LogiPharma USA 2024: Enhancing Cold Chain Insights
A panel offers its perspective on bolstering the temperature monitoring and data sharing process.
The cold chain logistics process—and pharmaceutical logistics in general—often leaves stakeholders with questions surrounding improving both the data visibility and data sharing processes.
Moderated by Tony Fonk, president and CEO of SpotSee, a discussion on “From Clinical to Commercial: Improving Cold Chain Insights Across the Value Chain,” featured insight from Jeff Lander, director of global logistics engineering, Moderna; Alok Bhatt, senior director, global biologics operations, Bristol Myers Squibb (BMS), and Paul DellaVilla, director of digital solutions and services, Cold Chain Technologies. The gentlemen wanted to determine ways to build processes into company policies that can enable better visibility, discuss way to monitor aforementioned data, and the value of partnerships in these efforts.
The value of the last mile
Moderna has been making an augmented customer experience its ultimate priority, with the help of direct-to-pharmacy or direct to patient care-type efforts.
“This year, we put a focus on an enhanced customer experience, to be able to not have something show up that needed to be intercepted, that wasn't in temperature range. We were really striving for call it for lack of better words, an Amazon Prime experience for our end user base,” Lander explained. “So that was real-time tracking visibility, and also the ability to intercept the shipment. It also included if we saw our temperature trending in the wrong direction, if we saw some sort of interruption in the network via UPS or FedEx in terms of a missed flight, to be able to provide the visibility, while also having accurate information in terms of temperature, letting it arrive a day or two longer, and knowing confidently that the product is still viable.”
From a brand management perspective, having high customer service levels are imperative—BMS strives to be at 98-99% for most products. Considering the company’s portfolio, many of its customers or wholesalers or hospitals, would function on three months worth of inventory in some cases. In these situations, last mile is still valuable, but to a different extent. However, adding the cold chain variable makes it more a supply chain integrity concern.
“We cannot be playing with our quality—it's important,” noted Bhatt. “Every time we do not deliver the product and don't have the last-mile visibility, that impacts our customer service level, that affects our impact to the patient itself.”
Cold Chain Technologies’ definition varies in the sense that it is literally the final step—the company is interested in the direct-to-patient type of shipment, which requires a different approach when it comes to packaging, and monitoring services, especially when thinking about specialty pharmacy.
“We work a lot with the wholesalers or the direct pharmaceutical manufacturer, where they're going out to their patient, and they still really have that ownership and control of supply,” said DellaVilla. “You typically see them being a little more conservative—with a little bit more protection—whereas you go to the last mile, which is like a specialty pharmacy application, and this really handled more by the URAC standards than you would say, a traditional FDA standard. You're typically looking to be little more cost conscious because you're shipping a smaller volume, so that might be individual dosing, or one-month supply of pharmaceutical products, so the cost impact and the type of shipping will vary in those places.”
The traceability holy grail
Fonk posed the question on everyone’s mind: What are the realities of achieving accuracy, interoperability, and sharing the information?
“It really depends on the type of supply chain,” commented Lander. “It's different for final-mile distribution than it is for a cell and gene therapy drug; it very much depends on the stability of the drug and the final outcome you're trying to achieve. For us, it's really trying to figure out what that right, protection, trackability to price point really is.”
For Bhatt, this concept of traceability begins at the drug substance level.
“When you think about cost of goods, 80% of the cost of the product is in drug substance, which is API [active pharmaceutical ingredient] right, even before it goes to a vial or a syringe,” he explained, “so at the end of the day, the cost of the product is really something that we want to save for now, depending on what the definition of the holy grail is or not. We want to make sure that we are not over emphasizing on traceability, where we don't have to a lot of time.
“As we move forward, there are cost pressures. We talk about IRA, we talk about ESG goals. That’s a moving target for us, where we are getting pressure as a company, as an industry, to bring our costs down. But then there is the 20% that now we have started to focus on as well, where we want to make sure how much is too much—just because we have something should we leverage that? Does it make sense, what's the strategy, or what's the risk strategy toward it?”
Maintaining product integrity
When it comes to being able to maintain the integrity of the product, DellaVilla believes that success in the area should start with some sort of control that is able to monitor supply chain variability.
“Control is a big part of how the pharmaceutical industry has looked at maintaining integrity of product, and control could be qualified packaging,” he said. “It could be a chemical indicator, it could be a temperature monitor. It could be a real-time tracker. And because there's that much variability in the supply chain and how we were showing control, I think as we get into the details of the Drug Supply Chain Security Act—and starting to understand how that's going to play and need to be monitored—I think what you're going to need to see is different tools evolve for tracking, not just the serialization, but also those excursions you're going to need to get to a place in which you differentiate. It's about how you start to compare those varied methods of control. That's really going to get to the crux of how we approach it.”
Reference
Fonk T, Lander J, Bhatt A, DellaVilla P. From Clinical to Commercial” Improving Cold Chain Insights Across the Value Chain. September 24, 2024. LogiPharma USA 2024. Boston.
