Building Better Resilience Into Your Clinical Supply Strategy

By Life Science Connect Editorial Staff

When drug supply is reliable and consistent, a trial is poised to run smoothly. However, when clinical supply is delayed, damaged, overstocked, or insufficient, it can trigger a major chain reaction: disruptions to trials that damage enrollment, delay timelines, and increase costs. Amid a clinical climate marked by difficult-to-forecast enrollment, shifting country requirements, limited manufacturing capacity, and shipment delays, the question is how to develop a resilient supply chain built to handle these inherent shockwaves.

In a recent Outsourced Pharma Live Event, Clinical Supply Therapy: Lowering Risk (And Your Blood Pressure), Deputy Chief Editor of Outsourced Pharma Jeff Buguliskis interviewed an expert panel featuring:

• Elisha Lowe, Founder, Principal, IRL Life Sciences Partners
• Lisamarie Georgen, Founder, Principal Consultant, GuidedPath Consultants
• Steven A. Jacobs, President, Global Biopharm Solutions.

Their insights included practical approaches for creating true clinical supply resiliency and ensuring continuous support for sites and patients.

How Do Sponsors Demonstrate Resilience In Clinical Supply?

Lowe, who has worked across sponsors, CROs, and sites, defined resilience as a system that absorbs stress without transferring it to patients or sites: “The issue is primarily decision coordination, i.e., getting the right supplies to the right patients at the right time. Resilience comes down to governance, decision ownership, escalation pathways, communication, and patient protection.”

To ensure true fortitude, sponsors must be flexible and adaptable, which requires contingency plans and risk assessments. Ongoing transparency among stakeholders also supports a continuous clinical supply for patients and sites. The importance of this cross-functional collaboration was never more apparent than during the COVID-19 pandemic, when the relationship between vendors and sponsors was critical to vaccine distribution. “Vendors created execution teams to handle all challenges as rapidly as possible,” noted Jacobs. “We did an incredible job getting vaccines on the market. Unfortunately, in the aftermath, we’ve learned that these things are only possible when everyone is working together.”

What Are The Biggest Risks In Clinical Supply?

The pandemic also forced the industry to recognize the interdependence of clinical systems and the role clinical supply teams should play in upstream discussions. Consider the risks that impact reliable clinical supply and trial execution, and how better system integration and communication can help prevent them.

• Geopolitical challenges and transportation delays: International trade tensions, tariffs, and conflicts can significantly impact supply chains. Stringent international trade laws also lead to customs delays when shipping supplies across borders. During the pandemic, overnight deliveries and air transport were reduced significantly, impacting clinical supply. Now, with fuel scarcity and high costs, sponsors and their partners must stay prepared for transportation delays by developing backup plans.
• Regulatory obstacles: As sponsors seek approval across multiple jurisdictions, teams must remain compliant with each approving country’s regulatory guidance, including manufacturing and quality control standards, documentation best practices, labeling requirements, timelines, and controlled substance protocols.
• Protocol amendments: Because amendments can impact dosage, patient population, and/or study duration, they can lead to overstocking, shortages, drug expiration, waste, operational delays, and regulatory missteps. To minimize the risk that a protocol change will harm clinical supply, be sure to include the clinical supply team in the conversation during protocol design.
• Miscommunication and organizational silos: Lack of communication between clinical operations and clinical supply on enrollment and feasibility can result in forecasting errors, and poor forecasting will require constant last-minute adjustments that overburden teams. However, cross-functional discussions help alleviate miscommunications and disruptions.
• Vendor mismatches: Working with a poorly matched CDMO is a major risk. For example, a small biotech may select a huge CDMO that fails to provide the support, guidance, project management, and continuity required to be as proactive as possible. Sponsors must do their due diligence to determine whether a CDMO is a good cultural fit as well as a high-quality partner. 

What Is The Recovery Playbook For Site Disruptions?

In the clinical space, something will inevitably go awry, potentially interrupting the reliable flow of materials to a site. The key to success is how well sites recover. “It’s not about having a Plan A and a Plan B, it’s about having Plan A through Plan Z,” said Georgen.

Lowe posited a four-point playbook: “Patient safety, fast communication, decision ownership, and closing the loop. Can the therapy still get to the participant safely? Are we communicating quickly? Is there a designated person that will make the decision?”

For his part, Jacobs suggested the three Ts: tools, training, and team. “What are the tools that we have?” he asked. “How will we rely on the team to make sure this happens?” Thus, the theme for recovery is robust back-up planning, rapid problem-solving, and designated point people.

How Does Greater Patient Centricity Prevent Failures In The First Place?

There is an ongoing push to better incorporate patient perspectives from the outset via focus groups, patient advocacy groups, and clinical summits that discuss how packaging and labeling decisions impact adherence and retention in clinical trials. But Lowe noted that there is still much work to be done: “In a conversation with the CEO and CSO of a drug organization, I asked, ‘What are patients telling you?’ And they responded, ‘We don’t talk to patients.’ It stuck with me because it means we are still creating things for patients without their input. We have not yet structurally embedded patient centricity.”

To improve patient experience, it is important to incorporate patient and site perspectives as soon as possible to inform trial and protocol design rather than trying to retroactively fit a trial to suit its participants. As direct-to-patient initiatives expand, sponsors must ensure proper training, feasibility, and regulatory compliance to make these efforts functional.

Will AI Help Alleviate These Challenges?

Despite growing use of AI across the pharma industry, there is still caution around leveraging the technology to alleviate clinical supply challenges. Per Georgen: “From what I’ve seen, there is hesitation toward making AI an active part of running clinical trials, especially with clinical supply. There has been talk around using it for forecasting, but there are still many unknowns which have made sponsors pull back. There is this idea of, Let’s wait and see what somebody else finds out first.”

But ultimately, agentic AI offers the possibility for no-code or low-code programming to automate enterprise resource planning (ERP) systems that are challenging for clinical suppliers to navigate. It also allows you to monitor regulatory updates and changes. To succeed, agentic AI requires an experienced team that understands implementation and will monitor it for hallucinations and failures.

“When I look at forecasting, planning, and linking to interactive response technology [IRT] or randomization and trial supply management [RTSM] systems, AI shows tremendous promise,” said Jacobs. The key to success is recognizing where human touch will always be essential: contextual judgment, regulatory interpretation, ethical tradeoffs, and patient communication.

How Do Sponsors Protect Their Clinical Supply?

Reliable clinical supply requires proper vendor selection, robust cross-functional and cross-organizational communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design, allowing teams to optimize their timing, forecasting, and vendor strategy.