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Intelleflex - Trust but Verify


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Kevin Payne presentation for Expeditors International seminar - October 2012

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Intelleflex - Trust but Verify

  1. 1. On-Demand Data Visibility and Cold Chain Logistics Kevin Payne Senior Director of Marketing SHM PowerPoint Template Guidelines - October 2012
  2. 2. A Rapidly Changing LandscapeOff-patent drugsIncrease in number of biologicsIncrease in value of biologicsComplexity of supply chainsShift to 3PLs90º in February, 60º in JulySFO to LHR, sure − SFO to RDU, not so muchePedigreeSerializationInferenceRFID proven safe for biologics SHM PowerPoint Template Guidelines - October 2012
  3. 3. The Cold Chain TodayExtensive efforts to ensure proper storage and handling • Validate and profile routes • Utilize specialized packaging • Create SOPs and perform QA auditing • Use temperature monitors for historical recordMost companies trust that their highly complex cold chains are working properlyHowever… • It is impossible to eliminate all of the variables • Packaging, delays, weather, lost/ignored loggers • At best, only forensic/historical data is available Bottom line: valuable product is being wasted The Primary Culprit: Poor in-transit data visibility for temperature management and traceability SHM PowerPoint Template Guidelines - October 2012
  4. 4. In Other Words…Trust, but verify is a form of advice given which recommends that while a source of information mightbe considered reliable, one should perform additional research to verify that such information isaccurate, or trustworthy. The term was a signature phrase adopted and made famous by U.S. presidentRonald Reagan. Reagan frequently used it when discussing U.S. relations with the Soviet Union. SHM PowerPoint Template Guidelines - October 2012
  5. 5. So - What If the Cold Chain Could:• Reduce loss due to temperature excursions by identifying and preventing them before they occur • Measure and track Time Out of Refrigeration• Ensure the efficacy and quality of the product at delivery • Capture and document entire product history• Monitorand manage the temperature of the product without opening or unpacking the shipping container • Identify potential excursions along the way before they occur • Check quality data before accepting receipt of goods • Automatically collect receiving data, to improve compliance reporting and integrity SHM PowerPoint Template Guidelines - October 2012 5
  6. 6. The Next Generation of RFIDISO “Class 3” Battery Assisted Passive RFID Temperature Monitors • Provides access to actionable data on-demand at waypoints • Delivers the ability to read through containers without opening/tampering • Store up to 60K of data with secure access • Monitor cold chain products in an economical and cost effect manner • FAA compliant for use on all aircraft• Manage your cold chain logistics as opposed to just monitoring the results! SHM PowerPoint Template Guidelines - October 2012 6
  7. 7. Key Benefit: On-Demand Data Visibility I’m 2 C I’m 2 C ?°CPassive RFID Wired and Active Tags XC3 Technology (Class 3)• Can’t read the temperature • Requires unpacking/opening the • Know the temperature on-demand without opening the box box • Read at any point in-transit• Once opened, was it tampered • Once opened, was it tampered • No need to unpack or tamper with the with? with? container• Disrupts cold chain operations • Too expensive for 100% • Re-usable, priced for 100% deployment deployment and verification and verification • Active (beaconing) tags can’t be • FAA compliant – doesn’t transmit used on planes SHM PowerPoint Template Guidelines 03.15.10 - October 2012 7
  8. 8. Managing Versus Monitoring I’m I’m I’m 10 C 4 C 8 C 11/5 10:00 4 11/5 10:15 5 11/5 10:30 6 11/5 10:45 8 11/5 11:00 10 11/5 11:15 11 11/5 11:30 12 11/5 11:45 11 11/5 12:00 10Manufacturers, shippers, dispensers have a data record that: • Helps ensure efficacy and quality • Improves cold chain operations • Provides accountability – helps reduce risk by providing supply chain visibility/controlOn-board tag memory stores ePedigree, customs and import/export dataAchieve Supply Chain Visibility Excellence in three key areas: • Reduce time out of refrigeration to save more product • Improved ROI/compliance with a more efficient release to client approval process • Provide better management of reverse logistics SHM PowerPoint Template Guidelines - October 2012 8
  9. 9. 1st Value Point: Controlling Time Out of RefrigerationA major US-based and global drug manufacturer that moves coldchain products between warehouses locally and globally• Issue: Temperature sensitive products are left out, unmonitored, for extended periods of time• Requirements: • A need to obtain true and “on-demand” Time Out of Refrigeration data • The ability to set way points at defined locations to check internal packaging temperatures in an “on-demand” mode ? SHM PowerPoint Template Guidelines - October 2012 9
  10. 10. The SolutionData captured is: Danger Will Robinson! Product• Supplied to their enterprise app’s to determine what is about to have an immediate corrective action needs to be taken, if any excursion!• Used in this mode to audit supply routes and transporters “along the route” for deficienciesImprovements are:• Proactive alerting• Data from the monitoring devices is used as a “real-time” decision source for corrective actions• Data captured determines corrective actions to manage the product movement processes• Loss of products due to out of temperature range excursions is curtailed SHM PowerPoint Template Guidelines - October 2012 10
  11. 11. 2nd Value Point: Extending Visibility Beyond the EnterpriseA major logistics services provider and 3PL with 2 major US hubsand multiple off-shore partners: • Issue: Need to automate receiving compliance • Requirements: • The need to improve efficiencies by on-demand checking for excursions immediately upon arrival of shipped products • Avoidance of relying upon a USB or external cable to connect to the monitoring device • Avoid disturbing the security tape or packaging to retrieve the monitoring device’s data SHM PowerPoint Template Guidelines - October 2012 11
  12. 12. The Solution Automated Information: • Obtain an instant record of the journey temperature stats to check if there were any excursions • Send an instant email of retrieved data to end client and get instant approval for release to their end user Improvements Are: • Improved efficiencies • Cost savings in time to release products on hand • Improved time to revenue • Improved responsiveness to client’s needs • Speeds medications to patients • Management of the data –not just monitoring of the results! SHM PowerPoint Template Guidelines - October 2012 12
  13. 13. 3rd Value Point: Reverse LogisticsA large wholesaler based in the Southern US and a major BostonHospital Pharmacy• Issue: need to manage Reverse Logistics (returned for credit or for stock goods) to improve efficiency and safety and reduce losses• Requirements: • When accepting returned cold chain products for PHARMA credit, or for return to central stock, they need to be assured that temperature and protocol requirements have been maintained • Need a cost effective temperature logging device that can track confirm the maintained condition of the products. SHM PowerPoint Template Guidelines - October 2012 13
  14. 14. The SolutionBetter Control and Management• When received, data is checked to see if temperature profile was maintained. If not, case credit can be justifiably denied (with evidence as to why)• With goods returned from the ward to the pharmacy, it can be confirmed if drugs were keep in a controlled environment and can be returned to controlled stockImprovements are:• Credits can justifiably be given − or refused − with data to back-up the decision• Drugs returned to stock are assured as good and reusable• Destruction of high value drugs due to unknown state of efficacy is eliminated• Patient safety is improved SHM PowerPoint Template Guidelines - October 2012 14
  15. 15. Are these Companies Managing or Just Monitoring their Cold Chain Logistics? Common Themes from the Client Cases: • Data from the data logging devices is not used purely to monitor events or occurrences • Data is available on demand at any point where it is needed as part of the decision making process • Don’t wait until the end of the journey to get an update Benefits: • Reduction of losses by knowing potential excursions or problems before they occur • Compliance benefits for having audit data upon demand • Improved patient safety relative to returned stock • Improved control of high value drugs • Improved visibility into what is going on in the Supply Chain  Therefore: Managing – Not just Monitoring – Their Cold Chain Logistics Operation SHM PowerPoint Template Guidelines - October 2012 15
  16. 16. Two Other ThingsULDs/Active Refrigeration Systems don’t fit in 737sRFID proven to be safe with biologics SHM PowerPoint Template Guidelines - October 2012
  17. 17. Take AwaysThe landscape is changing…dramaticallyNew approaches and techniques will be required to ensure thequality and efficacy of biologicsControlling all of the variables – tricky and high riskIt’s critical to manage – not just monitor – your cold chainRFID (Class 3) is a part of the solution – for a variety of use cases Cold Chain ≠ SHM PowerPoint Template Guidelines - October 2012