Can E-Pedigrees Get Some Love?

New, tougher laws are imminent, but few manufacturers fully understand electronic pedigrees, much less appreciate the benefits that chain-of-custody data may provide.

By Paul Thomas, Managing Editor

What a difference a few years make. Two years ago at New York's Interphex show, SupplyScape's chief strategy officer Robin Koh spoke before a standing-room-only audience about RFID's potential and what it could mean in terms of drug product authentication.

This year, Koh spoke before an audience of, well, three — two, not counting the press (i.e., me). Perhaps it was because his topic — the success of the Drug Security Network pilot, the first test run for a comprehensive electronic pedigree program — wasn't quite as sexy as RFID was two years ago. But it also has something to do with the fact that the e-pedigree topic just hasn't put fear into manufacturers the way that RFID and the Wal-Mart mandate did.

The funny thing is, Koh says, is that unlike RFID for authentication, e-pedigrees (whether done via RFID or not) are actually required by law — and stiffer laws are not far on the horizon. Florida's new law takes effect July 1; California's kicks in on January 1, 2007.

The California legislation should really get manufacturers' attention, Koh says, because it places the responsibility of initiating an end-to-end e-pedigree solution on the shoulders of the manufacturer. And anyone thinking that the states will exercise leniency will probably be mistaken, Koh says.

Koh comes from MIT’s Auto-ID Labs and has been sort of a pied piper for the electronic pedigree movement, but is quick to point out that pedigree does not equal product authentication, nor is RFID a prerequisite for its implementation. Electronic pedigrees document a product’s change of ownership throughout the supply chain. In this way, they can be likened to the title of an automobile, Koh says.

What distinguishes e-pedigree software such as SupplyScape’s is its ability to “lock down” relevant information at each link in the chain of custody, so that any attempt made downstream to alter upstream data will cause the pedigree to fail. “Just as dangerous as a counterfeit product is a counterfeit pedigree,” Koh says.

Another clear leader in the e-pedigree market is Cyclone Commerce, whose roots in b-to-b software infrastructure are deep. An e-pedigree solution was a natural outgrowth of what Cyclone had been doing for many years, says Brenden O’Connor, GM for industry solutions. Cyclone electronic gateways have been in use at FDA and EMEA, for example, to handle documentation from industry such as new drug applications and adverse event reporting.

“We focus on a platform solution,” says O’Connor. “Customers can rely on us for basic electronic connectivity, and they can layer on top of that other solutions,” such as brand protection, anti-counterfeiting and e-pedigree. Cyclone is pushing for an open, standards-based solution so that supply-chain partners with disparate hardware and software can still share data effectively and seamlessly.

O’Connor does not believe that manufacturers will take the tougher state pedigree laws lightly, but some will see the opportunity that e-pedigree offers. “Manufacturers are pragmatic,” he says. “They’re going to do what they need to do. But leading-edge manufacturers will take it one step further and look at how to leverage [pedigree information] for other benefits.

While pedigrees are slowly becoming a sexy topic, and many software vendors are now promoting their ability to handle electronic pedigrees, O’Connor believes that competitors in the pedigree solution market will remain few, as long as laws are made at the state level. “The ability of a company to keep abreast of what’s happening in a particular state government will keep away smaller niche vendors,” he says.

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