Our client was a publicly-traded clinical-stage biopharmaceutical company using an epigenetic approach modulate gene expression in tumor and immune cells to treat cancer. Their lead program was a small molecule inhibitor in late-stage clinical development for a hematological malignancy. In preparation for regulatory approval and launch in US, Alacrita was asked for support to help design and create a roadmap for setting up a commercial supply chain for the drug. The company had an upstream supply chain in place (API, DS, and DP manufacture), but no downstream elements yet in place.
Alacrita’s supply chain experts worked closely with functional representatives of the client through a work plan involving a situational analysis, definition of the supply chain requirements, a gap analysis, and mapping required activities and dependencies to a launch timeline.
The roadmap took into account the following items:
- Financial and tax set up for finished goods, intermediates, and raw materials
- The company legal structure as it relates to manufacturing and distribution of product
- Product safety considerations and their impact on storage and distribution
- Product serialization
- Volume forecasting
- Inventory strategy, likely stock holding points and finish-to-order concepts
- Packaging design and configurations
- Customer service requirements
- Early access programs
- Service level agreements and impact on margin
- Supply chain vendor recommendations.