Title: A Blizzard in the Forecast? The Changing Face of Regulations, Air Cargo Transport, and Logistics Driving Global Healthcare Distribution
1A Blizzard in the Forecast?The Changing Face
of Regulations, Air Cargo Transport, and
Logistics Driving Global Healthcare Distribution
Tony Wright, CEO, Exelsius Cold Chain
Management and member IATA Time Temperature
Task Force and PCCIG
- Kevin ODonnell,
- Director and Chief Technical Advisor,
- ThermoSafe Brands and Chair
- IATA Time Temperature Task Force
- HPCLC
- Long Boat Key, FL 14 October 2010
2Regulatory Drivers
- Increased scrutiny on the entire distribution
supply chain - Increased expectation in shipment monitoring
- Greater regulatory enforcement
3Major Regulatory Changes, Standards Guidance to
be enacted in 2011
- United States Pharmacopoeia
- General Chapter lt1079gt Good Storage and Shipping
Practices - World Health Organization
- Harmonized guidance for the storage and transport
of time and temperaturesensitive pharmaceutical
products - Health Canadas
- GUIDE-0069 Guidelines for Temperature Control of
Drug Products during Storage and Transportation
4But Wait Theres 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
5 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!
6Why 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
7Global Manufacturing Processes
Courtesy Exelsius/Zymogenetics
8Market Statistics
- Market worth approximately US680bn.
- Temperature-controlled market 168bn.
- Healthcare market forecast to grow to US900bn 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.
9Air Cargos Changing Airscape
- Downsized Fleets
- Reconfigured Aircraft Utilization
- Airline Consolidation
- Abandon Lanes
- Trade Imbalances
10The 2010 Turnaround
11Air Freight Capacity is not Keeping up with
Global Growth.
Source Boeing Report, June 2010
12New Aircraft Orders are Up
Source Boeing Report, June 2010
13Aircraft Demand by size 2009-2029
Size New Airplanes Value (B)
Regional Jets 1,920 60
Single Aisle 21,160 1,680
Twin Aisle 7,100 1,630
Large 720 220
Source Boeing Report, June 2010
14Emerging 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
15The 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.
16Cold Chain Products Growing Faster
Global Biopharma Sales 2008-2011
Source Pharmaceutical Commerce
17How is the global air cargo sector reacting?
- Increased focus on the
- healthcare sector.
- Increased collaboration.
- New air cargo handling
- regulations.
- Improved technology.
18Increased Sector Focus
Global Airlines offering Pharmaceutical
cold-chain products
19Collaboration
- Mutual
- Physical
- Beneficial
20Collaboration in the air cargo logistics process
whos involved?
Collaboration Getting the entire cold chain
working together to improve the way it
operates
21Key Areas of Cold Chain Risk
23
57
20
Courtesy Exelsius
22Collaboration in Practice
- IATA Time Temperature Task Force
- Manufacturers, forwarders, airlines,
- regulators, ground handling cos,
- technology providers, etc
- Brought together into a commonly
- understood purpose patient
- safety.
- Required immense time effort
23Collaboration 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.
24... and a vital new label
25Gaining Industry Support
26Transportation Technology Advances
- Provides both
- heating and cooling.
- Reliable,
- compressor-driven
- technology.
- On-board
- temperature monitor
27Summary
- Regulation, regulation, regulation
- Challenges of global manufacturing
- Air Cargos changing airscape
- Capacity vs. growth
- Cold chain growing fast(er)
- The air cargo sector is reacting
- Collaboration new technology
28Who depends on us working together?
29Thank You!
- Tony Wright
- tony.wright_at_exelsius.co.uk
- Kevin ODonnell
- kevin.odonnell_at_tegrant.com