Your SlideShare is downloading. ×
0
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Cold Chain Shipping Innovations: Keys to Maintaining Specimen Integrity Larry Stambaugh, Chairman and Chief Executive Officer Cryoport

810

Published on

Overview …

Overview
In many clinical trial scenarios, there may only be one chance to collect, ship, test and analyze a patient's specimen. These often time-sensitive snapshots into a patient's progression in a study are critical not only to the overall study results, but ultimately the safety of patients undergoing treatment.

The lifecycle of a specimen, which starts at collection and ends at database lock, can be prone to human error along each step of the testing process, particularly when conducting global clinical trials in more remote ends of the world. Sponsors need to ensure the integrity of the specimen throughout this process, while balancing the relative cost of logistics.

Based on lessons learned from managing global clinical trials testing, ACM Global Lab and its partners will share their insights on monitoring and oversight on patient safety, safeguarding sample integrity, and good business sense.

Published in: Health & Medicine, Business
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
810
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. 1
  • 2. An Innovative Approach to Handling Cold Chain Clinical Trial Material in the Transportation Channels Larry G. Stambaugh Chairman & CEO CryoPort, Inc. 2
  • 3. Today – Frozen Shipping for the New Global Requirements in Clinical Trial Specimens• Frozen shipping is dominated by dry ice and the paradigms established by its limitations• Specialty couriers have been widely used to globally transport dry ice• Freight forwarders have not been willing to provide re- icing services• Most trials have been run in the U.S. and Western Europe• Biologicals have played a smaller role in products and drug development in the past• Moving products and samples has gotten more difficult in today’s new norm for global 3
  • 4. New Forces Working on Global Cold Chain • Globalization of products and clinical trial markets are stretching the current standard options and raising new concerns • Growing regulatory concern about proving cold chain integrity and security• More biologicals in development today than ever before• Emphasis on improving security and sustainability in cold chain processes 4
  • 5. Globalization of transportation of frozen biologicals and products There are 110,965 clinical trials listed in 174 countries today * As of July 2011 the global trials breakdown as follows:* • United States 55,548 • Western Europe 28,408 • China 8,352 } • Canada 8,471 • Latin America 6,522 • Southeast Asia / Australia 5,238 • Middle East 41,008 4,318 • Africa 2,381 • Japan 1,917 • Eastern Europe 1,920 • India 1,889*clinicaltrials.gov 5
  • 6. Explosive Growth in Cold Chain Segment of Clinical TrialsGrowth projected 2012 - 2015 in cold chain* – US 15% – Europe 18% – Asia 43% – Rest of world 59% (Brazil, Eastern Europe, Middle East)*Biopharma cold chain Sourcebook 2011 6
  • 7. Significant Trends in Pharmaceutical Development• More biologicals in development today than ever before – more than 400 *• Of 15 drug approvals in the U.S. for new molecular entities during 2010, 11 were biologicals**• Unprecedented trend toward outsource clinical development to CROs, Central Labs and others• First time that regulatory approvals of new drugs in Europe exceeded the U.S.• Companies starting to look at first approvals in China and Middle East*BioPharma Cold Chain Source Book** Pharma.org – new drug approvals in 2010 7
  • 8. More Challenges for Frozen Shipping• Increase in stem cells, cell lines, cell banks, in-vitro fertilization, vaccines, etc. Biologists report up to 40% loss of cells during transportation• High value and volatile biologicals Values can range from $1,000 to $5,000 for many of the biological shipments today• Pressure on costs of product distribution and clinical development Overnight shipping expensive and increased global shipping is raising costs• Data monitoring needed to prove integrity and security Temperature excursions hard on biologicals Constant track and trace often ineffective today Regulatory scrutiny of temperatures a new focus 8
  • 9. The New Norm• Terrorists alerts and grounded planes• Volcano disruptions• Suspicious packages delays• Custom increased scrutiny• Sophisticated counterfeiting of drug products• Changing regulations and permits required• More limited routes by carriers• Limiting dry ice volume per plane• Outsourcing of non core processes required 9
  • 10. The Future of Frozen Shipping for theNew Global Requirements in Clinical Trial Materials and Pharmaceutical Products Longer holding times for packaging alternatives and new technologies needed for global shipments: Dry Ice sublimates daily – requires specialty carriers LN2 dry vapor provides longer holding times up to 10+ days Gel Packs and phase change materials provide longer holding times 10
  • 11. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products, cont.Stable temperatures, eliminating temperature excursions arenecessary for most biologicalsDry ice (-70 C) fluctuates with re-icing and other conditionsLN2 dry vapor provides a stable constant temperature(-150 C - below the glass point)Phase change materials provide variable temperature ranges 11
  • 12. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products, cont.Temperature monitoring that verifies integrity and security ofsamples and productsSpecimen or product temperature monitoring is difficult with dryice – probes used to monitor box not samplesSpecimen chamber temperature monitoring is possible with LN2dry vapor and some phase change materials 12
  • 13. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products, cont.Temperature monitoring that verifies integrity and security ofsamples and products, continuedData monitors generally track temperature onlyNew monitors will track:• Temperature• Humidity• Shock and vibration• PressureMonitors may be used to manage security by detecting tamperingduring shipment. 13
  • 14. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products, cont.Shipping solutions will better utilize “green” sustainablematerials and processesDry Ice is considered dangerous goods shipping and it is shipped inStyrofoam / EPS boxes that are excluded from landfillsNew technologies such as LN2 dry vapor and phase changematerials introduce non hazardous shipping and recyclablematerials 14
  • 15. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products, cont.Business models that facilitate full outsourcing of the frozenshipping solution desirableSolutions that provide outsourced capabilities to manage frozenshipping in connection with Good Distribution ProcessesExpertise in complying with country by country rapidly changingcustom and permit requirements in global shipping 15
  • 16. Other Possibilities Through Innovation Rethinking Frozen Supply Chain• Shipping products and collecting clinical samples five days a week• Two day shipping rather than overnight• Using shipping container as temporary storage device• Wireless temperature monitoring• More cost effective outsourcing of cold chain transportation• Eliminate risk of loss of sample viability due to degradation 16
  • 17. The Future of Frozen Shipping for the New Global Requirements in Clinical Trial Materials and Pharmaceutical Products• Longer holding times for packaging alternatives• Stable temperatures, eliminating temperature excursions• Improved processes to address customs, permits and increasing regulations• Temperature and data monitoring that verifies integrity and security of samples and products• Compliance with good distribution practices by outsourced partners• Sustainable processes that eliminate hazardous materials and non recyclable materials• Shipping five days a week and two day shipping• Cost effective outsourcing of shipping process 17
  • 18. CryoPort Express® – Setting a New StandardEnter order through CryoPort’s CryoPort Express® proprietary Package received andExpress® Portal which manages container arrives ready to ship unloaded; simply flip box flaps,complexities of all required legs with all required docs and no and send to CryoPort for reuse of transit hazmat handling Preparation In-Transit Post-Shipment Technology-rich web portal  10 day holding time allows much greater  Data logger tracks temperature streamlines ordering and flexibility and no re-icing throughout shipment, ensuring integrity ensures successful shipment  Stable -150 degree celsius ensures of sample and detection of tampering Easy to use dry vapor LN2 condition of specimen throughout transit  Simply return shipper to CryoPort - no shipper arrives charged with  Integrated carrier solution allows for environmentally unfriendly packaging to required documentation greater control of shipment progress dispose of Non-hazardous shipping and – In transit updates and alerts available  CryoPort dry vapor LN2 shipper is tested, handling through portal and sterilized for next shipping cycle  Reliable, outsources frozen shipping solution CryoPort’s Express® Offers a Simpler Method with More Reliability for Less Cost 18
  • 19. Questions? Thank you• Larry G. Stambaugh• Chairman & CEO• CryoPort, Inc.

×