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Pharmaceutical Makers, CMOs Meet Serialization Challenges Head-On

3rd Serialization Roundtable For CMO’s’ delivers education to a pharmaceutical industry in need.

Jeremy Tatum didn’t mince words when asked how to motivate pharmaceutical manufacturers and contract manufacturing organizations to comply with the Nov. 27, 2017 deadline by which drugs must be serialized by manufacturers: “Don’t serialize, and you can’t sell your products.”

As Director, Enterprise ERP and Serialization for PAR Pharmaceuticals (now an Endo operating company), Tatum encouraged pharmaceutical makers and CMOs to focus on the business opportunities serialization compliance provides, such as “a competitive edge with customers, supply chain visibility, better returns tracking, improved data insights and business intelligence.”

Also taking a glass half-full approach to serialization was Mario Simard, Senior Product Line Manager at Optel Vision. He noted, “There’s an opportunity even for those companies that have not yet started serialization because it can be 15 to 30 percent less expensive to implement serialization and aggregation at the same time,” rather than addressing serialization now, then waiting until the aggregation phase of U.S. Drug Supply Chain Security Act (DSCSA) regulations takes effect.

Simard estimated there are 15,000 global packaging lines that need to be made “serialization-ready,” during the “3rd Serialization Roundtable For CMOs,” held Aug. 30-31 in Chicago and organized by Optel Vision and Supply Chain Wizard.

The pharmaceutical community has a long way to go to become serialization-compliant, which isn’t surprising given the complexities serialization presents, but it is alarming. Event organizers noted there’s “not been as much progress as we’d like,” attributing the slow start to serialization compliance to factors such as a lack of capital commitment and understanding of the technical aspects of the process. They noted the aim of the event was to help CMOs and the pharmaceutical community moving forward.

After serialization roundtable events in Philadelphia in 2015 and in Frankfurt, Germany earlier this year, the message in Chicago was clear: CMOs and pharmaceutical manufacturers have timelines that have to be bridged and need to address them as soon as possible.

Rick Bollinger, Optel Vision’s VP of Sales, North America explained, “We need open communication between partners throughout the supply chain. Communication breeds success and education is a key to that.”

Teva exemplifies the challenges

Teva Pharmaceutical Industries Ltd., based in Israel and producer of generic drugs, specialty pharmaceuticals and active pharmaceutical ingredients, is a good example of a serialization-challenged company.

At the Chicago event, Vivian McCain, VP, Third Party Operations, Americas, bluntly stated, “Serialization has not come along as well as we hoped. We need to address how do we move the needle and get this thing done? We have more than 800 CMOs/external suppliers of our products. Nearly all of them rank near the bottom of the scale in terms of their state of readiness with 15 months left before the November 2017 deadline. That makes me nervous; it’s a huge mountain to climb. We’ve known about serialization for years and we cannot put our patients at risk.”

To “move the needle,” McCain explained the company is working with Supply Chain Wizard and with cross-functional teams, both internally and with external partners throughout the supply chain to better understand the regulatory issues, size, scope and challenges of serialization. “We’re not where we need to be,” he said. "We need to motivate each other, share knowledge, and get this done in time and within budget.”

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