As biotech leaders prepare for the implementation of the Drug Supply Chain Security Act (DSCSA) while navigating a rapidly changing market, they’re encountering unique challenges that are testing the resiliency of their logistics plans.
According to a recent Cardinal Health and BioPharma Dive survey among 150 logistics executives, 29% and 24% of respondents, respectively, said that improved temperature control solutions or stronger regulatory support/guidance would be the single factor that would most improve their logistics needs.
The findings point to shifting priorities in an industry marked by regulatory developments, economic uncertainty, and scientific innovation across cell and gene therapies—and they’re emphasizing the importance of third-party logistics partners, known as 3PLs.
Two-thirds of respondents—66%—said that they expected 3PLs to become increasingly necessary for biopharma manufacturers amid those changes, and 60% of them reported outsourcing at least some functions (such as DSCSA support, specialty storage/distribution, and sampling) to a 3PL.
Key Areas of Concern for Logistics Leaders
Leaders are particularly concerned about regulatory developments, Cardinal Health’s survey found. Nearly 4 in 10 executives said regulatory factors would be extremely or very disruptive to their organization’s future logistics goals.
Of the many potential disruptions in 2024 and beyond, one is compliance with DSCSA, which imposes certain track-and-trace and reporting requirements to keep counterfeit and illegitimate drugs out of U.S. circulation.
DSCSA was originally slated to go into effect in November 2023, but full enforcement has since been delayed for a year. Even with that extra “stabilization period”, manufacturers have a lot to do to get ready for DSCSA implementation—from establishing a serialization workflow to navigating reporting and exceptions.
“Manufacturers will definitely want to get affairs in order before DSCSA hits,” said Gary Davis, Technical Operations Director of 3PL Services at Cardinal Health, in the survey report. “It’s a delicate balance of making sure everything’s ready—and there are so many things to consider across the many touchpoints of the supply chain: Are your products serialized appropriately? Is your barcode quality high standard? Is the data transmitting all those components? It takes a lot of checks and balances to ensure the process is operating as it should so that there’s no impact to the patient.”
Other key areas of concern include the need for temperature-controlled warehousing and distribution, which has grown proportionally to the rise in cell and gene therapies: 29% of respondents cited improved temperature control solutions as a top needed improvement.
Transportation costs, which have outpaced an already high inflation rate, represented another top concern. More than a third—36%—of respondents said such costs would be extremely or very disruptive to their logistics goals.
Ongoing Value in 3PL Partners
Facing a bevy of stressors across market dynamics and compliance, biopharma manufacturers continue to see value in 3PLs. At the heart of those relationships is very often data, the survey found: 96% of respondents said that real-time data and analytics are important in understanding their companies’ pharma logistics operations.
Such insights point to the need to closely assess potential 3PLs across different dimensions of expertise, technologies, data transparency, and more, added Joel Wayment, Vice President of 3PL Services at Cardinal Health.
“An experienced biopharma 3PL can provide critical insights to industry trends as well as provide innovative solutions to meet the unique challenges being faced,” Wayment said. “A 3PL has the ability to scale up rapidly across facility space, talent, technology, and more—and can leverage key learnings from their experience to provide the right outcomes needed.”
For complete insights from the 2023 Cardinal Health and BioPharma Dive survey, download the report at Survey Report: Pharma Leaders on Evolving Logistics Demands, Free BioPharma Dive's studioID and Cardinal Health Survey Report.
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From the moment that our dedicated implementation team welcomes you into your engagement with us, our focus on customer experience is matched only by our expertise in order-to-cash; title model services; PDMA-compliant sampling solutions; end-to-end DSCSA support; integrated warehousing and distribution; telesolutions; and real-time reporting, data, and analytics. We’re more than a 3PL—we’re your true partner in commercialization. Together, we enhance patient care.