The Challenge
A promising Belgian pharmaceutical start-up company was in the third testing phase for one of their leading orphan drugs. Passing successfully the 3rd testing phase will allow a pharmaceutical company to actively sell the developed drug. Up to, and during, this testing phase a pharmaceutical start-up company generally is purely focused on research and development with some manufacturing and procurement happening. Any further support organisation is only there to allow the drug development and the related small scale clinical testing to happen.
The pharmaceutical start-up company as a result required a complete downstream supply chain to be set up, so that they could immediately start selling their drug once approved.
ESCIMCO was tasked with setting up the complete European downstream supply chain for this cold-chain and limited shelf-life orphan drug.
The Approach
Based on the initial conversations ESCIMCO created a project road map, and a more granular project plan, for which weekly status updates were given. This allowed the pharmaceutical start-up company to have full visibility on the project progress.
Considering that there was no downstream supply chain available, ESCIMCO created a comprehensive list of the ‘Order-to-Cash’ processes required to manage the downstream supply chain. In close consultation with the respective functions in the pharmaceutical start-up company ESCIMCO mapped out all the ‘Order-to-Cash’ processes in process flows, and assured that any process gaps were closed. Consequently ESCIMCO created validated GxP-documents covering all the required ‘Order-to-Cash’ processes.
Using the process mapping the pharmaceutical start up company and ESCIMCO determined the processes that would be outsourced. Based on this decision ESCIMCO started the tendering process, preparing all documentation and long listing candidates from known logistics services providers for the pharmaceutical industry. Through the thorough tendering process the pharmaceutical start-up company selected the most ideal logistics services provider and negotiated a multi-year contract. ESCIMCO consequently aligned with, tested and implemented the ‘Order-to-Cash’ processes at the logistics services provider.
Based on the Directive 2011/62/EU certain medicines require a specific anti-tampering device and a unique identifier applied to each package. The unique identifier is stored in a European data repository with which physicians and pharmacists can verify the authenticity of the medicines they hand out. ESCIMCO has set up and tested the required cloud-based software, which assures that the sub-contracted orphan drug packager applies the correct unique identifiers under the authority of the pharmaceutical start-up company.
The Results
ESCIMCO implemented the complete European downstream supply chain within the timeline agreed, which allowed the Belgian pharmaceutical start up company to successfully bring their orphan drug to the market and start generating revenue after a decade of research and development.
