Leading Minds Seminar 2018: Managing risk, measuring stability


Participants hear about USP guidance updates, industry best practices in cold chain

Sponsored by Elpro, a leading provider of dataloggers and other temperature-monitoring equipment, and Sonoco ThermoSafe, a leading provider of temperature-controlled packaging, the Leading Minds seminar is intended to be an information-sharing session among industry participants, especially when disparate parts of the pharma supply chain, from manufacturer to wholesaler to transportation provider come together. The meeting (June 6-7) brought about 75 participants together at Normandy Farm, a hotel/conference center in Blue Bell, PA.

A recurring theme of the meeting, chaired by Geoff Glauser, a consultant with the Biological Research and Development Authority (BARDA) of HHS, is the stability budget of drug substances—when they are part of a clinical trial; when product launch is approached; and when the full life cycle of the drug during commercial exploitation is experienced. Glauser notes that the Centers for Disease Control (CDC), a sister agency to BARDA, will allow for pricing premiums for CDC vaccine and drug stockpiles, when the manufacturer does the testing to ensure that the drugs can be kept stockpiled for extended periods of time.

A variety of speakers, including scientists, pharmacists and engineers from Biogen, Merck, NIH and Elpro, explored the intricacies of measuring stability, making use of stability budgets in various stages of a cold chain shipment, and applying risk-based considerations to temperature excursions during shipments. Jeffery Carrico, PharmD, chief of clinical pharmacy and investigational drug research at HHS, noted that NIH sponsors upwards of 500 trials a year, and managing trial logistics is a challenge. “Everyone knows that the key factors are distance, time and temperature when it comes to maintaining a compliant trial logistics process, but verifying this in an auditable fashion is difficult,” he noted. One example: how to track a drug being tested, when the drug sample itself is blinded to investigators and patients.

Another range of factors affecting stability is not just measuring the effects of TOR (time out of refrigeration), but also freeze-thaw cycles, temperature spikes, and changes to a drug formulation between the clinical testing stages and final composition.

Chris Anderson, director of quality systems at Cardinal Health, and a member of the expert committee at US Pharmacopeia, gave an update of USP <1079>, Good Storage and Shipping Practices, which has been under an update cycle since 2016, and for which a draft version is going to be published in July. USP will be soliciting comments on the draft through the end of this year, and in February, a committee vote is scheduled for making the new version a final guidance. In general, says Anderson, risk-based approaches to managing storage and shipping practices will be a key part of the update.

Other sessions at the meeting included the challenges of controlled room-temperature (CRT) shipments, temperature monitoring protocols, and evaluating active versus passive shipping containers with a risk-based perspective. Dirk Rodgers, global regulatory strategist at Systech International, and blogger at RxTrace.com, gave an update on blockchain as applied to pharma supply chains. Vishal Khushalani, director of global marketing at Sonoco ThermoSafe, outlined an evolving approach to the economics of reused cold-chain packaging, in which programs tailored to the shipping lanes, the types of packaging materials, and the shared responsibilities of the shipper and the packaging provider, can be worked out.

The meeting concluded on the second day with guided tours of a Sonoco ThermoSafe facility, and an Elpro user group session.

Leading Minds is planned to be an annual event for the Sonoco ThermoSafe / Elpro collaboration. More information is available here.

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