New solutions are emerging to address a growing exposure as advanced therapies continue to scale
The procedure was scheduled, the team was ready, and the patient had completed the long preparation required for an autologous cell therapy. But instead of an infusion, the call that came delivered a different outcome: the product could not be administered. Whether due to manufacturing delays, logistics breakdowns, or regulatory disruptions, the therapy the patient expected simply wasn’t available.
This kind of scenario is becoming more visible as cell and gene therapies expand. Unlike traditional pharmaceuticals, CGT products rely on complex, individualized supply chains—from the initial collection of patient material through manufacturing, quality release, transport, and final administration. When any link in that chain fails, a dose may not be available when needed. And in CGT, timing is often as critical as the treatment itself.
Some specialized logistics firms are stepping in to bridge a critical link in the cell & gene therapy (CGT) supply chain. Biocair, for example, offers dedicated “cell and gene supply chain” services that emphasize that when each dose is patient-specific, live, and time-sensitive, the logistics function moves from “just shipping” to “therapy enabling.” Disruptions in this type of chain — whether a temperature excursion, customs delay or documentation error — are not peripheral; they go to the heart of whether a patient ever receives the intended dose.
The industry is experiencing growing pressure as more therapies advance into late-stage trials and commercialization. Many programs depend on specialized manufacturing processes, capacity-constrained vector production, and tightly controlled logistics environments. Any disruption, even one outside an organization’s control, can affect product availability. For patients participating in clinical trials, product shortfalls can mean missed opportunities or complications arising from preparatory treatment that cannot be followed by the intended therapy.
This has created a parallel risk that traditional insurance policies were not designed to address. Clinical trials liability coverage is generally structured around adverse events resulting from receiving an investigational product—not harms that may arise when the product cannot be provided. General liability and product liability policies also tend to exclude or insufficiently cover supply-related failures. As a result, organizations developing or administering CGT products face potential exposures that fall through the gaps of existing insurance structures.
Conner Strong & Buckelew has introduced a new insurance solution designed specifically to respond to this challenge. The Product Shortage PLUS Endorsement, built in collaboration with Citadel Insurance Company and Cell One Partners, extends the BioPro Clinical Trials Liability insurance policy to address liability exposures arising from investigational product unavailability or delivery failure for qualified reasons.
Daniel S. Brettler, National Life Sciences Practice Leader at Conner Strong & Buckelew, emphasized why this coverage is needed: “Cell and gene therapies are transforming the healthcare landscape with pioneering new treatments and solutions, but the process is time-sensitive, posing significant risks and challenges.” He noted that current liability insurance policies “either do not address this exposure or fall short of fully protecting the insured.”
The Product Shortage PLUS Endorsement is built around four categories of exposure outlined in the company’s announcement. It includes coverage for patient claims arising from the unavailability of an investigational product, protection for operational failures related to collection to reinfusion, access to legal defense for claims brought against eligible insureds, and support for issues involving compliance with evolving guidance such as ICH, GCP, and FDA requirements. The goal is to offer sponsors and sites a more complete risk-transfer mechanism that aligns with the unique supply dynamics and individualized dosing models in CGT.
Gregory J. MacMichael, Vice President and Product Head at Citadel Insurance Company, underscored the strategic importance of addressing these exposures early. “The organizations that recognize and address these underestimated risks now will have significant competitive advantages as the industry scales from thousands to hundreds of thousands of patients annually,” he said.
The introduction of this coverage reflects a broader shift within the CGT sector. As new therapies move from small early-stage populations into larger multicenter trials and commercial availability, operational resilience becomes a core component of patient protection. Ensuring that investigational products can be delivered—or that organizations are protected when they cannot—has become part of the evolving infrastructure required to support CGT growth.
For sponsors, manufacturers, trial sites, and investors, the message is increasingly clear: scientific innovation alone is not enough. Advanced therapies depend on reliable systems, coordinated logistics, and insurance structures that recognize the realities of time-sensitive, individualized products.
Conner Strong & Buckelew’s Product Shortage PLUS Endorsement arrives at a time when the industry is looking closely at where its next vulnerabilities lie. As cell and gene therapy programs accelerate, ensuring protection across the full treatment and supply chain is becoming an essential part of bringing these groundbreaking therapies to patients safely and sustainably. We will continue to see new products and solutions arise to meet the evolving challenges associated with this maturing market.
