Cold chain logistics have become increasingly important; not only for drug manufacturers, but also for central laboratories as lab testing and support services have become more complex and global. Sample management plays a vital role both during and after clinical trials and methods for ensuring high quality, properly preserved specimen samples have become even more critical.

Molecular oncology in particular has grown tremendously, and this type of research requires precise handling of specimens during transport. Biological samples require documented compliance for critical factors such as temperature stability and monitoring, and tracking. The biggest challenge today for cold-chain specimens is globalization of clinical trials to underdeveloped or remote locations, amplifying logistic challenges for these extremely sensitive samples.

LabConnect, a global central lab providing routine and esoteric lab testing, kit building, sample management, biorepository and scientific support services for biopharma, medical device, and CROs, is seeing increased demand for advanced biorepository capabilities to support current R&D trends.

In the following interview, Eric Hayashi, president and chief executive officer at LabConnect discusses best practices in cold-chain specimen logistics and long-term biorepository storage of biological samples for risk mitigation and later study, as well as R&D trends such as biovisualization techniques.  –KB

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Contract Pharma: What are the critical factors associated with cold chain logistics in drug research?
Eric Hayashi: The operating environment in a highly regulated industry like biopharmaceutical research requires documented compliance. Extreme care must be taken to provide monitored shipping kits and to follow predefined logistics processes that ensure clinical samples are transported safely and efficiently within a narrow temperature range. Among the critical factors are planning and contingency planning, packaging that ensures temperature stability, continual and verifiable temperature monitoring, and a sample tracking system that enables individual samples to be accessioned and tracked from collection, through lab analysis and finally to biorepository storage.

CP: What are the main challenges associated with cold-chain specimen logistics and how can they be overcome?   
EH: One challenge the globalization of clinical trials has created is that more and more investigative sites are in developing countries with still-developing roads and logistics infrastructures. The relative uncertainty of transportation in these regions means shippers need to build in additional safety margins to ensure sample integrity. Although dry ice packs and insulated packaging may be used for short distances when the risk of delay is low, shippers in these regions today also rely on advanced liquid nitrogen (LN2) containers that can ensure samples remain in a frozen state for extended periods of time.

CP: What specialized services are needed to support cold-chain specimen logistics?
EH: Centralized sample tracking systems, such as LabConnect’s SampleGISTICS service, are designed to simplify the monitoring of the logistics process and keep the plan on track through our “virtual accessioning” process that quality-checks requisitions as soon as samples have been collected at the investigator site. In this way, sponsors can focus on monitoring the viability of individual sample assets throughout the logistics process and also consolidate sample data within a single, centralized database. Once the ID has been assigned, the sample can be tracked from site to lab to biorepository on computers or mobile devices, giving sponsors knowledge and control.

CP: How can these services help to advance clinical development efforts?
EH: Sample management plays a vital role both during and after clinical trials. Samples may need to be retested for regulatory compliance, data or drug-safety issues, or as part of a future genomic, proteomic or biomarker research initiative. In an era when significant scientific advances can be realized in post-analysis, methods for ensuring high-quality, properly preserved specimen samples have become even more critical. Clinical researchers in almost every field of study have come to realize that ongoing and long-term access to properly managed, well-annotated samples is critical to developing new diagnostics and therapeutics.

CP: What role does logistics management play in drug development?
EH: Logistics management enabled the spread and democratization of clinical trials from being the sole province of hospitals and universities to investigative sites in all corners of the world. In addition, companies have found that focusing on and optimizing their clinical trial supply chain operations can provide a strategic advantage to accelerating current and future drug discovery. With the advent of molecular and other analytical technologies, properly preserved biospecimens are the foundation for breakthrough therapeutic treatments and represent assets that can bring significant long-term value to an organization from both a scientific and commercial perspective.

CP: What R&D trends are currently impacting lab services?
EH: Research being done at the molecular level is the new frontier in R&D.  Genotyping and gene expression therapies have been developing for some time, but at the forefront of preclinical and clinical development these days is molecular oncology. This research involves a variety of approaches including genomics, imaging and in vitro and in vivo functional models. Of necessity, this kind of research requires meticulous handling of specimens in transport, in testing and in their final storage in the biorepository.

CP: Are you seeing increased sponsor/CRO demand for specific services/areas of expertise?
EH: Sponsors and CROs are just starting to explore the benefits of big data that come from analyzing huge amounts of aggregated information with the intent of revealing patterns that would otherwise remain hidden. Biovisualization is a technique that blends biostatistics, bioinformatics, computer programming and operational research to enable effective data mining and ease of multidimensional data interpretation. More and more often, this kind of data analysis is being done concurrently with clinical trials so that scientists can understand and react to underlying trends in the data. For example, one of our clients recently discovered that certain subjects were experiencing adverse side effects through biovisualization analysis of the data.

CP: Based on demand/research trends, are there any specific areas LabConnect is looking to add capabilities or expand?
EH: At its heart, LabConnect is a global network of advanced central laboratories that are unified through a regular and rigorous harmonization process. Even though we have resources in place in most regions of the world, we are continually seeking to add new qualified laboratories to our network in developing countries. We also recently expanded our biorepository capabilities with the construction of a state-of-the-art biorepository capable of handling eight million samples in temperatures ranging down to -190 degrees Celsius. 

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Eric Hayashi’s experience includes more than 22 years in the clinical trials industry. He currently serves as president and CEO of LabConnect, a provider of global central laboratory services, including routine and esoteric laboratory testing, kit building, sample management, biorepository and scientific support services for biopharmaceutical, medical device and contract research organizations.