Good Cold Chain Management Practices for Vaccine Distribution

Sensitech Abstract Proposal Good Cold Chain Management Practices for Vaccine Distribution

Background: The biologic drug market continues to outpace the traditional chemical-based drug market – estimates suggest a $100 - $120 Billion market in 2010, representing an annual grow rate in excess of 10%.  As the growth in the biologic market continues to outpace the traditional chemical-based market – cold chain continues to be an increasingly important component of the global pharmaceutical supply chain.  The growth in the biologic-based drug market has created increased awareness of the global regulatory and standards-based guidance for the storage, handling, and distribution of temperature sensitive medicinal products.  Biologic drugs, including vaccines, are temperature sensitive and require special handling to mitigate the variability often found in later-stages of distribution. 

Setting:This presentation will review the regulatory trends and industry best practices for the storage, handling, and distribution of vaccines.  The presenters will evaluate the use of temperature indicators for the “last mile” of distribution.  The benefits and challenges faced when incorporating temperature indicators into a temperature monitoring program will be explored.  And, the importance of applying a risk-based approach to decrease cold chain variability thus ensuring product quality and patient safety will be explored. 

Population: Vaccine distribution market

Project Description: Evaluation of good cold chain management practices for the storage, handling, and distribution of temperature-sensitive medicinal products. 

Results/Lessons Learned: A thorough review of risk mitigation strategies for cold chain distribution.  Henry Ames, Director of Strategic MarketingHenry Ames joined Sensitech in 2004 as the director of strategic marketing. He focuses on global market analysis and strategic marketing initiatives for the Life Science Vertical. Prior to Sensitech, he was a principal at Megunticook Management, a venture capital firm in Boston with $150 million under management and investments in promising communications, media and technology companies.  While at Megunticook, Ames focused on supply chain-related investments.  Before that he was manager of business development for Yantra, a leading provider of distributed order management and supply chain-fulfillment software.  Ames earned an MBA from the F.W. Olin Graduate School of Business at Babson College, and a double major in Business Management and Entrepreneurship from Florida State University.  Ames also serves as a member of the Board of Overseers of the Beth Israel Deaconess Medical Center in Boston, MA.  Mark Maurice: Senior Project Manager, Industrial EngineerAs the Senior Project Manager for Sensitech’s Life Science division, Mark is responsible for managing a cross functional team of Project and Assistant Project Managers with backgrounds in Industrial Engineering, validation, logistics, and Technical Writing.  Prior to Sensitech, Mark spent sixteen years at United Parcel Service as an Industrial Engineering and Operations Manager.  While at UPS, Mark completed numerous projects focused on supply chain and warehousing improvements.  Mark earned his Masters in Industrial Engineering and Bachelors in Architecture from the University at Buffalo.