Case Study:
Global Ultra-Cold
Clinical TrialLogistics

APIBIOLOGICSEARLY & LATE PHASE DEVELOPMENT

CLINICAL TRIAL SOLUTIONSLOGISTICS SERVICESCOMMERCIAL MANUFACTURING

Introduction
According to Pharmaceutical Research and Manufacturers of America(PhRMA), biopharmaceutical researchers predict a 69% increase in thenumber of personalized medicines in development over the next five years.
Increasingly these advanced, customized therapies demand a cold supplychain. The globalization of clinical trials, the prevailing infrastructure andregulatory environment can significantly impact the design of that supplychain. Even the largest pharmaceutical manufacturers can find the required
logistics support to be a maze of confusing and at times, daunting options.

Biopharmaceutical researchers predict
a 69% increase in the number of
personalized medicines in development
over the next five years. Increasingly theseadvanced, customized therapies demand acold supply chain.

The Challenge
A new United States-based biopharma working on its first cell therapy-based
treatment had expanded the scope of their trial and extended its patient poolto include a patient in Beijing, China. Although sophisticated and advanced intheir research capabilities, the organization had limited resources and logistics
expertise on how to transport its IMP to China. This presented a number ofchallenges:• Identify and secure a shipper solution to maintain a cryopreserved sample• Understand and obtain specialized permits required in emerging market• Minimize risk of import clearance delays• Provide final mile white glove delivery
The biopharma company turned to their current transportation supplier forguidance, but the complexity of the process proved too challenging and they wereunresponsive.

2The Solution
The biopharma reached out to Thermo Fisher Scientific. When the Thermo Fisher
Corporate Account Manager learned of the impending need for logistics support,
they engaged the services of their specialty logistics colleagues.
The Patheon specialty logistics service offering includes customized logistics
solutions for the life sciences industry. With specific expertise in specialized
transportation solutions, the global logistics specialists had the required
experience and resources to accept the challenge.
Working closely with the biopharma’s clinical trial project management team, thespecialty logistics team designed an end-to-end solution that would meet theirneeds.
In order to ensure stability of the cell therapy liquid nitrogen (LN2) dewar wasrequired as it would have sufficient hold time to maintain the sample through final
delivery to the investigator site. Because the purchase of a dewar for a single
shipment was costly, they engaged their Fisher Clinical Services colleagues toprovide a reusable ultracold shipper, enabling a cost-effective one-time ‘rental’ ofa preconditioned dewar.
While arrangements for the pre-conditioned dewar were being made, the specialty
logistics team served as a consultant to the biopharma, providing additional
support, including:• Identification / creation of Harmonized Tariff Schedule (HTS) codes foreach cell line shipping to China• Assistance in obtaining required export and import permit applications• Arrangement of transportation for each leg of the shipment, including
white glove final delivery

Once the required permits were in place, the team remained on alert pending
notice from the biopharma company that the sample was available and the patient
was ready. When the shipment was activated, they provided detailed oversightand reporting for each leg of the journey, including the reverse logistics of thedewar return to Fisher Clinical Services.

Conclusion
With a shared vision and purpose, i.e. to help customers to accelerateinnovation and enhance productivity, the Thermo Fisher Scientific teamquickly collaborated to provide a solution that specifically met the uniqueneeds of this biopharma. Depth of experience, specialized expertise andpersonalized consultative support were essential to ensure success.

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Published 01/19 PSG0756