Transcript Session-9-ODonnell-and

A Blizzard in the Forecast?
The Changing Face of Regulations, Air Cargo
Transport, and Logistics Driving Global Healthcare
Distribution
Kevin O’Donnell,
Tony Wright,
Director and Chief Technical Advisor,
ThermoSafe Brands and Chair
IATA Time & Temperature Task Force
CEO, Exelsius Cold Chain Management
and member IATA Time & Temperature
Task Force and PCCIG
HPCLC
Long Boat Key, FL 14 October 2010
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
4
2-25C
2
2-8 C
5
2-25 C
3
-30 C
1
2-8 C
Courtesy:
Exelsius/Zymogenetics
Market Statistics
• Market worth approximately US$680bn.
• Temperature-controlled market $168bn.
• Healthcare market forecast to grow to
US$900bn by 2012.
• Nearly 100% of all vaccines and 65% of
biotech products need temperature controlled
storage and transportation.
• Biotech market fastest growth – majority by
air cargo.
Air Cargo’s Changing Airscape
• Downsized Fleets
• Reconfigured Aircraft Utilization
• Airline Consolidation
• Abandon Lanes
• Trade Imbalances
The 2010 Turnaround
Air Freight Capacity is not Keeping up
with Global Growth.
Source: Boeing Report, June 2010
New Aircraft Orders are Up
Source: Boeing Report, June 2010
Aircraft Demand by size 2009-2029
Size
Source: Boeing Report, June 2010
New
Airplanes
Value ($B)
Regional
Jets
1,920
60
Single Aisle
21,160
1,680
Twin Aisle
7,100
1,630
Large
720
220
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
Total
Airline Revenues
US$50bn
Source: :IATA
• 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.
‘Cold Chain’ Products Growing
Faster
Global Biopharma Sales 2008-2011
$877bn
$ Billions
$773bn
Total Market
+13%
$187bn
$147bn
Source: Pharmaceutical Commerce
Cold Chain
Products +27%
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 in the air cargo
logistics process – who’s involved?
Manufacturers
& Shippers
Thermal Solution
Providers
Origin
Forwarders
&
Trucking
Co’s.
Airport
Ground
Handlers
Origin-Destination
Air Carrier
Airport
Ground
Handlers
Destination
Forwarders &
Trucking Co’s
Collaboration: Getting the entire cold chain
working together to improve the way it operates
Distributors &
Consignees
Key Areas of Cold Chain Risk
23%
57%
20%
Manufacturers
& Shippers
Thermal Solution
Providers
Origin
Forwarders
&
Trucking
Co’s.
Airport
Ground
Handlers
Origin-Destination
Air Carrier
Airport
Ground
Handlers
Distributors &
Consignees
Destination
Forwarders &
Trucking Co’s
Courtesy Exelsius
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!
Thank You!
Tony Wright
[email protected]
Kevin O’Donnell
kevin.o’[email protected]