U.S. Commercial Supply Chain for Hematology Drug Launch
Challenge
With a late-stage small molecule inhibitor approaching U.S. regulatory approval for hematological malignancy, the client possessed upstream manufacturing capabilities (API, drug substance, and drug product) but lacked the downstream commercial infrastructure required for U.S. market entry, including distribution networks, serialization compliance, inventory strategy and service-level agreements.
Solution
Alacrita’s supply chain consultants, in collaboration with Kadow Management, conducted a comprehensive situational analysis and gap assessment, then developed a launch-aligned roadmap addressing financial and tax structures for finished goods and intermediates, legal entity design for manufacturing and distribution and product safety protocols impacting cold-chain storage and specialty distribution. Serialization compliance under the Drug Supply Chain Security Act, volume forecasting and inventory positioning strategies and packaging configurations and early access program logistics formed another phase of strategy. And qualified vendor recommendations for U.S. 3PL, specialty pharmacy and patient support services rounded out the solutions.
Outcome
The roadmap enabled the client to establish U.S. commercial readiness in alignment with anticipated FDA approval timelines, ensuring compliant, cost-effective product availability to specialist treatment centers while optimizing service levels and margin impact.