Pooled inventory and Just In Time labeling (JTL) meets demand for multiple channels

When a trial drug returns compelling results during early phases of a study, and when the drug has been developed to fulfilL an unmet need and give patients with serious or life-threatening conditions an opportunity to improve their quality of life or extend their life expectancy, regulators may choose to fast track drug approvals.

Early commercialization provides evident benefits to patients in need of vital treatment but, when the drug is required for both commercial purposes and continued, extended clinical trial use, the impact on supply and demand processes can be overwhelming.

For one, small oncology-focused pharmaceutical company, the impressive results of its trial drug in a Phase 3 study led to the regulator providing fast track designation for review. This resulted in earlier than anticipated commercialization and to franchising of the trial to explore its performance, when combined with other therapeutics, across multiple disease types.

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