Show preview: IQPC cold chain and temperature management global forum

Show preview: IQPC cold chain and temperature management global forum

July 16, 2012

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Pharmaceutical CommercePharmaceutical Commerce - July/August 2012

This year's IQPC meeting - its 10th anniversary - promises to be the biggest yet

About 50 exhibitors were already signed up in late May for the Sept. 24 IQPC Cold Chain Global Forum, which has evolved into the premier global event for this sector. The expectation of even more exhibitors, plus an expanding technical program, are probably two of the reasons that the event is moving to the massive McCormick Place center in Chicago; IQPC spokespersons also say that they’re looking to move the

event around from year to year, to allow for a broader cross-section of industry involvement.

The foundation for such growth, of course, is the pace of development within industry itself: Pharmaceutical Commerce’s market study, the 2012 Biopharma Cold Chain Sourcebook, projects the life sciences cold chain market to reach $7.6 billion in logistics services, packaging and instrumentation in 2013; and $8.9 billion in 2016. To that can be added the estimated $2.5 billion in clinical trial logistics, resulting in a +$10-billion market.

One of the key drivers of increased volumes of cold chain shipments is, of course, the increasing number and volume of biologically derived products going on throughout the industry. But another—and one that highlights the logistics component of this sector—is the push by multinational pharma companies to increase their sales in emerging markets. In countries such as China, India and South America, not only is the logistics train longer, but the availability of reliable, safe transportation services is harder to acquire. That puts an extra burden on logistics providers—for the pharma industry to be successful in globalizing its markets, it will depend more heavily on expert logistics services. At the same time, health authorities in these emerging markets are, if anything, more restrictive than in the developed markets for ensuring that temperature controls have been maintained when products arrive in-country.

These global issues will be well-represented at the Global Forum: keynotes from FDA and the UK’s Medical Health Regulatory Agency are expected on Day One (Sept. 25; this session is preceded by a workshop on the 24th), to be followed by a panel discussion on international regulatory requirements in emerging countries. Scheduled tracks for the first day’s sessions are:

Cold chain packaging engineering
Global supply chain & logistics
Stability management and supply chain data.

The stability management topic is of interest because it represents something of an unmet need by industry: how to “share” the time a shipment might spend out of its temperature-controlled range, among organizations that are successfully storing, shipping and delivering drug—and still meet the stability requirements of the drug label. Representatives of Eli Lilly and Temperature Sensitive Solutions will be leading sessions; there is also a panel discussion.

Day 2

On the second day, the afternoon sessions are scheduled to provide another set of issues:

APIs & bulk handling
Quality distribution & risk management
Supply chain security & tracking
Clinical supply.

The security & tracking sessions bring a new element into the cold chain arena—the utility of unit-label barcoding (or RFID tags) to enable tracking of dosages throughout their distribution. The “track and trace” debate has been raging for years, and (as of this writing) is a component of the legislation to reauthorize the Prescription Drug User Fee Act (see p. 8), as well as on the books for compliance in California in 2015. In theory, barcode tracking will enable better alignment between compliance elements, like temperature records and specific shipments, along with a host of other potential benefits. But the implementation of this—and then the synchronization of tracking data with condition monitoring—remains a challenge. Representatives of the GS1 organization (which has developed barcoding standards for pharma labels) will be speaking; the session will close with a “tabletop exercise” of a hypothetical cargo theft and how to respond, led by Chuck Forsaith, head of the Pharmaceutical Cargo Security Coalition.

IQPC is also laying in other conference innovations: a live survey where the audience will have handheld clickers to respond on the spot to questions; and (on the third day) a full slate of sessions devoted to cold chain shipping in Central and South America.