A federal agency was concerned about the risks associated with outsourcing their pharmaceuticals. They faced four problems. A large portion of their active pharmaceutical ingredients were being sourced from countries representing political or economic risk. Government standards for labeling the “country of origin” of their drugs were inconsistent and insufficient. Drug manufacturers regarded their sources of supply as trade secrets and were reluctant to reveal them. And mergers and acquisitions of generic drug manufacturers had gradually reduced competition, leading to rising prices, and shortages.
To solve these problems, the agency needed visibility across their pharmaceutical supply chain. They engaged Supply Dynamics to build a prototype visibility and analytics platform so they could map the supply chain of several critical drugs.
We set to work developing core modifications to SDX, our proven visibility and analytics platform for metals, plastics, and electronic components. Adapting SDX to the pharmaceutical industry was a natural extension of our expertise.
In the development of our pharmaceutical prototype, we consulted subject matter experts in pharmaceuticals and risk analysis. We identified the best curated sources of drug data and designed a method for automatically mapping this data in SDX. We analyzed 20 drugs on the FDA List of ‘Essential Medicines’ to build a corpus of data for testing and proof of concept. The result was a functional prototype that could be scaled for use in a government or commercial environment.
Our drug mapping process resulted in detailed pharmaceutical ‘Bills of Materials.’ For each of the 20 drugs, we detailed attributes and potential sources of supply, mapping hierarchies of finished drugs with their constituent ingredients. Drug by drug, we uncovered numerous unique formulations of ingredients, technical characteristics and countries of origin. Our solution succeeded in automatically mapping – without human intervention – drug ingredients, active pharmaceutical ingredients, excipients and chemical precursors. These attributes were then loaded into SDX where users could view and manage the data, report on it as needed, and geographically visualize the different tiers of supply. Risk data for each supplier was loaded, enabling strategic decision making based on their impact on the value chain.
We mapped the supply chain of 20 essential drugs and developed a prototype of a ‘Pharmaceutical Provenance Solution.” The project is now headed for deployment in government & commercial operational environments.