10 Years On: Geoffrey Glauser, U.S. Department of Health & Human Services on the Annual Cold Chain & Temperature Control Global Forum

Contributor: Geoffrey Glauser
Posted: 12/18/2012
Geoffrey Glauser
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The Annual Cold Chain & Temperature Control Global Forum celebrated its 10th anniversary, at the Hyatt Regency McCormick Place, Chicago in September 2012. The event examined the modern cold chain – including all temperature range products and their regulatory requirements – as well as evolving sectors such as Medical Devices & Diagnostics, Generics, APIs, Clinical and Biologics and cell therapies.

Find out what Geoffrey Glauser, Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health & Human Services (HHS), had to say about the event in his post show report.

The opening of the 2012 IQPC Cold Chain and Temperature Management Global Forum started with regulatory updates from the United Kingdom’s MHRA and US Pharmacopoeia. This update seems to put the remainder of the conference in context, by establishing a basis for perspective for understanding and interpreting other presentations, as well as the proposed industry solutions on display.

The patient-first approach to cold-chain product movement was apparent by the subject matter contained in the Networking Roundtable discussions, covering such areas as "Vaccine’s True Last Mile: Providers Office Storage & Handling Practices", "Practical Considerations for Freezing Phase Change Materials", and "addressing Regulatory Challenges on Shipping Temperature Sensitive Medicines to Brazil." These open table forums drew significant back and forth discussions which allowed for input from any of the participants in a contributory way. The key to the success of this meeting methodology is active input, while focusing on factual understanding of the subject matter. In this way participants can experience a two-way communication in internalizing specific information.

Future industry direction: Solution providers are definitely focusing more on hard data when presenting their offerings. This allows for the listener to make better informed decisions when it comes to the specifics of their product or situation. It is hoped that this trend continues in a scientifically-supported way. Carriers continue to play a larger communicative role in temperature controlled transport. Since the life cycle of temperature controlled products involves any organization or section of industry that touches the medicine or other temperature sensitive material, participation of those organizations and companies is ultimately critical to the successful administration of that therapy. There are more technical offerings than ever before as the demand for them grows. This trend will continue to some extent as pharmaceutical manufacturers determine which of their product lines require, or do not require, specific temperature control measures. This focus will gradually extend into controlled room temperature products more and more, as companies gather the necessary data to support their position.

Regulatory decisions and impacts (EMEA, FDA, USP): The regulatory positions that were offered and discussed throughout the conference focused on specific incidences, as one would expect, rather than broad-swath changes. Those observations tended to center on individual activities rather than policies, mostly due to the nature of the industrial audience represented by operations and local decision makers rather than senior policy executives. With regulatory activities, changes are more gradual. That take-away remains supported based upon the results of this conference.

New temperature control solutions:
There were any number of new solutions offered at the 10th Annual Cold Chain & Temperature Control Global Forum, perhaps more than any year in the past ten. They covered the gamut from quality modifications of existing insulated containers to completely new offerings with thinner vacuum insulated panels, and variations of phase change materials both in size and chemical composition. Temperature monitors and data loggers also are undergoing a vast series of changes, expanding their capabilities by offering varying computer connectivity, data sorting, temperature ranges, numbers of data points, and user-friendly configurations. Vendors offering either direct air transport solutions or support services also joined the area with varying technical products focusing more and more on flexibility and service.

Review of supply chain activities: There were more presentations and discussions that were inclusive of the extended supply chain, such as incorporating the concepts of trace & trace, product security, and recognition of international shipping standards put forth by the air regulatory authorities (E.g. IATA and ICAO). As pharmaceutical and biological temperature controlled supply chain transfers become more and more of a product safety and efficacy obligation, other aspects of movement control and smooth integration of activities will be important. Expect to see more labeling, track and trace, security, and environmental issues blended into traditional temperature controlled shipping processes.

As we enter into 2013, we can expect to see greater focus on wider logistical challenges, alongside general temperature control. The key issues raised by the global forum, will continue to be pertinent to the industry.

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Geoffrey Glauser
Contributor: Geoffrey Glauser