Clarkston recently partnered with a biotechnology firm on a developing COGS (Cost of Goods Sold) model for their Biologics Licensing Application (BLA) filing with the FDA.
This client is a publicly listed, clinical-stage biotechnology company focused on discovery, development, and commercialization of biotherapeutics for treatment of cancer and various autoimmune and inflammatory diseases. In advance of Biologics Licensing Application (BLA) filing with the FDA, commercialization and growth planning, this client engaged Clarkston to develop operations data models central to their strategic finance and supply decision-making.
Informed by the current state processes as well as commercial future state, strategic planning and process modeling tools were developed to be leveraged for additional pipeline assets as well as to enable and inform the implementation of an ERP solution. This included the development of a strategic supply/demand planning model, COGS models for the client’s two lead drug candidates, the build-out of Bill of Materials and a part numbering scheme for those products, and the documentation of as-is clinical and to-be commercial supply chain process maps.
Some of the key impacts of developing COGS models were:
- Improved visibility into supply chain and financial operations
- Enhanced tools and models to empower decision-making
- Increased organizational understanding and alignment on key activities relative to supply and demand planning