Boasting a broad range of attending companies such as Eli Lilly, Patheon, Pfizer, Amgen, Sanofi, and others, NEXUS 2016 kicked off with an extensive coverage of the supply chain, the Drug Supply Chain Security Act (DSCSA), serialization, and mastering global traceability.
Serialization is “one step in a much longer journey ahead of us,” said Shabbir Dahod, President and CEO, TraceLink. Transforming the supply chain is going to take “not just a lot of individual work, but a lot of collaboration as well.”
“It’s one step in a much longer journey ahead of us,” he continued in his opening remarks.
Following on his heels, Sanjay Sarma, Adviser, TraceLink, was the next to speak. His comedic coverage of the unrecognized importance (and centrality) of architecture had the audience not only laughing, but reflecting on his initial statement: “Industries take off when there is a simple, dominant architecture.”
However, good architectures are often counterintuitive.
Sanjay Sarma, Adviser, TraceLink
When polling the audience as to the most important aspect of software architecture—offering integrity, performance, ability to customize, and security/reliability as four options—the NEXUS attendees voted in favor of security and reliability.
Sarma cautioned the audience that, when it comes to IoT, we must have our cake and eat it to. Meaning, it’s important to have both integrity and performance, which often involves brutal engineering from the ground up.
Edsel Pereira, Sr. VP, Information Technology, Glenmark Pharmaceuticals, detailed some of the challenges of track and trace:
- Changes in processes
- Handling product recalls
- Integration with various applications and stakeholders across the supply chain
- Impact on operating cost and cycle time
- Different standards and legislations across the globe
- Data harmonization across applications
- As well as many more
In the South Korean compliance panel, featuring Pfizer’s Kurt Wieditz and Abbott’s Cyndi Poetker, one of the biggest concerns covered was that of aggregation—specifically that some companies choose to aggregate and some don’t. With aggregation not being required by law in order to be in compliance, this can be a pretty sticky area for many companies operating in the pharmaceutical supply chain.
In Korea, specifically, there was also a major concern regarding products excluded from serialization but not the country’s reporting system. For companies such as Abbott, both serialized and non-serialized products are shipped together, which can create complications.
Wieditz encouraged companies to take advantage of test environments and pilot activities as the DSCSA implementation is underway (before the hard deadlines).
In a panel on the DSCSA and its impact on the pharmaceutical supply chain, the panelists revealed some of their greatest challenges and concerns.
“The hardest thing was changing our DSCSA processes,” said Trevor McGee of Value Drug. “We had to do this several times.”
Greg Wozniak of Excellis Health Solutions said that two of the greatest concerns he is seeing, with regards to the DSCSA, is interpreting regulations and grandfathering (particularly since companies are entering into the traceability movement at different times). McGee added that deadlines and gray areas were also common areas for concern.
Steve Rudner of Vizient said: “Everyone has a role in supply chain management, and that is to improve efficiency.”
Stay tuned for coverage of the second day of NEXUS tomorrow!
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