A peer-exchange roundtable of industry leaders argued that resilience must be a continuous, systems-level discipline. Panellists warned that package-level traceability gaps and misaligned data under DSCSA can force quarantines and cascade into medicine shortages, and recommended standards-based exchanges, clear exception workflows, supplier diversification and measured regulatory collaboration.
According to the original report in Pharmaceutical Commerce, a recent peer‑exchange roundtable made clear that the pharmaceutical supply chain is far from a series of discrete handoffs; it is an interdependent, multi‑stage system whose resilience determines whether patients receive safe, authentic medicines on time. Moderated by Nicholas Saraceno, the discussion brought together Dave Malenfant, Opeyemi Odusami and Bob Celeste to probe where fragility still hides in the system and what practical steps industry, regulators and trading partners should take to strengthen it.
Malenfant urged participants to adopt a holistic, circular view of the network — “plan, source, make, deliver, sell, sustain, and return” — and to treat resiliency as a continuous management discipline rather than a one‑off project. That perspective sits comfortably with established supply‑chain frameworks such as the SCOR model, which encourages organisations to map end‑to‑end processes, benchmark performance and build digital and governance capabilities that enable orchestration across partners. In practice, that means linking process design, performance metrics and digital interoperability so that a problem in sourcing or manufacturing does not cascade downstream into patient access failures.
Odusami underlined that resilience is as much about anticipation as reaction. Synchronising purchasing, manufacturing and logistics, and building adaptability into those systems, enables companies to predict and prevent disruption rather than merely respond to it. That approach echoes public‑health guidance: the World Health Organization emphasises forecasting, robust procurement and supply‑management tools as essential to keeping essential medicines available, affordable and of assured quality. The roundtable therefore framed data and planning — not just capacity alone — as core resilience levers.
A striking strand of the conversation focused on serialization, data alignment and exception handling. As Celeste noted during the roundtable, when regions increasingly require package‑level traceability, physical goods and transmitted data can fall out of step; “misalignment errors often result in products being placed in quarantine,” he said, creating time‑sensitive bottlenecks. The U.S. Drug Supply Chain Security Act (DSCSA) aims to build an electronic, interoperable system for tracing prescription drugs at the package level, including product identifiers and transaction histories, but the reality of implementation is that exceptions will arise. Industry commentary warns that without robust pre‑testing, standardised data formats and clear exception‑management workflows, wholesalers and distributors may be forced to quarantine, return or investigate shipments — actions that can produce cascading delays and unintentionally contribute to shortages.
Those shortages, the panel agreed, are rarely the result of a single cause. Peer‑reviewed research highlights several structural drivers: low profitability for many generics and sterile injectables reduces incentives for multiple high‑quality suppliers; quality problems at manufacturing sites; complex regulatory requirements; and concentration in API supply chains, often overseas. The roundtable echoed those findings, pointing out that an inability to source active pharmaceutical ingredients frequently manifests later as hospital and community‑level shortages.
Against that backdrop, the conversation produced a pragmatic menu of actions rather than a single silver bullet. Panelists and industry analysts advocate:
– strengthening data governance and interoperability so trading partners can detect and resolve mismatches quickly;
– implementing rigorous pre‑testing and standards‑based exchanges to lower false positives;
– designing exception‑handling processes with clear roles, SLAs and escalation paths so quarantines are short and informed;
– diversifying supplier bases for critical APIs and essential medicines where feasible, while combining that with incentives for high‑quality domestic and international manufacturing;
– investing in talent pipelines and cross‑functional capability so organisations have the skills to operate in a more data‑intensive environment; and
– embedding sustainability and circularity into planning to reduce waste and long‑term supply risk.
The roundtable also cautioned against policy or commercial overreactions. Sudden stockpiling or wholesale reshoring in response to tariff changes or geopolitical noise can be costly and create its own logistical and quality challenges. The participants argued for measured trade and procurement strategies that balance risk reduction with operational efficiency — in other words, building resilience without imposing unnecessary cost and complexity that could reduce long‑term access.
Regulators have a role to play in this balanced approach. The FDA’s DSCSA framework sets traceability expectations intended to protect patients by enabling rapid detection and removal of suspect products, but the agency and industry must continue to collaborate on implementation timelines, trading‑partner definitions and practical enforcement that account for real‑world exception rates. Similarly, policymakers can consider targeted incentives and procurement reforms identified in academic work to encourage investment in high‑quality, reliable manufacturing for low‑margin essential medicines.
The roundtable’s central claim is straightforward: protecting patient access requires systems thinking. That means aligning policy, commercial incentives, technology standards and human capability around a common objective — steady supply of safe, affordable medicines — rather than reacting in siloed ways to each new disruption. Building that end‑to‑end capacity will take time and coordinated investment, but the alternative is a supply chain in which a single misaligned data message or constrained API source can quickly ripple into a public‑health problem.
Source: Noah Wire Services
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