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Demand Planning & Drug Pooling Optimize Investigator Study

A financially successful mid-sized pharmaceutical company determined that strategically supporting investigator initiated clinical research was a good opportunity to explore the safety and efficacy of one of its drug products in new indications.

Stock Outs

The company assigned the growing clinical supply chain tasks to a recently hired consultant. Just four months after he arrived on the scene the trials began to stock out. By this time the number of investigator initiated trials had grown to over 100 studies and several thousand patients.

Having utilized Fisher Clinical Services for supply chain oversight of their registration trials the company contacted Fisher Clinical Services for help. The Fisher Clinical Services Supply Chain Manager recognized that the consultant had not developed a demand plan nor had he been tracking important details such as packaging configurations, patient enrollment and drug expiry. Realizing that a clinical supply chain is dependent on a strong foundational base of data collection and forecasting, she utilized an industry leading forecasting simulation tool to develop a demand forecast across all 100 studies.

Building an Accurate Demand Plan

To develop a robust forecast, she needed to build assumptions around drug quantities, dosage and patient enrollment. Physicians and investigator site staff, inexperienced in setting up or managing clinical supply chains, often do not have the expertise to drive these projections.

Turning instead to the pharmaceutical company’s clinical teams for insight on drug utilization in these trials a series of assumptions were built in order to feed demand projections across the 100 trials. Upon completion of the initial demand plan, the Fisher Clinical Services Supply Chain Manager validated the results with the company’s operational teams. When the demand projection for investigational drug showed it would actually outpace commercial demand, the Supply Chain Manager recognized that the first pass assumptions needed greater scrutiny.

After additional data collection and further collaboration with the clinical team, clinical supplies and commercial manufacturing, the Supply Chain Manager determined the company’s initial assumptions were mistaken in projecting linear enrollment and patient dosing over 24 months. Digging into data used for marketing authorization of the commercial drug she determined that the average time on drug during a two year period was actually just 18 months. Knowing that the patient population for these trials was limited, she also revised the linear enrollment statistics to modify the clinical supply forecast. Careful analysis of the dosing schedule, particularly in regard to the utilization of titration vs. a standard dosing regimen, provided additional insight into how to optimize drug demand.

With a solid demand plan in hand, and agreement from the pharmaceutical company’s clinical and clinical supply teams as well as operational staff, the Fisher Clinical Service Supply Chain Manager began looking at creative ways to minimize drug wastage across the 100 studies while mitigating expiry issues.

Product Pooling is the Answer

Ultimately, she determined that product pooling was the ideal solution in this case. By packaging in bulk across several protocols at once and then applying variable text on custom labels just in time for shipment to the sites, the pharmaceutical company could leverage available supply while easily matching demand.

Savings Across the Study Lifetime

By utilizing the pooling strategy and more accurate demand plan the pharmaceutical company was able to utilize 30% fewer lots than would have been needed under it original supply strategy, ultimately saving the company a projected $10 million USD over two years.

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