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An emerging pharmaceutical client was conducting a randomized and blinded pivotal Phase III clinical trial. Expanding the trial footprint would require increased supply and company leadership wanted confirmation that another manufacturing run was absolutely necessary before committing to that multimillion-dollar investment.
The internal resource charged with supply planning was part of the Clinical Operations team. Due to the individual’s clinical operations responsibilities, they were blinded in order to maintain the integrity of the study. However, to truly examine the demand/supply dynamics and assess manufacturing requirements, access to unblinded data was necessary. Management engaged Converge to analyze the demand/supply situation, prioritize supply issues and resolutions, and proactively manage clinical supply chain activity.
With a Supply Plan, Demand Plan, and Manufacturing Plan in place, the client now has a clear picture of their clinical supply chain and tools to manage it going forward.
Our initial supply assessment confirmed the need for a manufacturing run to ensure no interruption to the clinical trials. Our further work enabled the company to consider accelerating geographic expansion with confidence in supply continuity.
Today, our role is maintaining and actively managing the clinical demand and supply planning process. Converge also supports Clinical Operations with proactive planning, along with investigating and mitigating site-related, inventory-related, and IRT-related supply chain issues.
Their Senior Director of Clinical Operations has comprehensive end-to-end visibility into the clinical supply chain, and a trusted partner managing the plans on their behalf from strategy to execution.
To verify whether they needed another manufacturing run, Converge conducted a supply availability assessment. Results showed the amount of supply required for the company’s active trials as well as the planned expansion. The assessment also confirmed that they needed another manufacturing run to ensure adequate supply.
After resolving the question of further investment, we collaborated with this client to develop a set of spreadsheet-based supply planning tools. The first of these was the Supply Plan, which provided data to improve their overall supply position.
Focus then shifted to demand planning. A Demand Plan establishes the amount of drug needed for a study based on how the company expects patients to enroll. It identifies critical study-specific variables such as total number of patients/countries involved and active enrollment rates. Then, it captures those values at a given moment in time. This company’s Demand Plan would be updated with real-time enrollment data and factor in anticipated future enrollment.
Demand Plan information flowed back into the Supply Plan and forward into what would become a documented Manufacturing Plan.
Working with the client’s CMC leaders, we built a shared understanding of key factors such as batch sizes, limitations, drug expiry/shelf life, and typical losses. This information yielded a Manufacturing Plan enabling optimization of several shelf-life extension activities with the packaging and labeling vendor.
An emerging pharmaceutical company conducting a pivotal Phase III trial needed to assess whether a multimillion-dollar manufacturing run was necessary before expanding their trial footprint. Their internal supply planner was blinded to maintain study integrity, preventing accurate demand/supply analysis. Converge conducted a supply availability assessment that confirmed the need for additional manufacturing, then developed integrated planning tools—a Supply Plan, Demand Plan, and Manufacturing Plan—providing real-time visibility into their clinical supply chain. These tools enabled proactive supply management and gave leadership confidence to accelerate geographic expansion while Converge continues to actively manage the planning process from strategy to execution.
