Tariffs Threaten Clinical Trial Supply Chains: Preparing For Volatility

By Kevin Coker, JD, MPH, MS, innovation strategist MD Anderson Cancer Center

Operational Accountability In Clinical Trials

I lead medical device development activities at MD Anderson Cancer Center and have been involved in drug development activities over the last two decades in various executive roles at CROs and sites. I work closely with industry sponsors, clinical operations teams, contract manufacturers, and regulatory partners to advance complex oncology programs. In that role, I am accountable not only for scientific progress but for the operational integrity required to translate promising concepts into executable clinical trials. That accountability is very tangible. When supply does not arrive on time, when a protocol amendment is delayed, when contracts are delayed/renegotiated, or when a manufacturing change stalls at review, the downstream effects are felt by investigators, coordinators, sponsors, and —most importantly — patients.

Over the last several years, and with increasing intensity more recently, two forces have begun to reshape the practical realities of clinical development: the reemergence of tariffs affecting pharmaceuticals and medical devices and persistent staffing shortages at the FDA. Neither issue is theoretical. Both are already influencing how trials are budgeted, supplied, regulated, and delivered. And for those of us operating inside academic medical centers and complex development ecosystems, their combined effect is changing how we think about risk, timing, and execution.

What makes this moment particularly challenging is not either issue in isolation but their interaction. Tariffs introduce cost volatility, sourcing uncertainty, and friction into supply chains that were designed for predictability and just-in-time execution. FDA staffing constraints reduce flexibility at the very moment when sponsors and sites need faster feedback, more frequent interaction, and greater regulatory clarity. Together, these forces are forcing a reassessment of assumptions that many of us have relied on for years.

Global Inputs, Local Consequences

Clinical trials may be executed locally, but they are built on deeply global supply networks. Active pharmaceutical ingredients (APIs), comparator drugs, excipients, sterile packaging components, delivery devices, and diagnostic assays often traverse multiple countries before reaching a patient. For decades, this globalization supported efficiency, redundancy, and scale. It allowed sponsors to optimize for quality, cost, and reliability across borders.

That same globalization now exposes clinical development programs to trade policy decisions that were historically viewed as peripheral. When tariffs are applied anywhere along the pharmaceutical or medical device supply chain, the impact does not stop at commercial distribution. It reaches investigational supply almost immediately. Industry analysts estimate that a broad 25 percent tariff on pharmaceutical imports could increase U.S. drug costs by more than $50 billion annually.¹ While these figures are often discussed in the context of commercial pricing and reimbursement, the same cost pressure exists during development, where volumes are smaller, margins are nonexistent, and budgets are fixed long before the first shipment moves.

From an operational standpoint, tariffs disrupt sourcing strategies that were deliberately built around supplier performance, quality systems, and regulatory track record. A supplier does not suddenly become noncompliant because a tariff is introduced, but lead times can extend, customs clearance becomes less predictable, and cost structures shift in ways that ripple through development budgets. In a regulated environment, responding to those changes is slow by design. Switching or supplementing suppliers requires qualification activities, analytical comparability work, stability data, chemistry, manufacturing, and controls (CMC) updates, and often regulatory notification or approval. These are necessary safeguards, but they also mean that supply chain flexibility is constrained precisely when volatility increases.

Stress Fractures In Clinical Supply Chains

Industry surveys suggest that more than 80 percent of biotechnology companies would require at least 12 months to replace a key supplier disrupted by tariffs, with nearly half estimating timelines that exceed two years.² In clinical development, those timelines have direct and measurable consequences. Supplier transitions that slip by months translate into delayed site activation, deferred first-patient-in milestones, and uneven investigational product availability across regions.

Late-phase and registrational studies are particularly exposed. At that stage, enrollment momentum and data continuity are critical. Interruptions in supply do not simply slow progress — they can jeopardize statistical power, increase protocol deviations, and introduce bias. From an operational perspective, the cost of restarting momentum often exceeds the cost of preventing disruption in the first place.

To mitigate tariff uncertainty, sponsors increasingly advance inventory build schedules and carry higher levels of safety stock. I understand the logic. No one wants a trial to pause because a shipment is held at customs or repriced unexpectedly. But this approach introduces its own risks. Larger inventory positions increase working capital requirements and raise the probability of expiry, particularly for biologics, cell therapies, and gene-modified products with limited shelf life. Inventory that was once staged dynamically must now be committed earlier, reducing flexibility to adapt to protocol amendments, competitive landscape changes, or enrollment variability.

Oncology trials illustrate these challenges clearly. Comparator therapies are often branded products manufactured outside the United States and sourced through complex commercial channels. When those supplies are delayed, repriced, or reclassified for customs purposes, enrollment may pause entirely because patients cannot ethically or statistically be randomized without assured access to all treatment arms. I have seen situations where sites were contracted, staff were trained, and patients were identified, yet enrollment could not begin because the comparator supply was uncertain.

Customs clearance has become another pressure point. Heightened scrutiny of tariff classifications and import documentation has made clearance timelines less predictable.³ For temperature-controlled investigational products, even short delays can compromise validated shipping lanes. In some cases, teams are forced to redesign depot strategies or transportation routes mid-study, absorbing additional cost and documentation burden simply to keep product moving.

Ancillary supplies add a further layer of vulnerability. Administration devices, infusion sets, diagnostic kits, and specialized packaging components are often sourced independently from the investigational product itself. When tariffs affect these items unevenly, sites may receive the drug but lack the tools required to administer it or assess eligibility in compliance with the protocol. These mismatches are operationally frustrating and entirely avoidable, yet they continue to surface as supply chains become more fragmented.

What To Do About It

Tariff volatility is now an operational reality in clinical development. Teams can reduce downstream disruption by acting earlier and more deliberately:

• Map tariff exposure across the entire clinical supply chain, including APIs, comparators, ancillary devices, and packaging, not just the investigational product.
• Identify single-point supplier dependencies early and assess qualification timelines for alternates before disruption occurs.
• Model cost and timing scenarios that incorporate tariff escalation, customs delays, and inventory expiry risk.
• Align clinical, manufacturing, and regulatory teams around shared assumptions so mitigation strategies do not introduce unintended compliance or execution delays.

This article is part one of a three-part series. In the next article, I will continue the conversation by examining how FDA staffing constraints are compounding these supply chain pressures, and what that means for timelines, regulatory strategy, and operational risk in clinical trials. Watch for it and comment with your thoughts or reach out for clarification.

References:

1. Reuters. U.S. pharma tariffs would raise U.S. drug costs by $51 billion annually, report finds. April 25, 2025.
2. Clinical Leader. The potential impact of U.S. tariffs on the biotech sector: Manufacturing, funding, and clinical trials.
3. Applied Clinical Trials. Future-proofing clinical trial supply chains against tariff risks

About The Author:

Kevin Coker, JD, MPH, MS, is innovation strategist and leads MedTech development at MD Anderson Cancer Center, the world’s top-ranked cancer center, and advisor to First Bight Investments, a venture fund/accelerator for synthetic biology and industrial biomanufacturing. Coker cofounded and was CEO of Proxima Clinical Research, a CRO ranked by Inc. Magazine as one of the fastest-growing companies in 2021 and 2022, earning more than 30 awards in its first seven years. He also founded M1MedTech, a virtual venture studio for medical devices, and co-hosted Inventing Tomorrow podcast. Coker has held senior leadership roles across biotech, MedTech, and clinical research, including board director at Volumetric Biotechnologies (acquired by 3D Systems), CEO of MolecularMatch, VP at Worldwide Clinical Trials, and VP, US Oncology Research at McKesson Corp. He holds degrees in biology, pathology, law, and public health and is certified in clinical molecular biology and U.S. regulatory affairs.