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Temperature-sensitive logistics market in state of flux

Healthcare Packaging Publisher Jim Chrzan shares observations from Cool Chain Logistics Europe in Basel, Switzerland.

The temperature-sensitive logistics market is in a state of flux (note the shift from Cold Chain to Cool Chain) and there are many more questions than answers here at the 12th annual Cool Chain Logistics Europe 2013 in Basel, Switzerland, the center of pharmaceutical manufacturing in Europe.

There is no doubt the cold chain is evolving to include every range of temperature control, with a special focus on Controlled Room Temperature (CRT) for drug maker’s ambient products.

A quick poll of the IQPC event audience revealed many end users and solutions providers, but few regulators—who really need to be here!

Regulatory authorities are getting tougher as countries such as Australia and Saudi Arabia hold up shipments due to temperature variations, quarantining them until they are offered proof the drugs can withstand temperature extremes.

There is also increased focus on the last mile of distribution, which now includes not only the clinic or hospital, but also extends to the patients who need better training on how to store their temperature-sensitive drugs.

Additional observations:

• More technology and more solutions providers are entering the marketplace, but add to the “static.” The goal, according to keynote speaker, Dr. Ravi Prakash Mathur, director of Supply Chain Management for Dr. Reddy’s Laboratories in India, is to separate the signal from the noise.

Linear change, he said, is urgent in the short-term, is efficient and predictable and repeatable.  Managing linear change is restructuring to close the performance gap. It is for today.

Non-linear change is important in the long-term, flexible, non-routine, and uncertain. Managing non-linear change closes the opportunity gap and means renewal.

• The blockbuster paradigm is gone.  According to Dr. Mathur, in the next six years patents will expire on drugs generating $267 billion in sales.

Not only has generic competition changed the landscape, but more sophisticated, flexible production techniques will change drug development.

• Non-linear change resets the table, Dr. Mathur told the packed house.  Staying where you are in not an option.

• Pharmaceutical and biologic drug manufacturers looking for a road map from regulators are going to have to wait a little longer, at least in the European Union!

The new EU GDP (good distribution practices) guide is due out any day, said Riekert Bruinink from the Dutch Healthcare Inspectorate.  Bruinink is a member of the EMEA (Europe/Middle East/Africa) GDP drafting group.

It should be noted that his comment about it coming out any day drew laughter from the crowd, who have been waiting two decades for an update in a world that has changed considerably.

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