Focus Day - Bio Clinical and Lab Logistics: Friday, September 30th 2011

8.00 Opening Remarks Chairperson

8.10 Best Practices for Cold Chain Shipping of Biologics

Many biopharma companies experience concerns when considering global shipments of temperature sensitive material. Gain an Operations perspective on cold chain shipping solutions that:

• Ensure clinical trial materials never exceed cold chain temperature parameters
• Address increasingly difficult cold chain challenges for biologics
• Protect clinical trial materials in extreme environments
• Ensure regulatory compliance
• Solve bulk shipping issues

Bruce C. Simpson
Director, Commercial Operations
Fisher BioServices

8.50 Maintaining Cold Chain in Remote Parts of the World: A Solution to a Global Health Problem

In order to eradicate vaccine-preventable deaths worldwide, the vaccination "cold chain, must be optimized to ensure effective delivery. The nonprofit group, Energize the Chain, is working on a solution to this global health challenge. To ensure an adequate and expansive cold chain has the potential to positively impact hundreds of millions of people, Energize the Chain is developing capabilities to use cell phone towers as the energy source to power vaccine refrigerators in remote off-grid locations that currently lack the energy infrastructure necessary to preserve the cold chain. This presentation will explore what this simple, yet revolutionary approach means to ensuring needed vaccines reach people that need them the most, as well as the importance to the private sector. This presentation will explore this and the facts:

• Approximately 75 percent of the world is covered by a mobile cellular signal, and that percentage is expected to reach nearly 100 percent by 2015
• Base stations have a surplus of power capacity of about 5kW for a diesel generator powered BTS and under 5kW for a BTS powered by alternative energy sources
• Considering that a refrigerator unit consumes between 0.5 – 1.9kWh/24h, there is ample power at most cell tower sites today to supply refrigeration units
• These facts equate to a constant supply of energy, sourced from any combination of diesel generators, battery backup, gas turbine and renewable energy to supply power for thousands of vaccine refrigerators

Harvey Rubin MD, PhD
University of Pennsylvania & the Energize the Chain Team

10.00 Clinical Supply Labeling and Returns for Temperature Controlled Study Drug

• Process for tracking multi-lingual / regional label text from a virtual companies perspective
• Setting up a multi-lingual phrase library
• Process of returning drug in different regions from a virtual company perspective

Rebecca Steffen
Senior Operations Specialist
Takeda Global Research & Development

10.40 Establishing Clinical Supply Networks and Partners in Asia

• Understanding local distribution structures
• Sourcing local suppliers with quality control practices to handle biosimilars
• Building standards and agreeing on best practice handling of clinical products
• Temperature control challenges with new and local distribution partners

Staci Hargraves
Senior Director, Global Clinical Supplies
PPD

12.30 Passport, Please? Case Study: Insights and Considerations for the Globe-Trotting Cold Chain Supplier of Investigational Medicinal Material

The proliferation of multinational clinical trials for medicinal products has spurred rising demand for global cold chain supply services. This cold chain supply management case study of a Phase III medicinal product will outline some of the unique challenges in maintaining cold chain continuity to study sites in emerging markets across the globe. This case study will use examples from the Phase III trial to address:

• Security: Protecting against damage, loss, or theft while en route or upon arrival
• Maintenance of cold chain conditions in air and on the ground
• Planning, adaptability and contingency plans to ensure supply continuity
• Required documentation and deciding on the stated value of the material - a complex business decision that carries a certain level of risk
• Regulatory compliance: Ensuring correct valuation of material to decrease any risk of potential delays with many country's regulatory authority agencies
• Improvements in kit design: Smaller, lighter, cost-effective packaging
• Technology enabling tracking of temperature and location: Real assurance

Dan Gourley
Logistics Director, Clinical Supply Services
Catalent Pharma Solutions

1.10 Phase I Clinical Supply Operations and Supplier Management: A Vertex Case Study

• Timelines, requirements and challenges of Phase I clinical operations
• Sourcing new suppliers for new trials that meet our criteria
• Lowering risk and streamlining processes with a single supplier
• Identifying and negotiating clear agreements to avoid delays and extra cost
• Best practices and lessons learned working with clinical logistics, packaging and labeling suppliers

Katy Ostertag
Clinical Supply Planner
Vertex Pharmaceuticals

2.20 Site to Site Transfer of Monoclonal Antibody Clinical Supplies

Chain of custody and continuous temperature control of clinical trial materials (CTM) can impose challenges on the movement of CTM. During this presentation MacroGenics experiences will be shared with the audience. Some of the activities that will be covered include:

• Monitoring supply and 'stock' at each site
• Compliance of handling standards on-site
• Handling and packaging of CTM that must be temperature monitored
• Site2Site Process and documentation
• Lessons learned
• Compliance with FDA requirements

Robert Bronstein
Clinical Supply Project Manager
MacroGenics, Inc.

3.00 Panel Discussion: Clinical Supply Logistics Collaborations

• Communicating expectations and establishing a win-win partnership
• How to get the most out of 3PL partnerships
• Working with partners to reduce cost of clinical logistics
• Sharing risk

4.00 Closing Remarks from Chairperson and End of Day