Challenge:

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.

Solution:

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.
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