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Tuesday, January 5

Where in the World?...
by
Kevin O'Donnell
on Tue 05 Jan 2010 03:25 PM CST
The following is a running list (newest to oldest) of conferences, meetings, round tables, webinars, trade shows, and related cold-chain events where I will be making a presentation or participating. Links provided.
I hope to see you there!
April 20-22, 2010
International Air Transport Association (IATA)
Live Animals & Perishables Board (LAPB) Meeting
Continental Airlines, Houston, TX
Time and Temperature Task Force Semi-Annual Meeting
______________________
April 12-13, 2010
2010 PDA Pharmaceutical Cold Chain Management Conference
Hyatt Regency, Bethesda, Md
Conference brochure: http://www.pda.org/swf/cold-chain-cat/index.html
___________________
March 8-11, 2010
IATA World Cargo Symposium
Sheraton Vancouver Wall Center, Vancouver, Canada
Plenary Chairperson Time & Temperature Track Feb 9-10
Conference brochure: http://www.iata.org/NR/rdonlyres/6405EF85-D7C6-455B-B72D-BF31AF1D50E6/0/TimeandTemperature.pdf
_______________________
February 23-25, 2010
8th Cold Chain Management & Temperature Control Summit
Westin Harbour Castle, Toronto, ON, Canada
Plenary Chairperson (Jan. 28th) &
Panel Discussion: Complying with IATA Chapter 17 Revised Regulations & Biopharma Requirements for Temperature Sensitive Products
Conference brochure: http://image.exct.net/lib/ff2b12797165/d/1/Cold%20Chain%20Canada%202010.pdf
_______________________
January 26-28, 2010
9th Annual IQPC Cool Chain Europe
Okura Hotel, Amsterdam, Netherlands
Plenary Chairperson (Jan. 28th)
Presentation: Update on the Application of Revised Chapter 17 IATA Guidelines
____________________
December 8-9, 2009
IQPC Clinical Trials Logistics Conference
Ritz-Carlton Hotel, Philadelphia, PA
____________________
December 3-4, 2009
World Health Organization
Consultative Meeting With Industry
WHO Headquarters, Geneva, Swizerland
Co-Chair: Performance, Quality and Safety Meeting
_________________________
October 28-29, 2009
Panalpina Logistics Conference
Huntsville, Alabama
___________________________
October 20-21, 2009
International Air Transport Association (IATA)
Live Animals & Perishables Board (LAPB) Meeting
IATA Headquarters, Montreal, Ontario, Canada
Time and Temperature Task Force Semi-Annual Meeting
_____________________
October 6-7, 2009
2009 PDA Conference on Cold Chain Management:
From Suppliers to Customers
Berlin Hilton Hotel,
Berlin, Germany
Presentation: (Oct. 6th), Changes in the Air: The Impact of the New IATA Regulations on the Distribution of Time- and Temperature Healthcare Products
_________________________________
October 2nd, 2009
PARCS (Pacific Region Clinical Supplies) Fall Conference
Embassy Suites Hotel,
South San Francisco, California
Moderator: Current Aspects of Shipping, Security, Storage, and Monitoring of Temperature Sensitive Investigational Drug Products
_______________________
September 22-24, 2009
USP Annual Scientific Meeting 2009 - North America
Sheraton Centre Toronto Hotel,
Toronto, Ontario, Canada
Presentation: (Sept. 24th), Air Transport Logistics for Time & Tempeature-Sensitive Healthcare Products: Meeting the Requirements of the New International air Tranport Association Regulations
_______________________
September 21st - 24th, 2009
IQPC 7th Annual Global Forum Cold Chain Distribution for Pharmaceuticals
Philadelphia Convention Center
Plenary Chaiperson for Transportation and Logistics Section (Sept. 23rd)
____________________
June 2-3-4, 2009
9th DHL Global Forwarding Life Sciences and Healthcare Global Conference
InterContinental Miami Hotel
_________________
May 13, 2009
Midwest Healthcare Supply Chain Conference
University Place Conference Center, Indianapolis, Indiana
Presented by the Indiana Health Industry Forum & The Indianapolis Airport Authority
Global Trade & Logistics Panel Discussion
_______________
April 24, 2009
Pacific Region Clinical Supplies (PARCS) Spring Meeting
Westgate Hotel, San Diego, CA
Presentation: "Regulatory & Best Practices Impacting Temperature Controlled Shipments"
Workshop: "Wading through the new Airline Logistics Regulations"
__________________
April 20-21-22, 2009
PDA Annual Meeting
Las Vegas, NV
Presentation: (4/22) "Advancing Thermal Package Design
by Combining Modern Technologies"
___________________
March 31, 2009
Health & Personal Care Logistics Spring Conference
Philadelphia, PA
Presentation: "Packaging Validation in Distribution"
__________________
March 23-24, 2009
2009 PDA Pharmaceutical Cold Chain Management Conference
Hyatt Regency, Bethesda, Md
Presentation: "Changes in the Air"
The influences of TSA cargo security mandates, an overview of the Certified Cargo Screening Facility program, analysis of airline industry consolidation, lithium batteries Special Provisions Dangerous Goods requirements, and an overview of IATA's new Perishables Cargo Regulations Chapter 17, affecting and impacting time-and temperature sensitive healthcare products.
________________
March 18, 2009
International Air Transport Association (IATA)
Live Animals & Perishables Board (LAPB) Meeting
The LAPB will conduct a one day meeting to review, discuss, and vote on whether to accept the various recommendations of the Time & Temperature Task Force including revisions to the Perishable Cargo Regulations Chapter 17, Air Transport Logistics for Time- and Temperature Sensitive Healthcare Products, guidance on a Quality Management System, and recommnedations for a universal time- and temperature sensitive handling label.
Wednesday, May 20

There's More to Indianapolis in May Than the "500"
by
Kevin O'Donnell
on Wed 20 May 2009 10:32 AM CDT
The Indianapolis Airport Authority in league with the Indiana Health Industry Forum must be exhausted after concluding their inaugural Midwest Healthcare Supply Chain Conference on May 13th. The well orchestrated event was by any and all measures, a huge success among the 136 delegates in attendance - not bad in this economy.
The purpose of the conference was to unite the Midwest’s experts in healthcare logistics, distribution and manufacturing and to examine industry trends, challenges and best practices five to ten years down the supply chain road.
The targeted audience were executives throughout the healthcare value chain with the goal to showcase the advantages of the Indianapolis area and more specifically, the "New and Improved" Indianapolis International Airport (IND), as a viable alternative for centralizing Midwest distribution of time- and temperature-sensitive healthcare products, and to nurture an understanding throughout the distribution chain of Indiana’s long range plan for providing the infrastructure necessary to accommodate the growing healthcare industry.

The New $1.1 Billion Indianapolis International Airport
Terminal and 8th largest Cargo Facility in the US
The proceedings were well organized, well attended, and well received in what has been by-and-large an underserved market for cold-chain conferences. The unique aspect of this cold-chain event was that it focused on long range planning (LRP) and the presentations were themed on what the landscape of the healthcare supply chain might look like in 2015-2020.
The event was low cost (about $350), one day, and within driving distance for most Midwest attendees. About 60% of the delegates were not drug manufacturers or innovators, but 3PL and other service providers. Since the conference was held on the beautiful, spacious, and ridiculously accessible Indianapolis campus of Indiana University & Purdue University (IUPUI), there were a number of members from academia as well, both students and professors.
Presenters were not those typically associated with other cold-chain events. The keynote address was delivered by Dr. Yossi Sheffi, Director, MIT Engineering Systems Center for Transportation and Logistics, who highlighted potential supply chain vulnerabilities resulting from acts of God, terrorism, and political upheaval, and how and what companies must do to prepare for such eventualities, as well as site several case studies where supply chain interruption have caused companies (such as Erickson phones) to fail.
A compelling argument was made by Dr. Mahender Singh, Research Director for the MIT Supply Chain 2020 Research Project & Efficient Healthcare Delivery Project, that emphasized the future evolution of healthcare in America – moving from an acute care to largely a chronic care process as the population ages and personalized medicine and technology advance. The impact this evolution will have on the current methodologies for supply chain were surprising and clearly demonstrated.
The following session was attended by my colleague, Susan Li, who offered these take-aways from the forward-thinking presentation, Demand Driven Supply Networks in Healthcare, by Hussain Mooraj, VP of Healthcare & Life Science, AMR Research -
· In healthcare industry, traditional supply chains were designed and operated with inside-out thinking. All supply chain and operations processes—from planning, sourcing, manufacturing, and distribution—were designed without considering the needs of upstream and downstream trading partners, let alone the patient. Manufacturers have long planned their operations based on factory capacity and asset utilization.
· Some leading companies are taking a new view: allowing customer demand to drive supply chain planning and execution. This approach – demand driven supply network, uses a system of technologies and processes to sense demand and react to it in real time, across a network of linked customers, suppliers, and employees. The financial results can be dramatic. In a recent study by AMR research, companies that excel at demand forecasting have 15% less inventory, 17% stronger order fulfillment, and 35% shorter case-to-cash cycle time than typical companies.
· The first step in making a successful transition to demand-driven supply chain practices is to develop corporate supply-chain strategies at executive level. Establishing a sales and operational planning (S&OP) team that meets frequently to share this information can help a company integrate the planning of production, procurement, logistics and sales information. The challenge in this step is gathering accurate customer demand information in healthcare industry is very difficult.
· The second step is to understand or create cross functional best practices that frequently review and assess production against demand. Companies must design operational and supply chain processes from the inside-out to ensure quality and compliance, and minimize the time and resources required to deliver products “right first time”.
The most interesting and entertaining presentation was the keynote luncheon address by Dr. Adam Fein, founder and president of Pembroke Consulting.

"Dr. Howard, Dr. Fein, Dr. Howard!"
His thirty minute, no-nonsense statistics and opinions on healthcare distribution security and patient safety, poignantly illustrated the breadth, and scope of secondary channel drug distribution which often results in diversion and counterfeit. Also, how State’s Boards of Pharmacy are doing little to change the many serious flaws in the drug distribution system. Dr. Fein also blogs at Drug Channels, with views on pharmacy economics and pharmaceutical supply chain.
I participated as a panel member among experts who discussed the critical elements and practices involved in designing and operating in U.S. and global distribution channels related to meeting expected regulatory compliance within the framework of service supplier capabilities and adapting to in-country infrastructure inequities without compromising drug product quality.
Overall, it was a very satisfying and educational day. The Indianapolis Airport Authority and the Indiana Health Industry Forum are already planning on an encore conference, tentatively set for next May. Stay tuned.

At the Finish Line,
Indianapolis Motor Speedway
Wednesday, March 4

Where in the World?...
by
Kevin O'Donnell
on Wed 04 Mar 2009 11:18 AM CST
The following is a running list of conferences, meetings, round tables, webinars, trade shows, and related cold-chain events where I will making a presentation. Links provided. I hope to see you there!
March 18, 2009
International Air Transport Association (IATA)
Live Animals & Perishables Board (LAPB) Meeting
The LAPB will conduct a one day meeting to review, discuss, and vote on whether to accept the various recommendations of the Time & Temperature Task Force including revisions to the Perishable Cargo Regulations Chapter 17, Air Transport Logistics for Time- and Temperature Sensitive Healthcare Products, guidance on a Quality Management System, and recommnedations for a universal time- and temperature sensitive handling label.
March 23-24, 2009
2009 PDA Pharmaceutical Cold Chain Management Conference
Hyatt Regency, Bethesda, Md
Presentation: "Changes in the Air"
The influences of TSA cargo security mandates, an overview of the Certified Cargo Screening Facility program, analysis of airline industry consolidation, lithium batteries Special Provisions Dangerous Goods requirements, and an overview of IATA's new Perishables Cargo Regulations Chapter 17, affecting and impacting time-and temperature sensitive healthcare products.
March 31, 2009
Health & Personal Care Logistics Spring Conference
Philadelphia, PA
Presentation: "Packaging Validation in Distribution"
April 20-21-22, 2009
PDA Annual Meeting
Las Vegas, NV
(Presentation 4/22)
"Advancing Thermal Package Design
by Combining Modern Technologies"
April 24, 2009
Pacific Region Clinical Supplies (PARCS) Spring Meeting
Westgate Hotel, San Diego, CA
Presentation: "Regulatory & Best Practices Impacting Temperature Controlled Shipments"
Workshop: "Wading through the new Airline Logistics Regulations"
May 13, 2009
Midwest Healthcare Supply Chain Conference
University Place Conference Center, Indianapolis, Indiana
Presented by the Indiana Health Industry Forum & The Indianapolis airport Authority
Global Trade & Logistics Panel Discussion
June 2-3-4, 2009
9th DHL Global Forwarding Life Sciences and Healthcare Global Conference
InterContinental Miami Hotel
Thursday, October 2

Regulatory Updates, Track & Trace Management, and a New Generation of Insulated Sea Containers are Topics of Greatest Interest at IQPC Cold Chain Distribution Conference
by
Kevin O'Donnell
on Thu 02 Oct 2008 12:23 PM CDT
The 6th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference was held
September 22-25, 2008, at the Philadelphia Convention Center, Philadelphia, PA. More than 300 delegates and 34 exhibitors participated.
Presentation topics were focused on logistics with an emphasis on international transport, clinical trials and the "last mile" of distribution. It was slightly more technical with less overt selling than in years past and there was no shortage of panel discussions and roundtables in addition to only a few case history presentations. The event reflected the maturing of this segment of distribution as both presenters and audience were far more knowledgeable than in the past.
The conference began with regulatory speakers from the UK and Canada providing updates to activities in their respective agencies. They concur that temperature monitoring will be viewed as a must-have, or a “critical component” to good distribution practices for time and temperature sensitive healthcare freight. Harold Rode of Health Canada was completely non-committal when pressed about when the agency is going to publish the revised edition of guide 0069 (currently under review).
Mary Foster of Catalent, and the person responsible for the re-write of USP General Chapter <1079> Good Storage and Shipping Practices, and stated that the new document draft ( 49 pages and more than 3X longer than the current edition) was submitted to the USP Expert Committee on Packaging. It came as a surprise to many in attendance that references to Mean Kinetic Temperature as it relates to transportation were removed by the USP 1079 revision committee and that they strongly recommended to the EC that it remain out of the document.
Other presentations of note: the new TSA 100% cargo screening regulations drew many questions for the presenter, Brad Elrod, Manager Global Logistics & Security, Pfizer, and Jean-Pierre Emond from the University of Florida made a well documented presentation on testing he has done on the new generation of insulated sea containers and whetted the appetite of those considering the possibility of using them as an alternative to air freight. These containers are so well insulated that they hold only 40% of the payload of existing insulated reefers. He cited a reduction in freight costs by 40%. Their use is not without significant risk however, especially during loading and unloading at the port when there is no means to control the logistics or ability to provide AC power to run the refrigeration units. Emond objectively stated that the greatest drawback to this technology is that there are only 30 containers worldwide and the developer is not expected to play “build it and they will come.”
The “sponsors,” or service and supply partners to the industry appeared well organized. There were neary twice as many than at last year's conference (19). There is a definite shift in representation of those exhibiting, with 12 3PL and specialty logistics and transport providers, 10 data management companies and 12 packaging / platform providers.
If this IQPC event is indicative of future events, there appears to be a shift of focus away from is manufacturing and qualifying packaging and transportation - to logistics compliance, documenting control of the transportation process and data management.
Thursday, August 14

PDA Offers Second Chance at Good Cold Chain Managment Training
by
Kevin O'Donnell
on Thu 14 Aug 2008 03:08 PM CDT
For those of you who missed the opportunity in March or were turned away because the class was a sell-out; the Parenteral Drug Association Training and Research Institute (PDA-TRI) is once again offering their two day Cold Chain Management Course, Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging, Testing and Transport Systems in conjunction with its annual PDA/FDA Joint Regulatory Conference.
The Training will take place following the joint conference on September 11-12th 2008. Details can be found here.
The course is only offered twice a year in the US and there are a limited amount of seats available.
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