
How a late-stage biotech company improved its ability to plan for clinical uncertainty while preparing for commercial launch.
For a late-stage biotech company running nearly 10 clinical trials while preparing for its first commercial launch, supply planning had become increasingly difficult.
The company had a small supply chain team and relied on Excel for planning. With so many trials running simultaneously, each with different enrollment assumptions, timelines, and supply requirements, keeping the plans current was a challenge. Updates from Clinical Operations were not always readily available, making it even harder to predict when and how much drug supply would be needed.
The team faced a familiar dilemma in biotech: how much Drug Substance (DS) and Drug Product (DP) should they manufacture?
Making too little could put clinical trials at risk. But making too much was equally concerning. With expensive materials, limited shelf life, and cash resources that needed to be carefully managed, excess inventory could come at a significant cost.
Meanwhile, preparations for commercial launch brought even more uncertainty. The team needed to consider different launch scenarios while continuing to support existing clinical programs.
They needed a better way to evaluate these possibilities and make supply decisions without constantly reworking their Excel models.
After seeing a demonstration of ABC-Plan's Clinical Demand Simulator and The Master Planner, the team realized they could address two of their biggest planning challenges in one connected system.
Clinical Demand Simulator allowed the team to model demand across multiple trials using different assumptions for patient enrollment, dosing, and study timelines. Instead of maintaining numerous spreadsheet scenarios, planners could quickly explore different possibilities and understand how changes in clinical assumptions would affect future supply requirements.
The Master Planner took those clinical demand projections and combined them with anticipated commercial demand from Sales Operations, giving the company an integrated view of its future supply needs.
With its constraint-based optimization engine, The Master Planner helped the team evaluate manufacturing and inventory decisions while considering manufacturing capacities, lead times, batch sizes, shelf life, and other supply constraints.
This was particularly valuable given the high cost of their drug substance. The goal wasn't simply to minimize inventory or maximize supply. It was to find a reasonable balance between the risk of running short and the financial consequences of producing too much.
For the first time, the team had a way to plan clinical and commercial supply together, rather than treating them as separate planning exercises.
Timing was important. The company had an upcoming Long-Range Planning (LRP) project and wanted to use ABC-Plan as part of that process.
Rather than waiting for integrations with its Interactive Response Technology (IRT) system and future ERP system, the company decided to take a phased approach.
The initial implementation was completed in just one week.
This allowed the supply chain team to begin using both the Clinical Demand Simulator and The Master Planner immediately, while leaving system integrations for a later phase.
For a small team with limited IT resources, this was an important consideration. They could start addressing their planning challenges without taking on a lengthy implementation project.
With ABC-Plan in place, the company gained a more structured and flexible approach to supply planning at a critical stage of its growth.
The team could now evaluate different clinical demand scenarios, examine the supply implications of changing assumptions, and bring clinical and anticipated commercial requirements together in one planning environment.
The Master Planner also provided a way to assess the trade-offs between supply availability and excess inventory, helping the team make more informed DS and DP manufacturing decisions.
Perhaps most importantly, the company was able to put these capabilities to use in time for its LRP project, without waiting for a full system integration.
While uncertainty in clinical development will never disappear, the team now had better tools to understand its potential impact and adjust plans as assumptions changed.
As the company moves closer to commercial launch, its planning needs will continue to evolve. Clinical trials will still require reliable supply, while commercial demand will introduce new forecasting, inventory, and manufacturing considerations.
By bringing clinical demand simulation and integrated supply planning into one system, ABC-Plan provides a foundation that can support both sides of the business as it grows.
For emerging biotech companies facing similar challenges, the lesson is straightforward: there is no need to wait for an ERP implementation to benefit from advanced supply planning. The right planning solution can deliver immediate value today and continue to play an essential role alongside ERP as the business grows.
Sometimes, the greatest value comes from having the right planning tools available when important decisions need to be made.