Transcript A Blizzard in the Forecast?
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 Chair IATA Time & Temperature Task Force Tony Wright, 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
– – HDMA Managing Cold Chain & Temperature Sensitive
Products
– PDA Technical Report No ?: Recommended Best Practices
for Manufacturers of Temperature Sensitive Products to Comply with TSA Cargo Screening Requirements
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
5
2-25 C
4
2-25 C
2
2-8 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$900bn by 2012.
Nearly 100% of all vaccines and 65% of biotech products need temperature controlled storage and transportation.
Biotech market fastest growth – majority by air cargo.
Air Cargo’s Changing Airscape
• Downsized Fleets • Reconfigured Aircraft Utilization • Airline Consolidation • Abandon Lanes • Trade Imbalances
The 2010 Turnaround
Air Freight Capacity is not Keeping up with Global Growth.
Source: Boeing Report, June 2010
New Aircraft Orders are Up
Source: Boeing Report, June 2010
Aircraft Demand by size 2009-2029
Size Regional Jets Single Aisle Twin Aisle Large New Airplanes Value ($B)
1,920 21,160 7,100 720 60 1,680 1,630 220 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……
Source: :IATA
The Overall Air Cargo Sector
Total Airline Revenues • Approximately 12% of total airline revenues are from air cargo.
US$50bn • 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 Total Market +13% $773bn $147bn Source: Pharmaceutical Commerce $187bn
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
• Mutual • Physical • Beneficial Collaboration
Collaboration in the air cargo logistics process – who’s involved?
Manufacturers & Shippers Thermal Solution Providers Origin-Destination Air Carrier Origin Forwarders & Trucking Co’s.
Airport Ground Handlers 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 20% 23%
Manufacturers & Shippers Thermal Solution Providers Origin Forwarders & Trucking Co’s.
Airport Ground Handlers
57%
Origin-Destination Air Carrier Airport Ground Handlers Destination Forwarders & Trucking Co’s Distributors & Consignees
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]