Global Clinical and Commercial Supply Chain: Protecting Bulk Product with Active Temperature Controlled Systems

Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical, Pharmaceutical Regulation ,
  • Tuesday, April 08, 2014

Whether you manage a clinical or commercial supply chain, the global distribution of bulk product can result in catastrophe without the right game plan. The consequences of a temperature excursion or a delayed delivery can result in the loss of millions of dollars of high value product, a disruption to the supply chain affecting the patient population, and damage to your reputation.

As a result of the volatility of moving temperature controlled product, sponsors and their partners are taking an active role in protecting their supply chain. Armed with industry knowledge and proper planning, you can prevent a disastrous loss of clinical/commercial product.

This webinar will focus on moving clinical and commercial product utilizing active temperature controlled systems. By attending, you will gain powerful information that can help shape and redefine your supply chain. The presenters will share insight from biopharmaceutical industry experts and present actual case studies of overcoming logistical challenges, including shipping to emerging markets.

Find out how sponsors, CMOs and their integral partners are successfully using active units to support global clinical and commercial supply chain with industry best practices. If you are involved with the logistics of critical bulk material, you will not want to miss this webinar.

Key Learning Objectives:

  • Learn how to protect your supply chain from high value losses
  • Prevent clinical/commercial supply disruptions
  • Determine when it is appropriate to use an active unit and which type of active unit you should choose
  • Maintain regulatory compliance with the support of SOPs and experienced logistics partners
  • Consider risk mitigation strategies. Is cold chain/temperature control at-risk?
  • Discover industry best practices to ensure temperature control throughout transit
  • Learn from trends and case studies originating from actual shipments gone “awry”


James Klingelhoefer, Business Development Manager, World Courier

James Klingelhoefer, a Business Development Manager for World Courier, works with customers in the Pharmaceutical industry to leverage supply chain efficiencies. He has extensive knowledge and experience in Temperature Control Management and Drug Distribution. For over 7 years, James has helped sponsors, CMOs, and packaging companies to shorten timelines, reduce costs, and meet the demanding industry and regulatory requirements in the area of global distribution of temperature controlled clinical and commercial product.,

With experience as an international customer service supervisor, James relies on his operational background to strategize with customers concerning bulk product logistics. He works with clients on clinical and commercial projects providing guidance in the areas of; packaging, import/export regulations, route analysis, and distribution strategy. James has spoken at several industry conferences including Institute of Supply Chain Management and Clinical Supply East.

Message Presenter

Tony Mistretta, Distribution Manager, Almac Clinical Services

Tony Mistretta has been working in the Pharmaceutical industry for over 20 years, for the last 12 years as part of the clinical supply chain. He graduated from Delaware Valley College with a BS in Business Administration, and currently works out of Almac’s North American Headquarters in Souderton, PA. Tony’s current role is as Distribution Manager with Almac Clinical Services, a role he has held for the last 10 years, dealing with clinical shipments with varied temperature demands to a range of destinations, utilising different shipping solutions. Tony also lends his expertise to various summits and workshops globally to enhance the knowledge base for clinical shipping.

Message Presenter

Who Should Attend?

VPs, Directors, Managers in:

  • Clinical Operations
  • Clinical Development
  • Clinical Supplies
  • Commercial Distribution
  • Transportation
  • International Shipping
  • Quality/Quality Assurance
  • Logistics
  • Supply Chain
  • Materials Management
  • Material Handling
  • Inventory Contro

Xtalks Partner

World Courier

Incorporated in 1969, World Courier is the leader in specialty logistics for global clinical trials delivering fully-integrated GxP-compliant temperature-controlled transport, storage and distribution solutions worldwide in over 10.000 clinical studies. World Courier has a network of over 150 company offices operating in more than 50 countries plus a network of 13 x GMP compliant storage depots in strategic locations.

Through its company-owned network of offices World Courier provides door-to-door, customs-cleared service to more than 220 countries and territories and sets the benchmark for temperature controlled, time sensitive transportation.

As Cold Chain shipments face increased scrutiny from internal bodies and international agencies alike, strict adherence to temperature control is critical for compliance with international regulatory, manufacturing and safety standards. With our proven track record in Cold Chain Management, World Courier is the only specialty logistics provider that offers comprehensive and customized temperature-controlled transportation services 24/7/365 worldwide.

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