Day 3: Main Conference – Wednesday, September 22, 2010

7.50 Opening Remarks From Chairperson

Transportation and Security

8.00 Keynote Address: TSA Certified Cargo Screening Program: Post August 2010 Deadline

• Industry progress
• Cost considerations for implementing

Gary E. Lupinacci
Assistant Branch Chief, Certified Cargo Screening Program, TSA/TSNM
Department of Homeland Security

8.40 Supply Chain Security & Risk Mitigation Practical Measures

• Current trends and best practices to reduce risks in the supply chain, warehouse facilities and in-transit cargo
• Working as an industry to indentify and mitigate risks
• Use of technology to capture real time information that ensures products do not incur temperature or supply chain deviations
• Experience and feedback from local authorities on how to conduct best practice communications about high value medicines in distribution

Carlos Velez
Worldwide Security Director
Johnson & Johnson

9.20 Security & Control In The Pharmaceutical Temperature Control Supply Chain

• Global trends effecting security, complexity, and temperature control within the pharma supply chain
• How to continue to maintain quality within the transportation process in spite of increasing difficulties
• Understanding the different transportation models and what the appropriate expectations are of each partner in the process
• Technological advancements assisting the security aspects during transportation in the pharma supply chain
• The effective layering of security options depending upon the needs of the cargo and the interests of the parties involved

Karl Kussow
Manager of Quality
FedEx Custom Critical

10:00 The Importance Of Developing A Collaborative Model To Ensure Secure Air Transit Of International Of Temperature-Controlled Products

• Manage regulatory hurdles effectively for cost containment in challenging environments
• Maintain product integrity from end-to-end through effective planning and collaboration among supply-chain partners
• Execute strategically through effective communication practices
• Understand how an effective shipment lifecycle process creates successful outcomes

Dave Brooks
President
American Airlines Cargo

11.25 Bridging The Gap With Air Transport: Meeting Industry Critical Standards And Devising Effective Contingency Plans

General air cargo processes are insufficient to support the stringent requirements of pharmaceutical cold chain logistics, particularly the newer “biologics” and even the traditional compounds now facing tougher regulatory standards. Upgrading management capabilities to meet these standards requires education in pharmaceutical handling, training in cold chain processes and advance planning for each shipment, all completed, documented, and tested before the first shipment is handled. When all runs as planned, these SOPs for air cargo provide a secure and robust system that may be included in the overall cold chain. Unfortunately, all aircraft are subject to uncertainties due to weather, unplanned maintenance, or other factors that can force plans to change. The risk associated with exterior events can be mitigated with thorough advance planning, documentation and communication. Planning and understanding of shipper requirements leads to success. In this presentation we will discuss:

• How specialized handling processes and contingencies ensure safe and rapid transit of pharma products
• The role of shipper, freight agent, and airline in preparing air cargo standard operating procedures
• Gaining control of the air cargo portion of cold chain through simple, robust processes
• The importance of transparency into shipper requirements and airline capabilities
• Live examples of when contingency plans were employed and why preparation was critical

12.05 Optimization Of A Passive Pallet Shipping System For International Vaccine Transport

• Identify, analyze, and prioritize demands from multi-national task forces
• Design and development overview of the next generation pallet shipper
• Product attributes that help overcome challenges in international vaccine transport
• Thermal performance review

Temperature Mapping and Profiling for Cold, CRT and Ambient Products

4.15 Temperature Mapping North American Supply Chains

• Designing a study for transportation from multiple Distribution Centers within the US
• Examples of seasonal temperatures & mapping results
• Sourcing multiple solutions for temperature compliance of CRT or Ambient products
• Monitoring of solution's performance to our defined standards

Alan J. Davis
Supply Chain Temperature Control Leader
Johnson & Johnson

4.50 Panel Discussion: Controlled Room Temperature Products: Working With Partners To Meet Regulatory Requirements Cost-Effectively

• Working with packaging providers to find more cost-effective solution
• How do carriers handle CRT Products: Do transportation providers have a helpful solution?
• What are the temperature ranges if we don’t have the stability data?

Panelists:

5.30 Closing Remarks From Chairperson

6.00 - 8.30 Workshop G: Evening Networking Seminar: AIR CARGO 201

(Registration 5.30, Dinner will be served)

At last year's Cold Chain conference, the 'Interview with an Airline' Panel Discussion was a popular session and yielded great insight into how airlines handled temperature controlled pharmaceuticals. Finally airlines 'had a voice' and pharmaceutical manufacturers got a clear picture as to what cold chain best practices airlines adhered to.

With the IATA Chapter 17 July 2010 deadline and the TSA 100% Screening August 2010 deadline, this Evening Seminar will be a great opportunity to gage the progress of airlines and supply chain stakeholders implementing greater control and visibility into shipping temperature sensitive air freight. Have these regulations made an impact on operating a robust cold chain in the air? (and on the tarmac!)

The Evening Seminar will provide an opportunity for air carriers, shippers, freight forwarders and 3PLs to discuss remaining gaps in shipping temperature sensitive air freight.

Interview with an Airline - Part II:

• What differentiates your product and process from other temperature controlled air cargo operations?
• What are your experiences to date working with industry or companies to develop that process?
• What have you learned to create a sustainable process to support shipment of temperature controlled pharmaceuticals?
• How are you ensuring your agents and ground handlers are adhering to Chapter 17 guidelines?
• Can agents realistically adhere to Chapter 17 and maintain 15-25°?
• How do you define your service levels and agreements with agents? If issues arise, how are they resolved and how are risks mitigated?
• How are you working ISO standards into your Quality Management System?
• How can industry standardize training and auditing of facilities?
• How are you adjusting your airline procedures to adhere to TSA Screening requirements?

Discussion Points:

• Handling airport infrastructure obstacles in different parts of the world: Discussing examples in India, Doha, Chicago, Dublin, London and Japan
• New 'pharma centers' for distribution at India's airports
• Ensuring a collaborative and responsible approach between the shipper, freight forwarder agent and airline
• Filling gap between capacity and growth demand: What are airlines doing to match capacity with demand?
• What can industry to do get greater cooperation across supply chain to help improve the supply chain process?

Submit questions to discussion leaders to courtney.becker@iqpc.co.uk before the seminar.

Seminar Moderators:

Panelists: