addressing Hospitals Mistakes • Requiring “bar code” technology for drugs • Seen as first step • Labor intensive • Line-of-site required • Limited information • FDA aware of RFID potential DDMS,LLC

12. RFID Already Having An Impact In Hospitals • Asset management systems available • Exaver: Wi-Fi + RFID • Mobile Aspects: “smart cabinet” • Closed loop modular supply systems • RFID drug packaging logical next step DDMS,LLC

13. DDMS/RFID Takes Safety To “Pill Level” In Hospitals • “Real Time” monitoring of drug unit dose dispensing • Right drug, right time, right patient • Link data into patient file & billing • Compatible with overall RFID platform • Better inventory management (shelf life) • Deter theft DDMS,LLC

14. Pharmaceutical Industry Facing Major Issues • Reduce clinical trial cost • Eliminate mistakes in hospitals • Implement track’n trace • Improve patient compliance DDMS/RFID packaging can provide solutions to all of these issues DDMS,LLC

15. Improve Drug Supply Chain – Counterfeiting • Global Issue – 5-8% in US & growing • Billion $ impact on drug industry • Increased risk for consumers/patients getting low quality/adulterated drugs DDMS,LLC

16. Pharmaceutical Supply Chain - Disjointed • 3 major distributors 80-90% • Remaining distributors are small • Regulated by states • Reselling common practice DDMS,LLC

17. Improve Drug Supply Chain – Track'n Trace • FDA issues “compliance policy guide” • EPCglobal – Healthcare and Life Sciences Business Action Group • Successful 2004 eight month item level tagging test • HDMA supporting item level tagging goal = 2007 • Wal-Mart mandating class II tagging • Pedigree laws - Florida DDMS,LLC

18. DDMS Takes RFID Item Tagging To Next Level • It is the more expensive drugs that are targets • DDMS provides a “security circuit” that can detect if a pill is removed • Opportunity to track’n trace to the “pill level” DDMS,LLC

19. Pharmaceutical Industry Facing Major Issues • Reduce clinical trial cost • Eliminate mistakes in hospitals • Implement track’n trace • Improve patient compliance DDMS/RFID packaging can provide solutions to all of these issues DDMS,LLC

20. Patient Compliance Biggest Healthcare Issue • Drains $100 billion/yr from economy • 10% of hospital admissions are due to non-compliance • 23% of nursing home admissions • Only 50% of patients follow doctors orders • Asthma, depression, high blood pressure • Drug industry loses $ billions in drug sales Source: World Health Organization & Healthcare Compliance Packaging Council DDMS,LLC

21. Non-Compliance Problem Getting Worse • Major concern: “fear of side affects” • High cost of drugs • Preventive drugs require extended/life long regimen • Patients do not feel sick • We need new systems to help patient take their meds DDMS,LLC

22. DDMS Provides Real Time Compliance Solution DDMS,LLC

23. DDMS Advantages • Remind patients to take meds • Validates compliance – “real time” • Makes compliance data available to “stakeholders” • Cost effective solution for “post launch” trials DDMS,LLC

24. DDMS Development Status • Establishing development partners • Expect first prototype 2005 • Initial commercial trials 2006-07 DDMS,LLC

25. DDMS Patent Status • Three patents issued to date • July 2002 6,411,567 • June 2003 6,574,166 • Jan. 2005 6,839,304 • Additional pending US applications and corresponding foreign applications pending DDMS,LLC

26. DDMS Could Be The “Silver Bullet” Solution • Reduce clinical trial cost • Eliminate mistakes in hospitals • Implement track’n trace – pill level • Significantly improve patient compliance DDMS,LLC

27. For More Information About DDMS Reference: March/April Issue of RFID Product News article titled: “Pharma Focus: Driving Drug Delivery with RFID” Contact: Mark A. Niemiec President DDMS Holdings, LLC 904-543-1945 manpkg@aol.com DDMS,LLC

28. “The Coming RFID Revolution in Individual Dose Drug Packaging” Mark A. Niemiec Global Packaging Innovations & DDMS Holdings June 6, 2005