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Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs

Summary: Securing timely and reliable commercial packaging services can be challenging for orphan, niche, and other low-volume drugs that must compete against high-volume drugs for access to finite production capacity at contract packagers. For the typical contract packager, high-volume drugs are given scheduling priority; low-volume jobs are slotted as gaps become available between larger projects. This common practice makes it challenging to find timely and predictable commercial packaging for low-volume products. For patients for whom the drug in question may be the only therapeutic option available, any delay in packaging that results in a market shortage can have serious consequences. Companies with orphan, niche, and low-volume drug products have options other than large-scale contract manufacturing services. This webinar describes one solution: Working with a clinical supply partner to handle the packaging and potential complex distribution logistics for expanded access programs and commercial supply.

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