What's New for 9th Annual Cold Chain & Temperature Management Global Forum?
Transportation and Logistics Collaborations
Partnerships is not just a buzzword in temp control pharma - it's here to stay. Today, we
see vendors partnering to offer end to end solutions and we see pharma manufacturers
increasingly outsourcing logistics. Solid partnerships must be built on a foundation of
communication, solid processes and clear documentation. A smile always is nice too.
This 2011 Global Forum focus will show you how companies are working hand in hand
with their 3PL and forwarding partners to overcome barriers in new markets, reduce
logistics cost and comply with regulatory requirements.
Don't miss the unique Panel Discussion 'Developing Global Policies, Networking and
Partners for International Distribution'.
Plus - the first and only Horizontal Collaboration pharmaceutical case study will be
presented by Tri-Vizor, a neutral facilitator, working with Baxter and UCB to share
Bio Clinical & Lab Logistics - a Focus Day
Clinical Trial supply logistics present unique challenges, requiring unique technology and processes. This focused day, will examine the key challenges currently being faced in the industry in shipping biological samples and clinical supplies, from emerging markets to justin- time packaging to GxP compliance. A greater focus will examine how clinical supply stakeholders can work together to ensure no lost time, patient or bio samples. Share best practices with industry leaders and practitioners including:
- Bruce C. Simpson, Director, Commercial Operations, Fisher BioServices
- Douglas E. King, Director, Business Development, Division of Pharmaceutical Studies, DCL Medical Laboratories
- Rebecca Steffen, Senior Operations Specialist, Takeda Global Research & Development
- Staci Hargraves, Senior Director, Global Clinical Supplies, PPD
- Dan Gourley, Logistics Director, Clinical Supply Services, Catalent Pharma Solutions
- Katy Ostertag, Clinical Supply Planner, Vertex Pharmaceuticals
- Robert Bronstein, Clinical Supply Project Manager, MacroGenics, Inc.
Good Transportation Practices for Air, Road and Ocean for Temperature-Sensitive Healthcare Products - a 2 day Training Course
Today, temperature control is part and parcel of a life science supply chain. A thorough understanding of all 'its moving parts' as well as every day challenges and responsibilities are essential to contribute value to its smooth and compliant operations. Learn the importance of SOP’s and Quality Agreements, trends in distribution and take part in practical demonstrations of packaging solutions and temperature monitoring.
Led by two well-known leaders, Tony Wright, Managing Director, Exelsius Cold Chain Management and Kevin O’Donnell, Technical Director, ThermoSafe Brands.
Ambient, Controlled Room or Room Temperature Strategy and Product Focus
Right now so many companies are analyzing and deciding how to implement a CRT (Controlled Room Temperature) or Ambient strategy for their products. But many companies are asking; where do I start? what are the regulatory requirements in the markets I operate in? what are the consequences and expenses? what other costeffective solutions and processes exist?
This focused afternoon will first present two case studies, from big pharma and a small pharma company. Both approaches will be considered to engage all particpants for the 'Ambient/CRT Think Tank'. This program segment will be 'workshop style' - an informal discussion, an opportunity to bring your questions, ideas and even data to discuss your ambient strategy.
AIR CARGO 301 Stakeholder Discussion Forum
Back by popular demand, AIR CARGO Stakeholder Discussion Forum will be part of the main conference for 2011, addressing critical issues faciing today's logistics and QA pfofessaional shipping air freight. Join panelists from around the world - shippers, carriers, forwarders, cargo handlers - to discuss:
- Quality Agreements vs. SOPs and legal legitimacies
- Screening inbound cargo: December 31st, 2011
- New technology examination and challenges: thermal blankets, next generation ULDs and passive containers
- Collaborations: Responsibilities, realistic expectations and communications
Additionally, you will hear:
- An update from IATA - regarding mandatory Time and Temperature Label requirements, standardized audits and the IATA Time and Temperature Sensitive Roadmap
- Insights from experts at American Airlines Cargo how to plan an effective network strategy and integration of partners for your air freight from
- A case study from Johnson & Johnson on how to handle international temperature control air freight shipments
Product Lifecycle - from API to Finished Product
Today, with shipments going into new countries often, your stability data may be questioned. As
they say - 'the proof is in the pudding'. This Product Lifecyle focus will take a look at developing
robust accelerated studies for your distribution environment. Dawn Kreuz, Senior Stability
Coordinator, Merck and Geoffrey Glauser, Biomedical Advanced Research and Development
Authority (BARDA), U.S. Department of Health & Human Services (HHS) will discuss best
practices designing stability studies for specific product and distribution requirements.
Plus, this unique focus for 2011 will also examine product launch and Tech Transfer
from Clinical to Commercial - ensuring product quality from bulk to design to distribution.
Don't miss these excellent case studies:
- Road to Launching a New Biologic Drug by Marc Mostinckx, Senior Director, Head Global Logistics, UCB Pharma SA
- Assuring Successful Tech Transfer from Clinical to Commercial Distribution by Paul Harber, Principal, Modality Solutions LLC, former Engineering Consultant, Eli Lilly and Company
- Development and Qualification of a Robust Cold Chain Logistics Solution for Bulk Biologics by Matthew Olsen, Application Specialist Fluid Management Technologies, Sartorius Stedim Biotech