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Security issues continue to vex healthcare product manufacturers

Live from the 'Cold Chain' Forum: High-value pharmaceuticals, biologics, and medical devices retain their appeal as a focus of criminal activity around the globe.

End-to-end temperature management was an often-used phrase during the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum, broadening what many once referred to as the “cold chain.”

Traditionally, the cold chain identified products maintained in the 2°C to 8°C temperature range. But when you add in the ever-increasing focus on Controlled Room Temperature (CRT) products and frozen classifications, it’s understandable why the end-to-end temperature management term is more appropriate.

At the Sept. 30 to Oct. 4 event in Chicago, one of the more concerning sessions was a panel discussion called “Supply Chain Integrity—360 View” that looked at security issues—particularly counterfeiting, diversion, and theft—throughout the life science product supply chain. The panel consisted of Gregg Goneconto, Retired Special Agent, FDA Office of Criminal Investigations; Chuck Forsaith, Director of Supply Chain Security, Purdue Pharma Technologies; Barry Conlon, CEO, FreightWatch Intl.; and Brad Elrod, Director, Global Conveyance Security, Pfizer.

Forsaith pointed to three primary challenges involved in the development of “unparalleled” holes in the supply chain. First, he said, “There’s been a huge escalation in pharmaceutical drug diversion, and the resources [to combat them] have not kept pace.” The second challenge, he noted, pertained to foreign-sourced unapproved drugs in the U.S. supply chain. A third is in compounding pharmacy issues, citing as an example the New England Compounding Center.

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