Steven Effler, Susan O’Donnell, David Matthews, Carol Matthews, David O’Donnell,
A Blizzard in the Forecast? The Changing Face of Regulations, Air Cargo Transport, and Logistics...
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Transcript of A Blizzard in the Forecast? The Changing Face of Regulations, Air Cargo Transport, and Logistics...
A Blizzard in the Forecast?
The Changing Face of Regulations, Air Cargo Transport, and Logistics Driving Global Healthcare
Distribution
Kevin O’Donnell, Director and Chief Technical Advisor, ThermoSafe Brands and ChairIATA Time & Temperature Task Force
HPCLC Long Boat Key, FL 14 October 2010
Tony Wright, CEO, Exelsius Cold Chain Managementand member IATA Time & Temperature Task Force and PCCIG
Regulatory Drivers
• Increased scrutiny on the entire distribution supply chain
• Increased expectation in shipment monitoring• Greater regulatory enforcement
Major Regulatory Changes, Standards & Guidance to be enacted in 2011
• United States Pharmacopoeia– General Chapter <1079> Good Storage and Shipping
Practices
• World Health Organization– Harmonized guidance for the storage and transport of
time and temperature–sensitive pharmaceutical products
• Health Canada’s – GUIDE-0069 Guidelines for Temperature Control of Drug
Products during Storage and Transportation
But Wait – There’s More!
• Parenteral Drug Association– Technical Report No. 39: Guidance for
Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
– Technical Report No. 46: Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User
… and more
– PDA Technical Report No ?: Recommended Best Practices for Manufacturers of Temperature Sensitive Products to Comply with TSA Cargo Screening Requirements
– HDMA Managing Cold Chain & Temperature Sensitive Products
– IATA Chapter 17: Air Transport Logistics for Time and Temperature-Sensitive Healthcare Products
– And more on the way!
Why All the Attention?
• Substantial increase in temperature-controlled drug products due to:
– Patent expiration on biological drugs– Surge in biologics– New product development– New global markets– Evolving manufacturing practices
Global Manufacturing Processes
12-8 C
42-25C
3-30 C
22-8 C
52-25 C
Courtesy:Exelsius/Zymogenetics
Market Statistics
• Market worth approximately US$680bn.• Temperature-controlled market $168bn.• Healthcare market forecast to grow to
US$900bn by 2012.• Nearly 100% of all vaccines and 65% of
biotech products need temperature controlled storage and transportation.
• Biotech market fastest growth – majority by air cargo.
Air Cargo’s Changing Airscape
• Downsized Fleets
• Reconfigured Aircraft Utilization
• Airline Consolidation
• Abandon Lanes
• Trade Imbalances
The 2010 Turnaround
Air Freight Capacity is not Keeping up with Global Growth.
Source: Boeing Report, June 2010
New Aircraft Orders are Up
Source: Boeing Report, June 2010
Aircraft Demand by size 2009-2029
Size New Airplanes Value ($B)
RegionalJets 1,920 60
Single Aisle 21,160 1,680
Twin Aisle 7,100 1,630
Large 720 220
Source: Boeing Report, June 2010
Emerging economies and changing demographics will shift passenger traffic and consequently, cargo flows
And at a time when outsourced production means greater logistical challenges to cold chain distribution……
The Overall Air Cargo Sector • Approximately 12% of total airline revenues are from air cargo.
• By volume of cargo carried, only 5% is ‘perishable’.
• Healthcare products represent less than 0.5% of total air cargo.
Total Airline Revenues
US$50bn
Source: :IATA
‘Cold Chain’ Products Growing Faster
Cold ChainProducts +27%
$773bn
$187bn
$147bn
$877bn Total Market +13%
Global Biopharma Sales 2008-2011
Source: Pharmaceutical Commerce
How is the global air cargo sector reacting?
• Increased focus on the healthcare sector.
• Increased collaboration.
• New air cargo handling regulations.
• Improved technology.
Increased Sector Focus
# Global Airlines offering Pharmaceutical ‘cold-chain’ products
Collaboration
• Mutual
• Physical
• Beneficial
Collaboration: Getting the entire cold chain working together to improve the way it operates
Collaboration in the air cargo logistics process – who’s involved?
Distributors &Consignees
OriginForwarder
s & Trucking
Co’s.
Origin-Destination Air Carrier
DestinationForwarders &Trucking Co’s
Manufacturers& Shippers
AirportGround
Handlers
Thermal SolutionProviders
AirportGround
Handlers
Distributors &Consignees
OriginForwarder
s & Trucking
Co’s.
Origin-Destination Air Carrier
DestinationForwarders &Trucking Co’s
Manufacturers& Shippers
AirportGround
Handlers
Thermal SolutionProviders
AirportGround
Handlers
23% 57% 20%
Courtesy Exelsius
Key Areas of Cold Chain Risk
Collaboration in Practice
• IATA Time & Temperature Task Force
• Manufacturers, forwarders, airlines, regulators, ground handling co’s, technology providers, etc
• Brought together into a commonly understood purpose – patient safety.
• Required immense time & effort
Collaboration resulted in a new set of Regulations...
• IATA Perishable Cargo Regulations, Chapter 17
• Binding to all IATA members
• Specific to the handling of time and temperature-sensitive products.
... and a vital new label
Gaining Industry Support
Courtesy CSafe & ThermoSafe
Transportation Technology Advances
• Provides both heating and cooling.
• Reliable, compressor-driven technology.
• On-board temperature monitor
Summary
• Regulation, regulation, regulation• Challenges of global manufacturing• Air Cargo’s changing ‘airscape’• Capacity vs. growth• Cold chain growing fast(er)• The air cargo sector is reacting• Collaboration & new technology
Who depends on us working together?
They Do!